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:
0925-0764
ICR Reference No:
202402-0925-002
Status:
Active
Previous ICR Reference No:
202210-0925-009
Agency/Subagency:
HHS/NIH
Agency Tracking No:
Title:
Application and Impact of Online Clinical Research Training Programs on Healthcare Professionals in Industry, Academia, and Clinical Research, Office of Clinical Research, OD, NIH
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:
07/31/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/25/2024
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2027
36 Months From Approved
02/28/2026
Responses
21,290
0
22,040
Time Burden (Hours)
1,774
0
3,674
Cost Burden (Dollars)
0
0
0
Abstract:
The request for a revision under the existing clearance number 0925-0764 for information collection will continue to allow the assessment of the long-term impact and outcomes of clinical research training programs provided by the Office of Clinical Research Education and Collaboration Outreach (OCRECO), located in the NIH Office of Intramural Research on an annual basis. This revision request will also allow for the addition of a new clinical research training course to be delivered online through the same online learning management system as the other courses. The clinical research training programs include: the Introduction to the Principles and Practice of Clinical Research and Principles of Clinical Pharmacology, Sabbatical in Clinical Research Management, the NIH Summer Course in Clinical and Translational Research, and the new course, the Ethical and Regulatory Aspects of Clinical Research Course (Asynchronous/Online). Please note that the Office of Clinical Research Education and Collaboration Outreach (OCRECO) was formerly titled the Office of Clinical Research, until March 2023 with the change of office leadership.
Authorizing Statute(s):
EO: EO 12862 Name/Subject of EO: Setting Customer Service Standards
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:
88 FR 49472
07/31/2023
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 44999
05/22/2024
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
18
IC Title
Form No.
Form Name
Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) Course
1
Survey
IPPCR Final Course Evaluation (General Public)
1
Evaluation
IPPCR Final Course Evaluation (Healthcare Professionals)
1
Evaluation
IPPCR Final Course Evaluation (Students)
1
Evaluation
IPPCR Lecture Evaluation (General Public)
1
Evaluation
IPPCR Lecture Evaluation (Health Care Professionals)
1
Evaluation
IPPCR Lecture Evaluation (Students)
1
Evaluation
NIH Summer Course in Clinical and Translational Research Course Evaluation
1
Survey
OCR Learning Portal Registration (General Public)
1
Registration
OCR Learning Portal Registration (Health Professionals)
1
Registration
OCR Learning Portal Registration (Students)
1
Registration
PCP Final Course Evaluation (General Public)
1
Survey
PCP Final Course Evaluation (Healthcare Professionals)
1
Survey
PCP Final Course Evaluation (Students)
1
Survey
PCP Lecture Evaluation (General Public)
1
Survey
PCP Lecture Evaluation (Healthcare Professionals)
1
Survey
PCP Lecture Evaluation (Students)
1
Survey
Sabbatical in Clinical Research Management Course Evaluation (Healthcare Professionals)
1
Survey
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
21,290
22,040
0
-750
0
0
Annual Time Burden (Hours)
1,774
3,674
0
-1,900
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:
Changing Forms
Short Statement:
Survey instruments included in this revision request have revised survey questions as well as a new survey altogether to account for the addition of a new clinical research training course, the Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) course. The total estimated number of respondents per year to all surveys included in this request is less than the previous number cited in the extension request (22,040 respondents) based on 2023 program data. The maximum time allotment for completion of each survey was also changed from 10 minutes to 5 minutes. The estimated total burden hours requested in this current revision is 1,774 as opposed to the estimation of 3,674 burden hours in the previous extension request.
Annual Cost to Federal Government:
$52,165
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?
No
Agency Contact:
Mikia Currie 3014350941
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:
06/25/2024
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