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	Modified
Form 21 Trainee Diversity Report (part of Final RPPR) Form	Modified
Form 13 Data Tables (Part of Final RPPR) Form and Instruction	Modified
Form 23 PHS Human Subjects and Clinical Trial Information (Part of Final RPPR, includes inclusion/enrollment) Form and Instruction	Modified
Form 13 Final RPPR - Core Data Form and Instruction	Modified
Form 22 PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report) Form and Instruction	Modified
Form 27 SBIR/STTR Life Cycle Certification Form and Instruction	Modified
Form 26 SBIR/STTR Phase II Final Progress Report Form and Instruction	Removed
Form 21 Trainee Diversity Report (part of RPPR) Form and Instruction	Modified
Form 20 PHS 3734 Form and Instruction	Modified
Form 19 Publication Reporting Form and Instruction	Modified
Form 18 Data Tables (Part of RPPR) Form and Instruction	Modified
Form 13 Biosketch (part of RPPR) Form	Modified
Form 17 RPPR Core Data Form	Modified
Form 11 PHS 2590 Form	Modified
Form 10 PHS 2271 Form and Instruction	Modified
Form 4 iEdison Form and Instruction	Modified
Form 3 PHS 568 Form and Instruction	Modified
Form 2 PHS 6031-1 Form and Instruction	Modified
pub 30 day 0002 2021-16849.pdf Supplementary Document	2021-08-11
Supporting Statement A for 0925-0002_final.docx Supporting Statement A	2021-08-11
Att D NIH Other Support and In-Kind_Instructions_6-28-2021.docx Supplementary Document	2021-08-11
Att C NIH Other Support Format Page_6-28-2021.docx Supplementary Document	2021-08-11
Attachment 22 HHS Approved PIA - Electronic Research Administration 7152019.docx Supplementary Document	2019-12-27
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

IC Document Collections

IC ID	Document Title	Status
225309	PHS 416-7 Form and Instruction	Modified
225128	Trainee Diversity Report (part of Final RPPR) Form	Modified
225116	Data Tables (Part of Final RPPR) Form and Instruction	Modified
225115	PHS Human Subjects and Clinical Trial Information (Part of Final RPPR, includes inclusion/enrollment) Form and Instruction	Modified
225114	Final RPPR - Core Data Form and Instruction	Modified
225112	PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report) Form and Instruction	Modified
217452	SBIR/STTR Life Cycle Certification Form and Instruction	Modified
217451	SBIR/STTR Phase II Final Progress Report Form and Instruction	Removed
217449	Trainee Diversity Report (part of RPPR) Form and Instruction	Modified
217440	PHS 3734 Form and Instruction	Modified
217439	Publication Reporting Form and Instruction	Modified
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	Modified
217416	iEdison Form and Instruction	Modified
217415	PHS 568 Form and Instruction	Modified
217413	PHS 6031-1 Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0002	ICR Reference No: 202108-0925-002
Status: Received in OIRA	Previous ICR Reference No: 202012-0925-002
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	Date Submitted to OIRA: 08/12/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2023
Responses	411,699	413,029
Time Burden (Hours)	532,249	533,579
Cost Burden (Dollars)	0	0

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Abstract: The National Institutes of Health (NIH) and other Public Health Service (PHS) grantees are required to submit interim and final progress reports and other post-award documents associated with the monitoring, oversight, and closeout of an award. 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 February 28, 2023) and the changes to the collection here are related. This collection is being revised to omit the Inclusion Enrollment Report form, which is being converted to a Common form to include the Department of Defense (DoD). The Inclusion Enrollment Report is used for all progress reporting involving NIH-defined clinical research. This form is used to report both planned and cumulative (or actual) enrollment, and describes the sex/gender, race, and ethnicity of the study participants. Starting in January 2022, NIH will require applicants and recipients to provide their Unique Entity Identifier (UEI) instead of the Data Universal Number System (DUNS) number. Also, the progress reporting forms will be updated to align with the Grants.gov updated Country and State lists.

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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:
	86 FR 18994	04/12/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 43258	08/06/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 18

IC Title	Form No.	Form Name
PHS 2271	10, 9	Post-Award eRA Commons Screen Shots ,   PHS 2271
PHS 2590	11, 16, 14, 12, 15, 13, 15	PHS 2590 Forms ,   Trainee Diversity Report ,   General Non-Fellowship Biographical Sketch Format Page ,   Fellowship Applicant Biographical Sketch Format Page ,   Fellowship Applicant Biographical Sketch Postdoctoral Sample ,   Fellowship Applicant Biographical Sketch Predoctoral Sample ,   Revised - Fellowship Applicant Biographical Sketch Format Page
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 Non-Fellowship 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
Final RPPR - Core Data	13	Research Performance Progress Report (RPPR) and Final RPPR
PHS 3734	20	Attachment 18 PHS 374
PHS 416-7	28, 1	National Research Service Award Termination Notice ,   Post Award eRA Commons Screen Shots xTrain, xTRACT
PHS 568	3	HHS 568
PHS 6031-1	2	PHS 6031-1 FORMS-G
PHS Human Subjects and Clinical Trial Information (Part of Final RPPR, includes inclusion/enrollment)	23, 24, 22	PHS Human Subjects and Clinical Trial Information- Inclusion Enrollment Report ,   PHS Human Subjects and Clinical Trial Information Sections 1-6 ,   PHS Human Subjects and Clinical Trial Information Landing Page
PHS Human Subjects and Clinical Trial Information (Part of RPPR, includes inclusion enrollment report)	24, 23, 22	Landing Page ,   HSCT Sections 1-6 ,   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	28, 27	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

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ICR Summary of Burden

	Total Request	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	411,699	413,029	0	-1,330	0	0
Annual Time Burden (Hours)	532,249	533,579	0	-1,330	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Changes made reflect an adjustment in burden hours. A decrease of 1,330 burden hours is due to the SBIR/STTR Final Progress Report no longer being accepted. Overall, the burden hour estimates for other PHS forms did not change.

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Annual Cost to Federal Government: $238,382

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

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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: 08/12/2021

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