PHS Applications and Pre-award Related Reporting (OD)

ICR 202207-0925-002

OMB: 0925-0001

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form
Unchanged
Form
Unchanged
Form
Unchanged
Form and Instruction
Unchanged
Form
Unchanged
Form
Unchanged
Form
Unchanged
Form
Unchanged
Form and Instruction
Unchanged
Form
Unchanged
Form
Unchanged
Supplementary Document
2022-07-21
Supplementary Document
2022-07-21
Supplementary Document
2022-07-21
Supplementary Document
2022-07-21
Supplementary Document
2022-07-21
Supplementary Document
2022-07-21
Justification for No Material/Nonsubstantive Change
2022-07-21
Supplementary Document
2021-08-10
Supporting Statement A
2021-08-10
Supplementary Document
2021-08-10
Supplementary Document
2021-08-10
Supplementary Document
2019-12-27
ICR Details
0925-0001 202207-0925-002
Received in OIRA 202108-0925-001
HHS/NIH 19797
PHS Applications and Pre-award Related Reporting (OD)
No material or nonsubstantive change to a currently approved collection   No
Regular 07/22/2022
  Requested Previously Approved
09/30/2024 09/30/2024
413,393 413,393
2,023,454 2,023,454
0 0

The National Institutes of Health (NIH) and other Public Health Service (PHS) agencies currently use the Research and Research Training Grant Applications and Related Forms and Ruth L. Kirschstein National Research Service Award (NRSA) Applications and Related Forms (0925-0001 Expiration Date: February 28, 2023). This collection is being revised to convert the Inclusion Enrollment Report form to a Common form to include the Department of Defense (DoD) and any other agencies who wishes to use this form in the future. The forms original use will remain the same from previous submissions however, it will take on a new OMB# and expiration date from the other forms associated with this submission. The Inclusion Enrollment Report is used for all applications 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. In addition to converting the Inclusion Enrollment Report to a common form, other revisions include NIH requiring applicants and recipients to provide their Unique Entity Identifier (UEI) instead of the Data Universal Number System (DUNS) number starting in January 2022. Also, the application forms will be updated to align with the Grants.gov updated Country and State lists.

US Code: 42 USC 288 Name of Law: Public Health Serive Act
   US Code: 42 USC 300 Name of Law: Public Health Service 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 285 Name of Law: public Health Serice Act
   US Code: 42 USC 241 Name of Law: Public Health Service
  
None

Not associated with rulemaking

  86 FR 18992 04/12/2021
86 FR 43559 08/09/2021
No

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

  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 413,393 413,393 0 0 0 0
Annual Time Burden (Hours) 2,023,454 2,023,454 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This submission represents a program change due to a conversion of the Inclusion Enrollment Report form which is being converted to a Common form to include the Department of Defense (DoD). Also, the PHS Human Subjects and Clinical Trial Information form burden (5,030) was inadvertently listed twice. Additionally, burden (3,354) was added to the PHS Assignment Request Form line item, but it was intended to be a header. The burden estimate has now been adjusted to a difference of 126,935 hours. See SSA A.15 for description of noteworthy changes

$238,382
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.
07/22/2022


© 2024 OMB.report | Privacy Policy