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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:
0925-0002
ICR Reference No:
201701-0925-004
Status:
Historical Active
Previous ICR Reference No:
201507-0925-006
Agency/Subagency:
HHS/NIH
Agency Tracking No:
20860
Title:
PHS Research Performance Progress Report and Other Post-award Reporting (OD)
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:
03/15/2017
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/08/2017
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2020
36 Months From Approved
10/31/2018
Responses
220,983
0
203,394
Time Burden (Hours)
519,408
0
307,116
Cost Burden (Dollars)
0
0
0
Abstract:
This 0925-0002 revision submission represents a collection of post-award reporting requirements previously collected under 0925-0002. Pre-award reporting requirements are simultaneously consolidated under 0925–0001 (expiration October 31, 2018) and the changes to the collection here are related. Clinical trials are complex and challenging research activities. Oversight systems and tools are critical for the NIH to ensure participant safety, data integrity, and accountability of the use of public funds. The NIH has been engaged in a multi-year effort to examine how clinical trials are supported and the level of oversight needed.
Authorizing Statute(s):
US Code:
42 USC 288
Name of Law: National Research 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 76371
11/02/2016
30-day Notice:
Federal Register Citation:
Citation Date:
82 FR 9573
02/07/2017
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
20
IC Title
Form No.
Form Name
PHS 2271
9, 10
PHS 2271
,
Post-Award eRA Commons Screen Shots
PHS 2590
11, 16, 14, 12, 15, 13
PHS 2590 Forms
,
Trainee Diversity Report
,
General Biographical Sketch Format Page
,
Fellowship Applicant Biographical Sketch Format Page
,
Fellowship Applicant Biographical Sketch Postdoctoral Sample
,
Fellowship Applicant Biographical Sketch Predoctoral Sample
iEdison
4, 5, 6, 7, 8
iEdison Burden Statement
,
iEdison Screen Shot Manage Utilization Report
,
iEdison screen shot Invention Disclosure Report
,
iEdison screen shot Patent Record
,
iEdison screen shot Registration Request Form
Biosketch (part of RPPR)
14, 13
General Biographical Sketch Format Page
,
Fellowship Applicant Biographical Sketch Format Page
Data Tables (Part of RPPR)
18
Introducation to the Data Tables
Data Tables (Part of Final RPPR)
13
Research Performance Progress Report (RPPR) and Final RPPR Screenshots
Final Progress Report
25
Attachment 17 Final Progress Report
Final RPPR - Core Data
13
Research Performance Progress Report (RPPR) and Final RPPR Screenshots
PHS 374
20
Attachment 18 PHS 374
PHS 416-7
28, 1
National Research Service Award Termination Notice
,
Post-Award eRA Commons Screen Shots xTrain-2
PHS 416-7
1, 27
PHS 416-7: Termination Notice for National Research Service Award
,
Post-Award eRA Commons Screen Shots xTrain
PHS 568
3
HHS 568
PHS 6031-1
2
PHS 6031-1
PHS Human Subjects and Clinical Trial Information (Part of Final RPPR, includes inclusion/enrollment)
22, 24, 23
PHS Human Subjects and Clinical Trial Information - Landing Page
,
PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report
,
PHS Human Subjects and Clinical Trial Information - Sections 1-5
PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report)
24, 22, 23
PHS Human Subjects and Clinical Trial Information - Landing Page
,
PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report
,
PHS Human Subjects and Clinical Trial Information - Sections 1-5
PHS Inclusion Enrollment Report
21
PHS Inclusion Enrollment Report
Publication Reporting
19
Attachment 11 MY BIB screenshot
RPPR Core Data
17
Research Performance Progress Report (RPPR) and Final RPPR Screenshots
SBIR/STTR Life Cycle Certification
27, 28
SBIR Life Cycle Certification
,
STTR Life Cycle Certification
SBIR/STTR Phase II Final Progress Report
26
Final Progress Report
Trainee Diversity Report (part of Final RPPR)
21
Trainee Diversity Report
Trainee Diversity Report (part of RPPR)
21
Attachment 7 Trainee Diversity Report
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
220,983
203,394
0
30,169
-12,580
0
Annual Time Burden (Hours)
519,408
307,116
0
218,582
-6,290
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 submission represents several program changes; previous estimated total burden hours for 0925-0002 were 307,116; current estimated total burden hours for 0925-0002 is 519,408. This represents an increase of 212,292 hours since the last approval. This increase is largely due to addition of clinical trial data collection within the RPPR and Final RPPR, as well as the collection of the Final RPPR itself.
Annual Cost to Federal Government:
$222,054
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:
02/08/2017
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