PHS Applications and Pre-award Related Reporting (OD)

Forms and Documents

Document Name	Status
Form 1 PHS 398 Paper Form	Modified
Form 1 NIH Other Transaction Application Form Form	Modified
Form 1 Data Management Sharing Plan Form	Modified
Form 1 398/424 PHS Human Subjects and Clinical Trial Information Form	Modified
Form 1 PHS 416-5 Form	Modified
Form 1 SBIR/STTR Funding Agreement Certification Form	Modified
Form 1 VCOC Certification Form	Modified
Form 1 PHS 6031 Form	Modified
Form 1 Biosketch (Fellowship) Form	Modified
Form 1 PHS Fellowship Supplemental Form (includes F reference letters) Form	Modified
Form 1 Biosketch (424 Electronic) Form	Modified
Form 1 PHS 398 Career Development Award Supplemental Form Form	Modified
Form 1 Data Tables Form	Modified
Form 1 PHS 398 Research Training Program Plan Form	Modified
Form 1 PHS 398 Research Plan Form	Modified
Form 1 PHS 398 Training Subaward Budget Attachment(s) Form Form	Modified
Form 1 PHS 398 Training Budget Form	Modified
Form 1 PHS 398 Modular Budget Form	Modified
Form 1 PHS 398 Cover Page Supplement Form	Modified
Form 1 PHS Assignment Request Form Form	Modified
30day 0001.pdf Supplementary Document	2024-09-24
Support Statement A_0925-0001-FORMS-I_final.docx Supporting Statement A	2024-08-28
Attachment Att D_nih-other-support-instructions-rev-06-28-2021.docx Supplementary Document	2024-08-28
Attachment Att C_other-support-format-page-rev-10-2021.docx Supplementary Document	2024-08-28
Attachment 19_eRA PIA 1-12-24.pdf Supplementary Document	2024-08-28

IC Document Collections

IC ID	Document Title	Status
37814	PHS 398 Paper Form	Modified
256274	NIH Other Transaction Application Form Form	Modified
256273	Data Management Sharing Plan Form	Modified
225108	398/424 PHS Human Subjects and Clinical Trial Information Form	Modified
217591	PHS 416-5 Form	Modified
217570	SBIR/STTR Funding Agreement Certification Form	Modified
217569	VCOC Certification Form	Modified
217568	PHS 6031 Form	Modified
217567	416-1 Instruction	Modified
217566	Biosketch (Fellowship) Form	Modified
217563	PHS Fellowship Supplemental Form (includes F reference letters) Form	Modified
217561	Biosketch (424 Electronic) Form	Modified
217560	PHS 398 Career Development Award Supplemental Form Form	Modified
217559	Data Tables Form	Modified
217558	PHS 398 Research Training Program Plan Form	Modified
217557	PHS 398 Research Plan Form	Modified
217556	PHS 398 Training Subaward Budget Attachment(s) Form Form	Modified
217555	PHS 398 Training Budget Form	Modified
202980	PHS 398 Modular Budget Form	Modified
202963	PHS 398 Cover Page Supplement Form	Modified
202959	PHS Assignment Request Form Form	Modified

ICR Details

OMB Control No: 0925-0001	ICR Reference No: 202408-0925-001
Status: Received in OIRA	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	Date Submitted to OIRA: 09/25/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2026
Responses	486,749	486,749
Time Burden (Hours)	2,175,670	2,175,670
Cost Burden (Dollars)	0	0

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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.

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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

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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:
	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

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

IC Title	Form No.	Form Name
398/424 PHS Human Subjects and Clinical Trial Information	3, 1, 2	Form ,   Form ,   Form
416-1	1, 2, 3, 7, 4, 5, 6	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

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ICR Summary of Burden

	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	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:

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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

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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: 09/25/2024

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