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

Forms and Documents

Document	Type	Status	Availability
Form 1 CoC Applicants- Federal	Form and Instruction	New	Repair queued
Form 1 CoC Applicants- Small Business	Form and Instruction	New	Repair queued
Form 1 CoC Applicants- State and Local	Form and Instruction	New	Available
Form 1 CoC Applicants - Private Sector	Form and Instruction	New	Repair queued
Attach 2 Supplemental Document for the CoC SSA.doc	Supplementary Document	Uploaded 2013-11-12	Repair queued
support_stmt_A coc online app system November FINAL 11.13.2013.doc	Supporting Statement A	Uploaded 2013-11-22	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
209604	CoC Applicants- Federal	Form and Instruction	New
209603	CoC Applicants- Small Business	Form and Instruction	New
209602	CoC Applicants- State and Local	Form and Instruction	New
209601	CoC Applicants - Private Sector	Form and Instruction	New

ICR Details

OMB Control No: 0925-0689	ICR Reference No: 201312-0925-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No: 20936
Title: Electronic Application for NIH Certificates of Confidentialty (CoC E-application System)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/02/2014
	Date Received in OIRA: 12/06/2013
Terms of Clearance:

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

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Abstract: The recruitment of human research subjects into NIH funded studies is critical to the success of the agency's mission to enhance health, lengthen life, and reduce the burdens of illness and disability. However, human research subjects are often concerned about the potential negative consequences of access to their research data by individuals outside the research team. This situation can make it difficult to recruit subjects for research projects on sensitive topics. Recognizing this problem, in 1970, Congress enacted legislation to permit the Department of Health and Human Services (DHHS) to issue Certificates of Confidentiality (CoCs) to authorize covered researchers to protect the privacy of research subjects by withholding their names and identifying characteristics from those not connected with the research. The legislation was initially limited to research on the use and effect of drugs. Since then, the scope of the CoC legislation has been expanded several times, most recently in 1988. 1997, DHHS delegated the authority to issue CoCs to NIH and the other DHHS agencies that fund research. The Director of NIH further delegated this authority within NIH to the individual NIH Institutes and Centers (ICs). NIH's Office of Extramural Research (OER) is responsible for coordinating this activity across NIH. The information to be collected via the electronic CoC application system will be used by the NIH IC's to determine eligibility for a CoC and to help create the actual Certificate that will be issued to the requesting organization. Additionally, the system will assist NIH staff with the administrative management of requests, for example, by tracking progress of requests and key dates (receipt of request, issuance of CoC, expiration dates. Additionally, OER will use the data from the system for routine internal program monitoring for NIH.

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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:
	78 FR 25090	04/29/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 69857	11/21/2013
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 - Private Sector	1	CoC Online Application (Screenshots)
CoC Applicants- State and Local	1	CoC On-line Application ( Screenshots)
CoC Applicants- Small Business	1	CoC On-line Application (Screenshots)
CoC Applicants- Federal	1	CoC On-line Application (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	1,000	0	0	1,000	0	0
Annual Time Burden (Hours)	1,500	0	0	1,500	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: This is a new data collection.

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Annual Cost to Federal Government: $52,062

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: 12/06/2013

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