View Information Collection Request (ICR) Package
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Certification
View Information Collection (IC) List
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
Authorizing Statute(s):
US Code:
42 USC 241(d)
Name of Law: US Public Health Service Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
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 - Small business
1
OEP CoC Application
CoC Applicants -Federal
1
OEP CoC Application
CoC Applicants Private
1
OEP CoC Application
CoC Applicants- Federal
1
CoC On-line Application (Screenshots)
CoC Applicants- Small Business
1
CoC On-line Application (Screenshots)
CoC Applicants- State and Local
1
CoC On-line Application ( Screenshots)
CoC Applicants- State/local
1
OEP CoC Application
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.
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
Agency Contact:
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov
Common Form ICR:
No
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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