View Information Collection Request (ICR) Package
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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:
202408-0925-001
Status:
Active
Previous ICR Reference No:
202210-0925-002
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:
12/04/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/25/2024
Terms of Clearance:
Concluded consistent with the understanding that in the next revision/extension of the package (no later than March 28, 2029), the agency will update the race/ethnicity question in this information collection to be in compliance with the updated SPD 15 (effective as of March 28, 2024).
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2027
36 Months From Approved
01/31/2026
Responses
486,749
0
486,749
Time Burden (Hours)
2,175,670
0
2,175,670
Cost Burden (Dollars)
0
0
0
Abstract:
Effective for due dates on or after January 25, 2025, NIH will be implementing several trans-NIH initiatives to simplify the grants process for applicants and recipients as well as for peer review. NIH will be updating fellowship applications to improve fellowship peer review to facilitate the mission of these programs to identify the most promising candidates and individualized training opportunities that will assist them along their paths to support the advancement of the biomedical research enterprise. NIH will reduce the number of required attachments and updating instructions for the PHS Fellowship Supplemental Form to align with the revised review criteria. NIH will be updating institutional training grant applications, adding a new attachment field to the PHS 398 Research Training Program Plan form for the transparent collection of the Recruitment Plan to Enhance Diversity while also providing additional space for applicants within the Program Plan page limit where this information was previously collected. The Training Data Tables will be updated to reduce burden and promote consistent information collection, including limiting the scope of information collection to data only relevant to the training stage(s) of the proposed program in Table 1 and removing instructions in Table 8 that are reported within the RPPR. Effective for due dates on or after May 25, 2025, NIH will adopt the Common Forms for Biographical Sketch and Current and Pending (Other) Support as part of the directive from Guidance for Implementing National Security Presidential Memorandum (NSPM)-33. The Common Forms are part of a separate OMB collection, approved under 3145-0279. Elements that will be collected within the Common Forms will be removed from NIH’s current NIH Biosketch and Other Support formats. NIH will continue to collect information not captured on the Common Forms to adhere to the agency’s implementation of the NIH Peer Review Regulations at 42 CFR Part 52 as part of the NIH Biosketch form, to be renamed the NIH Biographical Sketch Supplement, to reflect the supplemental information requested. The application and progress report forms and associated instructions will be updated to align with these new requirements.
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:
89 FR 45001
05/22/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 77872
09/24/2024
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
1, 2, 3
Form
,
Form
,
Form
416-1
1, 2, 3, 4, 5, 6, 7
Form
,
Form
,
Form
,
Form
,
Form
,
Form
,
Form
Biosketch (424 Electronic)
2, 1
Form
,
Form
Biosketch (Fellowship)
1, 2, 3, 4
Form
,
Form
,
Form
,
Form
Data Management Sharing Plan
1, 2, 3
Form
,
Form
,
Form
Data Tables
1, 2, 3, 4
Form
,
Form
,
Form
,
Form
NIH Other Transaction Application Form
1, 2
Form
,
Form
PHS 398 Career Development Award Supplemental Form
1, 2
Form
,
Form
PHS 398 Cover Page Supplement
1, 2
Application
,
Application
PHS 398 Modular Budget
1, 2, 3, 4
Form
,
Form
,
Form
,
Form
PHS 398 Paper
1, 2
Application
,
Application
PHS 398 Research Plan
1, 2
Form
,
Form
PHS 398 Research Training Program Plan
1, 2
Form
,
Form
PHS 398 Training Budget
1, 2
Form
,
Form
PHS 398 Training Subaward Budget Attachment(s) Form
1, 2
Form
,
Form
PHS 416-5
1
Form
PHS 6031
1
Form
PHS Assignment Request Form
1, 2
Application
,
Application
PHS Fellowship Supplemental Form (includes F reference letters)
1, 2
Form
,
Form
SBIR/STTR Funding Agreement Certification
1, 2
Form
,
Form
VCOC Certification
1
Form
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
486,749
0
0
0
0
Annual Time Burden (Hours)
2,175,670
2,175,670
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:
Annual Cost to Federal Government:
$171,495
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:
09/25/2024
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