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

Forms and Documents

Document Name	Status
Form 1 PHS 416-7 Form and Instruction	Unchanged
Form 21 Trainee Diversity Report (part of Final RPPR) Form	Unchanged
Form 13 Data Tables (Part of Final RPPR) Form	Unchanged
Form 22 PHS Human Subjects and Clinical Trial Information (Part of Final RPPR, includes inclusion/enrollment) Form	Unchanged
Form 13 Final RPPR - Core Data Form	Unchanged
Form 22 PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report) Form	Unchanged
Form 27 SBIR/STTR Life Cycle Certification Form and Instruction	Unchanged
Form 26 SBIR/STTR Phase II Final Progress Report Form and Instruction	Unchanged
Form 25 Final Progress Report Form and Instruction	Unchanged
Form 21 Trainee Diversity Report (part of RPPR) Form and Instruction	Unchanged
Form 20 PHS 374 Form and Instruction	Unchanged
Form 19 Publication Reporting Form and Instruction	Unchanged
Form 18 Data Tables (Part of RPPR) Form and Instruction	Unchanged
Form 13 Biosketch (part of RPPR) Form	Unchanged
Form 17 RPPR Core Data Form	Unchanged
Form 11 PHS 2590 Form	Unchanged
Form 9 PHS 2271 Form and Instruction	Unchanged
Form 4 iEdison Form and Instruction	Unchanged
Form 3 PHS 568 Form and Instruction	Unchanged
Form 2 PHS 6031-1 Form and Instruction	Unchanged
Attachment A - 5F and 5B PHS Human Subjects and Clinical Trial Information - Sections 1-5.pdf Supplementary Document	2017-08-24
Attachment A - 5F and 5B PHS Human Subjects and Clinical Trial Information - Landing Page.pdf Supplementary Document	2017-08-24
OMB Change Request Memo to OMB - 0925-0001 - August 2017.docx Justification for No Material/Nonsubstantive Change	2017-08-24
FRN 0002 2017-02471 (1).pdf Supplementary Document	2017-02-07
Attachment 22 Privacy Impact Assessment.pdf Supplementary Document	2017-01-25
Attachment 1 Former, Revised, and New Content of Information Collections.docx Supplementary Document	2017-01-25
Attachment 21 Prior Approval Screen Shots.docx Supplementary Document	2017-01-25
Attachment 2 CFDA.xlsx Supplementary Document	2017-01-25
Supporting Statement A for 0925-0002.docx Supporting Statement A	2017-01-25

IC Document Collections

IC ID	Document Title	Status
225309	PHS 416-7 Form and Instruction	Unchanged
225128	Trainee Diversity Report (part of Final RPPR) Form	Unchanged
225116	Data Tables (Part of Final RPPR) Form	Unchanged
225115	PHS Human Subjects and Clinical Trial Information (Part of Final RPPR, includes inclusion/enrollment) Form	Unchanged
225114	Final RPPR - Core Data Form	Unchanged
225112	PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report) Form	Unchanged
217452	SBIR/STTR Life Cycle Certification Form and Instruction	Unchanged
217451	SBIR/STTR Phase II Final Progress Report Form and Instruction	Unchanged
217450	Final Progress Report Form and Instruction	Unchanged
217449	Trainee Diversity Report (part of RPPR) Form and Instruction	Unchanged
217440	PHS 374 Form and Instruction	Unchanged
217439	Publication Reporting Form and Instruction	Unchanged
217430	Data Tables (Part of RPPR) Form and Instruction	Unchanged
217420	Biosketch (part of RPPR) Form	Unchanged
217419	RPPR Core Data Form	Unchanged
217418	PHS 2590 Form	Unchanged
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

OMB Control No: 0925-0002	ICR Reference No: 201708-0925-003
Status: Historical Active	Previous ICR Reference No: 201701-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No: 20860
Title: PHS Research Performance Progress Report and Other Post-award Reporting (OD)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/21/2017
	Date Received in OIRA: 08/28/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2020	03/31/2020	03/31/2020
Responses	220,983	0	220,983
Time Burden (Hours)	519,408	0	519,408
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): US Code: 42 USC 288 Name of Law: National Research Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 20

IC Title	Form No.	Form Name
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)	23, 24, 22	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 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 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	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
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
PHS 6031-1	2	PHS 6031-1

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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	220,983	0	0	0	0
Annual Time Burden (Hours)	519,408	519,408	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

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.

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Annual Cost to Federal Government: $222,054

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

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Common Form ICR:  No

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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: 08/28/2017

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