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:
0925-0698
ICR Reference No:
202006-0925-001
Status:
Historical Active
Previous ICR Reference No:
201705-0925-008
Agency/Subagency:
HHS/NIH
Agency Tracking No:
21541
Title:
Application Process for Clinical Research Training and Medical Education at the Clinical Center and its impact on Course and Training Program Enrollment and Effectiveness (CC)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
08/17/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/30/2020
Terms of Clearance:
Approved with the understanding that discontinued activities in this ICR were moved to OMB Control Number 0925-0764.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2023
36 Months From Approved
08/31/2020
Responses
1,000
0
12,448
Time Burden (Hours)
333
0
4,148
Cost Burden (Dollars)
0
0
0
Abstract:
The existing information collection proposed for revision allows on-going assessment of the eligibility and qualifications of candidates applying for participation in clinical research training programs provided by the Office of Clinical Research Training and Medical Education located in the NIH Clinical Center (CC) over a ten year follow-up period.
Authorizing Statute(s):
US Code:
42 USC 241
Name of Law: Public Health 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:
85 FR 21255
04/16/2020
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 39199
06/30/2020
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Bioethics
10
Bioethics Fellowship Program
Bioethics Fellowship Program
5
Bioethics Fellowship Program
Clinical Electives Program (CEP
1
Clinical Electives Program
Clinical Research Course
11
Clinical Research Training
Graduate Medical Education (GME)
2
Graduated Medical Education
IPPCR
5
IPPCR
Medical Research Scholars Program (MSRP)
3
Medical Research Scholars Program
NIH-Duke
2
NIH-Duke
PCP
3
PCP
PhD Summer Course
4
PhD Summer Course
Resident Elective Program (REP)
4
Resident Electives Program
Sabbatical
6
Sabbatical in Clinical Research Management
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
12,448
0
-11,448
0
0
Annual Time Burden (Hours)
333
4,148
0
-3,815
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:
This is an ongoing project with a request for revision. The request for revision includes the discontinuation of program applications for Introduction to the Principles and Practice of Clinical Research (IPPCR), NIH-Duke Training Program in Clinical Research (NIH-DUKE), Ph.D. Student Summer Course in Clinical and Translational Research, Principles of Clinical Pharmacology Course (PCP), Sabbatical in Clinical Research Management, and Clinical Research Training On-Line Course for Principal Investigators a these training programs initially managed by OCRTME have transitioned to the NIH Office of Clinical Research. With the decrease of training program applications that will be continued under this collection, both the estimated number of survey respondents will decrease from 12,448 to 1,000 respondents and the estimated total burden will decrease from 4148 to 333 hours, respectively.
Annual Cost to Federal Government:
$78,769
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:
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:
06/30/2020
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