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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0925-0001
ICR Reference No:
202210-0925-002
Status:
Active
Previous ICR Reference No:
202207-0925-002
Agency/Subagency:
HHS/NIH
Agency Tracking No:
19797
Title:
PHS Applications and Pre-award Related Reporting (OD)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
01/13/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/05/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2026
36 Months From Approved
09/30/2024
Responses
486,749
0
413,393
Time Burden (Hours)
2,175,670
0
2,023,454
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
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
US Code:
42 USC 288
Name of Law: Public Health Serive Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
87 FR 34891
06/08/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 60180
10/04/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
21
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)
1
General Non-Fellowship Biographical Sketch Format Page
Data Management Sharing Plan
1
DMS Plan Format Page
Data Tables
10
Introduction to the Data Tables
NIH Other Transaction Application Form
1
Other Transaction Application Form Screenshots
PHS 398 Career Development Award Supplemental Form
1
PHS 398 Career Development Form Instructions
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
1
PHS 398 Research Plan Form
PHS 398 Research Training Program Plan
1
PHS 398 Research Training Program Plan
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, 1
eRA Commons Profile Data Elements
,
PHS Fellowship Supplemental Form
SBIR/STTR Funding Agreement Certification
1, 2
SBIR Funding Agreement Certification
,
STTR Funding Agreement Certification
VCOC Certification
26
VCOC Certification
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
486,749
413,393
0
73,356
0
0
Annual Time Burden (Hours)
2,175,670
2,023,454
0
152,216
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This submission represents a program change due to the implementation of the NIH Data Management and Sharing Policy and the introduction of the new optional Data Management and Sharing Plan format page. Burden hours of 146,234 were added to the new Data Management and Sharing Plan line item. The application form for the NIH Other Transactions was also added to this collection; 2,629 burden hours were added to the NIH Other Transaction Application Form line item. The PHS Fellowship Supplemental Form (includes F reference letters) estimated time went from 12.5 hours to 13 hours. The burden estimate has now been adjusted to a difference of 152,216.
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
Agency Contact:
Mikia Currie 3014350941
Common Form ICR:
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:
(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:
10/05/2022
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