PHS Applications and Pre-award Related Reporting (OD)

Forms and Documents

Document	Type	Status	Availability
Form 1 PHS 398 Paper	Form	Unchanged	Available
Form 16 Fellowship Electronic PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	Form and Instruction	Unchanged	Available
Form 17 398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	Form and Instruction	Unchanged	Repair queued
Form 29 PHS 416-5	Form and Instruction	Unchanged	Repair queued
Form 27 SBIR/STTR Funding Agreement Certification	Form and Instruction	Unchanged	Repair queued
Form 26 VCOC Certification	Form and Instruction	Unchanged	Repair queued
Form 1 PHS 6031	Form and Instruction	Modified	Available
Form 19 416-1	Form and Instruction	Unchanged	Repair queued
Form 15 Biosketch (Fellowship)	Form and Instruction	Unchanged	Repair queued
Form 14 PHS Assignment Request Form	Form	Unchanged	Repair queued
Form 13 PHS Fellowship Supplemental Form (includes F reference letters)	Form	Modified	Repair queued
Form 12 Biosketch (424 Electronic)	Form	Unchanged	Repair queued
Form 11 PHS 398 Career Development Award Supplemental Form	Form	Unchanged	Repair queued
Form 10 Data Tables	Form and Instruction	Unchanged	Available
Form 9 PHS 398 Research Training Program Plan	Form	Unchanged	Repair queued
Form 8 PHS 398 Research Plan	Form	Unchanged	Available
Form 7 PHS 398 Training Subaward Budget Attachment(s) Form	Form	Unchanged	Available
Form 6 PHS 398 Training Budget	Form	Unchanged	Available
Form 5 PHS 398 Modular Budget	Form and Instruction	Unchanged	Repair queued
Form 4 PHS 398 Cover Page Supplement	Form	Unchanged	Available
Form 3 PHS Assignment Request Form	Form	Unchanged	Repair queued
Attachment 15_eRA Commons Profile Data Elements (ORCID ID)_updated 05-27-2020.xlsx	Supplementary Document	Uploaded 2020-06-30	Repair queued
phs6031_6-15-2020_redline changes.docx	Supplementary Document	Uploaded 2020-06-30	Repair queued
0001 OMB Change Request Memo 62020.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-06-30	Repair queued
PHS 6031_04-27-2020.pdf	Supplementary Document	Uploaded 2020-04-27	Repair queued
OMB Change Request Memo PHS 6031.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-04-27	Available
OMB Change Request Memo Training Tables.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-03-23	Repair queued
datatables_intro_JS_3-13-2020.docx	Supplementary Document	Uploaded 2020-03-23	Available
Undergraduate_Training_Tables_JS_3-12-2020.docx	Supplementary Document	Uploaded 2020-03-23	Repair queued
Consolidated_Training_Tables_JS_3-12-2020.docx	Supplementary Document	Uploaded 2020-03-23	Available
30-day 0001.pdf	Supplementary Document	Uploaded 2019-12-30	Repair queued
rev Supporting Statement A for 0925-0001 feb2020.docx	Supporting Statement A	Uploaded 2020-02-05	Repair queued
Attachment 14 supplemental grant application -instructions-forms-e.pdf	Supplementary Document	Uploaded 2019-12-27	Repair queued
Attachment 20 0001 60-day Comment Tracking Log FINAL.doc	Supplementary Document	Uploaded 2019-12-27	Available
Attachment 19 HHS Approved PIA - Electronic Research Administration 7152019.docx	Supplementary Document	Uploaded 2019-12-27	Repair queued
Personal Profile - eRA Screen Shot.docx	Supplementary Document	Uploaded 2017-05-25	Repair queued
eRA Commons Profile Data Elements (ORCID ID).xlsx	Supplementary Document	Uploaded 2017-05-25	Available
Attachment 18 Prior Approval Screen Shots.docx	Supplementary Document	Uploaded 2017-01-26	Available
Attachment 2 CFDA.xlsx	Supplementary Document	Uploaded 2017-01-26	Repair queued
Attachment 1 Former, Revised, and New Content of Information Collections.docx	Supplementary Document	Uploaded 2017-01-25	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
37814	PHS 398 Paper	Form	Unchanged
225109	Fellowship Electronic PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	Form and Instruction	Unchanged
225108	398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	Form and Instruction	Unchanged
217591	PHS 416-5	Form and Instruction	Unchanged
217570	SBIR/STTR Funding Agreement Certification	Form and Instruction	Unchanged
217569	VCOC Certification	Form and Instruction	Unchanged
217568	PHS 6031	Form and Instruction	Modified
217567	416-1	Form and Instruction	Unchanged
217566	Biosketch (Fellowship)	Form and Instruction	Unchanged
217564	PHS Assignment Request Form	Form	Unchanged
217563	PHS Fellowship Supplemental Form (includes F reference letters)	Form	Modified
217561	Biosketch (424 Electronic)	Form	Unchanged
217560	PHS 398 Career Development Award Supplemental Form	Form	Unchanged
217559	Data Tables	Form and Instruction	Unchanged
217558	PHS 398 Research Training Program Plan	Form	Unchanged
217557	PHS 398 Research Plan	Form	Unchanged
217556	PHS 398 Training Subaward Budget Attachment(s) Form	Form	Unchanged
217555	PHS 398 Training Budget	Form	Unchanged
202980	PHS 398 Modular Budget	Form and Instruction	Unchanged
202963	PHS 398 Cover Page Supplement	Form	Unchanged
202959	PHS Assignment Request Form	Form	Unchanged

