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

Forms and Documents

Document Name	Status
Form 1 CoC Applicants - Federal Form and Instruction	Modified
Form 1 CoC Applicants - Small Business Form and Instruction	Modified
Form 1 CoC Applicants - State/local Form and Instruction	Modified
Form 1 CoC Applications - Private Form and Instruction	Modified
Change Request Memo CoC System 030320.pdf Justification for No Material/Nonsubstantive Change	2020-03-04
COC 30-day Notice.pdf Supplementary Document	2019-12-20
Support_stmt_A coc online system final (3).docx Supporting Statement A	2020-01-27
Attachment 2 DHHS COC Coordinators (1).docx Supplementary Document	2019-12-03
CoC_PIA_HHS_2019.rtf Supplementary Document	2019-12-03
Privacy Act Memo.pdf Supplementary Document	2019-12-03

IC Document Collections

IC ID	Document Title	Status
238764	CoC Applicants - Federal Form and Instruction	Modified
238763	CoC Applicants - Small Business Form and Instruction	Modified
238762	CoC Applicants - State/local Form and Instruction	Modified
238761	CoC Applications - Private Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0689	ICR Reference No: 202003-0925-001
Status: Active	Previous ICR Reference No: 201912-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 20936
Title: Electronic Application for NIH Certificates of Confidentialty (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: 03/17/2020
	Date Received in OIRA: 03/05/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	02/28/2023	02/28/2023
Responses	529	0	529
Time Burden (Hours)	794	0	794
Cost Burden (Dollars)	0	0	0

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Abstract: NIH is requesting a revision for three years. In 2015, NIH launched an on-line application system for researchers to request a Certificate of Confidentiality (CoC) from NIH. Information is collected to allow confirmation of eligibility for a CoC and to issue a Certificate. Eligible requestors will receive an electronic Certificate once approved. Certificates of Confidentiality (CoCs) protect research participants, researchers, and institutions by prohibiting disclosure of identifying information about participants to persons not connected to the research, with limited exceptions. NIH, through its 24 funding Institutes and Centers (ICs), has issued Certificates of Confidentiality since 1997 to researchers who request this protection. NIH-funded researchers are now deemed issued a Certificate upon award of NIH funding and no longer 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:
	84 FR 40426	08/14/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 70199	12/20/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
CoC Applicants - Small Business	1	NIH Certificate of Confidentiality Request Form Screenshot
CoC Applications - Private	1	NIH Certificates of Confidentiality Request Form Screenshot
CoC Applicants - Federal	1	NIH Certificates of Confidentiality Request Form Screenshots
CoC Applicants - State/local	1	NIH Certificates of Confidentiality Request Form Screenshots

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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	529	529	0	0	0	0
Annual Time Burden (Hours)	794	794	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 21st Century Cures Act, enacted December 13, 2016 requires the DHHS Secretary to issue to investigators or institutions engaged in biomedical, behavioral, clinical, or other research in which identifiable, sensitive information is collected (“Covered Information”), a Certificate to protect the privacy of individuals who are subjects of such research, if the research is funded wholly or in part by the Federal Government. As a result, NIH now deems all NIH-funded research within the scope of the law and the NIH CoC policy issued a Certificate, thus a CoC request is no longer needed and no information is collected from NIH recipients. Total burden hours have decreased from 1951 to 794 from the previous submission due to automatic issuance of NIH-funded CoCs. NIH plans to further implement these requirements with a streamlined form and enhanced electronic system in 2020. Due to the timeline and resources needed for system development, the system will not be functional prior to expiration of the current clearance.

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Annual Cost to Federal Government: $117,616

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? Uncollected

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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: 03/05/2020

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