PHS Applications and Pre-award Related Reporting (OD)

Forms and Documents

Document Name	Status
Form 1 PHS 398 Paper Form	Modified
Form 16 Fellowship Electronic PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report) Form and Instruction	Removed
Form 16 398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report) Form and Instruction	Modified
Form 29 PHS 416-5 Form and Instruction	Modified
Form 27 SBIR/STTR Funding Agreement Certification Form and Instruction	Modified
Form 26 VCOC Certification Form and Instruction	Modified
Form 1 PHS 6031 Form and Instruction	Modified
Form 19 416-1 Form and Instruction	Modified
Form 15 Biosketch (Fellowship) Form and Instruction	Modified
Form 14 PHS Assignment Request Form Form	Removed
Form 13 PHS Fellowship Supplemental Form (includes F reference letters) Form	Modified
Form 12 Biosketch (424 Electronic) Form	Modified
Form 11 PHS 398 Career Development Award Supplemental Form Form	Modified
Form 10 Data Tables Form and Instruction	Modified
Form 9 PHS 398 Research Training Program Plan Form	Modified
Form 8 PHS 398 Research Plan Form	Modified
Form 7 PHS 398 Training Subaward Budget Attachment(s) Form Form	Modified
Form 6 PHS 398 Training Budget Form	Modified
Form 5 PHS 398 Modular Budget Form and Instruction	Modified
Form 4 PHS 398 Cover Page Supplement Form	Modified
Form 3 PHS Assignment Request Form Form	Modified
pub 30day 0001 2021-17031.pdf Supplementary Document	2021-08-10
Supporting Statement A for 0925-0001 8.5.21 final.docx Supporting Statement A	2021-08-10
Att D NIH Other Support and In-Kind_Instructions_6-28-2021.docx Supplementary Document	2021-08-10
Att C NIH Other Support Format Page_6-28-2021.docx Supplementary Document	2021-08-10
Attachment 19 HHS Approved PIA - Electronic Research Administration 7152019.docx Supplementary Document	2019-12-27

IC Document Collections

IC ID	Document Title	Status
37814	PHS 398 Paper Form	Modified
225109	Fellowship Electronic PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report) Form and Instruction	Removed
225108	398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report) Form and Instruction	Modified
217591	PHS 416-5 Form and Instruction	Modified
217570	SBIR/STTR Funding Agreement Certification Form and Instruction	Modified
217569	VCOC Certification Form and Instruction	Modified
217568	PHS 6031 Form and Instruction	Modified
217567	416-1 Form and Instruction	Modified
217566	Biosketch (Fellowship) Form and Instruction	Modified
217564	PHS Assignment Request Form Form	Removed
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 and Instruction	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 and Instruction	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: 202108-0925-001
Status: Received in OIRA	Previous ICR Reference No: 202012-0925-001
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: 08/11/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2023
Responses	413,393	421,777
Time Burden (Hours)	2,023,454	2,150,389
Cost Burden (Dollars)	0	0

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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.

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Authorizing Statute(s): 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
  

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:
	86 FR 18992	04/12/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 43559	08/09/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 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
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
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 Assignment Request Form	14	PHS Assignment Request 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

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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	413,393	421,777	0	-3,354	-5,030	0
Annual Time Burden (Hours)	2,023,454	2,150,389	0	-56,515	-70,420	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: 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

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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

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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: 08/11/2021

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