ICR Details

OMB Control No: 0925-0001	ICR Reference No: 202006-0925-002
Status: Historical Active	Previous ICR Reference No: 202004-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No: 19797
Title: PHS Applications and Pre-award Related 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: 07/30/2020
	Date Received in OIRA: 06/30/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	02/28/2023	02/28/2023
Responses	421,777	0	421,777
Time Burden (Hours)	2,150,389	0	2,150,389
Cost Burden (Dollars)	0	0	0

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Abstract: This 0925-0001 revision submission consolidates application and other related pre-award reporting requirements previously collected under 0925-0001. 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 also continued to update requirements to align with enhancements and changes to key policies, including engaging in defining application requirements to address Congressional and Department of Health and Human Services mandates related to human fetal tissue research.

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Authorizing Statute(s): US Code: 42 USC 288 Name of Law: Public Health Serive Act
   US Code: 42 USC 286 Name of Law: Public Health Service Act
   US Code: 42 USC 216 Name of Law: Public health Service Act
   US Code: 42 USC 300 Name of Law: Public Health Service Act
   US Code: 42 USC 285 Name of Law: public Health Serice Act
   US Code: 42 USC 241 Name of Law: Public Health Service
  

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:
	84 FR 14956	04/12/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 71967	12/30/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 21

IC Title	Form No.	Form Name
Data Tables	10	Introduction to the Data Tables
PHS Fellowship Supplemental Form (includes F reference letters)	15, 13	PHS Fellowship Supplemental Form ,   eRA Commons Profile Data Elements
Biosketch (424 Electronic)	12	General Biographical Sketch Format Page
PHS 6031	1	PHS 6031
PHS 398 Career Development Award Supplemental Form	11	PHS 398 Career Development Award Supplemental Form
PHS 398 Research Training Program Plan	9	PHS 398 Research Training Program Plan Form
Biosketch (Fellowship)	15	Fellowship Applicant Biographical Sketch Format Page
416-1	19, 20, 21, 22, 24, 23	Attachment 7B PHS 416-1 Face Page 1 ,   Attachment 7C PHS 416-1 Face Page 2 ,   Attachment 7D PHS 416-1 Face Page 3 ,   Attachment 7E PHS 416-1 Face Page 4 ,   Attachment 7F PHS 416-1 Checklist Form Page ,   Attachment 7G PHS 416-1 Continuation Page
VCOC Certification	26	VCOC Certification
PHS Assignment Request Form	14	PHS Assignment Request Form
Fellowship Electronic PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	16, 17, 18	Landing Page ,   Inclusion Enrollment Report ,   HSCT Sections 1-6
398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	16, 18, 17	Inclusion Enrollment Report ,   HSCT Sections 1-6 ,   Landing Page
PHS 416-5	29	PHS 416.5
PHS 398 Training Subaward Budget Attachment(s) Form	7	Attachment 5M PHS 398 Training Subaward Budget Form
SBIR/STTR Funding Agreement Certification	27, 28	SBIR Life Cycle Certification ,   STTR Life Cycle Certification
PHS 398 Research Plan	8	PHS 398 Research Plan form
PHS 398 Paper	1, 2	PHS 398 Paper Application Forms ,   PHS 398 Paper Application Instructions
PHS Assignment Request Form	3	PHS Assignment Reqest Form
PHS 398 Cover Page Supplement	4	PHS 398 Cover Page Supplement Forms
PHS 398 Modular Budget	5	PHS 398 Modular Budget Form Instruction Forms
PHS 398 Training Budget	6	PHS 398 Training Budget Form

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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	421,777	421,777	0	0	0	0
Annual Time Burden (Hours)	2,150,389	2,150,389	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:

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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? 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: 06/30/2020

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