OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

PHS Research Performance Progress Report and Other Post-award Reporting (OD)

ICR 201701-0925-004 · OMB 0925-0002 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form 1 PHS 416-7 Form and Instruction Removed Repair queued
Form 1 PHS 416-7 Form and Instruction New Available
Form 21 Trainee Diversity Report (part of Final RPPR) Form New Repair queued
Form 13 Data Tables (Part of Final RPPR) Form New Available
Form 22 PHS Human Subjects and Clinical Trial Information (Part of Final RPPR, includes inclusion/enrollment) Form New Repair queued
Form 13 Final RPPR - Core Data Form New Repair queued
Form 22 PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report) Form New Repair queued
Form 27 SBIR/STTR Life Cycle Certification Form and Instruction Modified Repair queued
Form 26 SBIR/STTR Phase II Final Progress Report Form and Instruction Modified Repair queued
Form 25 Final Progress Report Form and Instruction Modified Repair queued
Form 21 Trainee Diversity Report (part of RPPR) Form and Instruction Modified Repair queued
Form 21 PHS Inclusion Enrollment Report Form and Instruction Removed Repair queued
Form 20 PHS 374 Form and Instruction Modified Repair queued
Form 19 Publication Reporting Form and Instruction Unchanged Repair queued
Form 18 Data Tables (Part of RPPR) Form and Instruction Modified Available
Form 13 Biosketch (part of RPPR) Form Modified Repair queued
Form 17 RPPR Core Data Form Modified Repair queued
Form 14 PHS 2590 Form Modified Repair queued
Form 10 PHS 2271 Form and Instruction Unchanged Available
Form 4 iEdison Form and Instruction Unchanged Available
Form 3 PHS 568 Form and Instruction Unchanged Repair queued
Form 2 PHS 6031-1 Form and Instruction Unchanged Available
FRN 0002 2017-02471 (1).pdf Supplementary Document Uploaded 2017-02-07 Repair queued
Attachment 22 Privacy Impact Assessment.pdf Supplementary Document Uploaded 2017-01-25 Repair queued
Attachment 1 Former, Revised, and New Content of Information Collections.docx Supplementary Document Uploaded 2017-01-25 Repair queued
Attachment 21 Prior Approval Screen Shots.docx Supplementary Document Uploaded 2017-01-25 Repair queued
Attachment 2 CFDA.xlsx Supplementary Document Uploaded 2017-01-25 Repair queued
Supporting Statement A for 0925-0002.docx Supporting Statement A Uploaded 2017-01-25 Available
IC Document Collections
IC IDCollectionTypeStatusForm
7244 PHS 416-7 Form and Instruction Removed
225309 PHS 416-7 Form and Instruction New
225128 Trainee Diversity Report (part of Final RPPR) Form New
225116 Data Tables (Part of Final RPPR) Form New
225115 PHS Human Subjects and Clinical Trial Information (Part of Final RPPR, includes inclusion/enrollment) Form New
225114 Final RPPR - Core Data Form New
225112 PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report) Form New
217452 SBIR/STTR Life Cycle Certification Form and Instruction Modified
217451 SBIR/STTR Phase II Final Progress Report Form and Instruction Modified
217450 Final Progress Report Form and Instruction Modified
217449 Trainee Diversity Report (part of RPPR) Form and Instruction Modified
217448 PHS Inclusion Enrollment Report Form and Instruction Removed
217440 PHS 374 Form and Instruction Modified
217439 Publication Reporting Form and Instruction Unchanged
217430 Data Tables (Part of RPPR) Form and Instruction Modified
217420 Biosketch (part of RPPR) Form Modified
217419 RPPR Core Data Form Modified
217418 PHS 2590 Form Modified
217417 PHS 2271 Form and Instruction Unchanged
217416 iEdison Form and Instruction Unchanged
217415 PHS 568 Form and Instruction Unchanged
217413 PHS 6031-1 Form and Instruction Unchanged
ICR Details
0925-0002 201701-0925-004
Historical Active 201507-0925-006
HHS/NIH 20860
PHS Research Performance Progress Report and Other Post-award Reporting (OD)
Revision of a currently approved collection   No
Regular
Approved without change 03/15/2017
Retrieve Notice of Action (NOA) 02/08/2017
  Inventory as of this Action Requested Previously Approved
03/31/2020 36 Months From Approved 10/31/2018
220,983 0 203,394
519,408 0 307,116
0 0 0
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.
US Code: 42 USC 288 Name of Law: National Research Act
  
None
Not associated with rulemaking
  81 FR 76371 11/02/2016
82 FR 9573 02/07/2017
No
20
IC Title Form No. Form Name
PHS 568 3 HHS 568
Final RPPR - Core Data 13 Research Performance Progress Report (RPPR) and Final RPPR Screenshots
Data Tables (Part of RPPR) 18 Introducation to the Data Tables
Publication Reporting 19 Attachment 11 MY BIB screenshot
PHS 6031-1 2 PHS 6031-1
PHS Inclusion Enrollment Report 21 PHS Inclusion Enrollment Report
PHS 374 20 Attachment 18 PHS 374
Data Tables (Part of Final RPPR) 13 Research Performance Progress Report (RPPR) and Final RPPR Screenshots
Trainee Diversity Report (part of RPPR) 21 Attachment 7 Trainee Diversity Report
Final Progress Report 25 Attachment 17 Final Progress Report
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
PHS 2271 9, 10 Post-Award eRA Commons Screen Shots ,   PHS 2271
PHS 2590 11, 16, 14, 12, 15, 13 Fellowship Applicant Biographical Sketch Format Page ,   Fellowship Applicant Biographical Sketch Postdoctoral Sample ,   Fellowship Applicant Biographical Sketch Predoctoral Sample ,   PHS 2590 Forms ,   Trainee Diversity Report ,   General Biographical Sketch Format Page
Biosketch (part of RPPR) 14, 13 General Biographical Sketch Format Page ,   Fellowship Applicant Biographical Sketch Format Page
SBIR/STTR Phase II Final Progress Report 26 Final Progress Report
SBIR/STTR Life Cycle Certification 27, 28 SBIR Life Cycle Certification ,   STTR Life Cycle Certification
Trainee Diversity Report (part of Final RPPR) 21 Trainee Diversity Report
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 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 416-7 28, 1 National Research Service Award Termination Notice ,   Post-Award eRA Commons Screen Shots xTrain-2
RPPR Core Data 17 Research Performance Progress Report (RPPR) and Final RPPR Screenshots
PHS 416-7 1, 27 PHS 416-7: Termination Notice for National Research Service Award ,   Post-Award eRA Commons Screen Shots xTrain
  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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.
$222,054
No
No
No
No
No
Uncollected
Tawanda Abdelmouti 240 276-5530 [email protected]
  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
02/08/2017