PHS Applications and Pre-award Related Reporting (OD)

ICR 202006-0925-002

OMB: 0925-0001

Federal Form Document

Forms and Documents
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Form and Instruction
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Form and Instruction
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Form and Instruction
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Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Modified
Form and Instruction
Unchanged
Form and Instruction
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Supplementary Document
2020-06-30
Supplementary Document
2020-06-30
Justification for No Material/Nonsubstantive Change
2020-06-30
Supplementary Document
2020-04-27
Justification for No Material/Nonsubstantive Change
2020-04-27
Justification for No Material/Nonsubstantive Change
2020-03-23
Supplementary Document
2020-03-23
Supplementary Document
2020-03-23
Supplementary Document
2020-03-23
Supplementary Document
2019-12-30
Supporting Statement A
2020-02-05
Supplementary Document
2019-12-27
Supplementary Document
2019-12-27
Supplementary Document
2019-12-27
Supplementary Document
2017-05-25
Supplementary Document
2017-05-25
Supplementary Document
2017-01-26
Supplementary Document
2017-01-26
Supplementary Document
2017-01-25
ICR Details
0925-0001 202006-0925-002
Historical Active 202004-0925-002
HHS/NIH 19797
PHS Applications and Pre-award Related Reporting (OD)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 07/30/2020
Retrieve Notice of Action (NOA) 06/30/2020
  Inventory as of this Action Requested Previously Approved
02/28/2023 02/28/2023 02/28/2023
421,777 0 421,777
2,150,389 0 2,150,389
0 0 0

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.

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
  
None

Not associated with rulemaking

  84 FR 14956 04/12/2019
84 FR 71967 12/30/2019
Yes

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

  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
No
No

$222,054
No
    Yes
    Yes
No
No
No
No
Mikia Currie 3014350941

  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.
06/30/2020


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