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	New
Form 1 CoC Applicants - Small business Form and Instruction	New
Form 1 CoC Applicants- State/local Form and Instruction	New
Form 1 CoC Applicants Private Form and Instruction	New
Form 1 CoC Applicants- Federal Form and Instruction	Removed
Form 1 CoC Applicants- Small Business Form and Instruction	Removed
Form 1 CoC Applicants- State and Local Form and Instruction	Removed
Form 1 CoC Applicants - Private Sector Form and Instruction	Removed
30-day FRN2016-26445.pdf Supplementary Document	2016-11-02
Attach 2 HHS CoC Coordinator list.doc Supplementary Document	2016-10-26
support_stmt_A coc online app system final.doc Supporting Statement A	2016-10-26

IC Document Collections

IC ID	Document Title	Status
224161	CoC Applicants -Federal Form and Instruction	New
224160	CoC Applicants - Small business Form and Instruction	New
224158	CoC Applicants- State/local Form and Instruction	New
224157	CoC Applicants Private Form and Instruction	New
209604	CoC Applicants- Federal Form and Instruction	Removed
209603	CoC Applicants- Small Business Form and Instruction	Removed
209602	CoC Applicants- State and Local Form and Instruction	Removed
209601	CoC Applicants - Private Sector Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0689	ICR Reference No: 201610-0925-002
Status: Historical Active	Previous ICR Reference No: 201312-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 20936
Title: Electronic Application for NIH Certificates of Confidentialty (CoC E-application System)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/21/2016
	Date Received in OIRA: 11/08/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2019	36 Months From Approved	01/31/2017
Responses	1,300	0	1,000
Time Burden (Hours)	1,951	0	1,500
Cost Burden (Dollars)	0	0	0

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Abstract: Certificates of Confidentiality provided research participants with an additional layer of protection by allowing researchers with a CoC to refuse compelled disclosure of identifying information about participants. NIH, through its 24 funding Institutes and Centers (ICs), has issued Certificates of Confidentiality since 1997 to researchers who request this protection. In 2015, to imporve the efficency of the CoC process, NIH launched an on-line application system for researchers to request a CoC from all the NIH ICs. The system allows researchers to submit an application with all required documentation, track its status and receive automatic email alerts when the status changes. It also allows NIH staff to move the application through each IC’s review and approval process, to generate the Certificate for IC signature, to maintain a record of all CoC requests and to generate basic system metrics.

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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:
	81 FR 55207	08/18/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 76370	11/02/2016
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	CoC On-line Application (Screenshots)
CoC Applicants- Federal	1	CoC On-line Application (Screenshots)
CoC Applicants Private	1	OEP CoC Application
CoC Applicants - Private Sector	1	CoC Online Application (Screenshots)
CoC Applicants- State and Local	1	CoC On-line Application ( Screenshots)
CoC Applicants -Federal	1	OEP CoC Application
CoC Applicants- State/local	1	OEP CoC Application
CoC Applicants - Small business	1	OEP CoC Application

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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	1,300	1,000	0	1,300	-1,000	0
Annual Time Burden (Hours)	1,951	1,500	0	1,951	-1,500	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: extension - Total burden hours have increased from the last submission due to the overall increase in the number of applications anticipated.

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Annual Cost to Federal Government: $42,870

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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: 11/08/2016

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