View Information Collection Request (ICR) Package
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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:
201912-0925-001
Status:
Historical Active
Previous ICR Reference No:
201610-0925-002
Agency/Subagency:
HHS/NIH
Agency Tracking No:
20936
Title:
Electronic Application for NIH Certificates of Confidentialty (CoC E-application System)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
02/07/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/23/2019
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2023
36 Months From Approved
02/29/2020
Responses
529
0
1,300
Time Burden (Hours)
794
0
1,951
Cost Burden (Dollars)
0
0
0
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.
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:
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
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
CoC Applicants - Federal
1
NIH Certificates of Confidentiality Request Form Screenshots
CoC Applicants - Small Business
1
NIH Certificate of Confidentiality Request Form Screenshot
CoC Applicants - Small business
1
OEP CoC Application
CoC Applicants - State/local
1
NIH Certificates of Confidentiality Request Form Screenshots
CoC Applicants -Federal
1
OEP CoC Application
CoC Applicants Private
1
OEP CoC Application
CoC Applicants- State/local
1
OEP CoC Application
CoC Applications - Private
1
NIH Certificates of Confidentiality Request Form Screenshot
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
1,300
0
-771
0
0
Annual Time Burden (Hours)
794
1,951
0
-1,157
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
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.
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
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:
12/23/2019
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