PHS Applications and Pre-award Related Reporting (OD)

OMB Control No: 0925-0001	ICR Reference No: 202207-0925-002
Status: Received in OIRA	Previous ICR Reference No: 202108-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 19797
Title: PHS Applications and Pre-award Related Reporting (OD)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/22/2022

	Requested	Previously Approved
Expiration Date	09/30/2024	09/30/2024
Responses	413,393	413,393
Time Burden (Hours)	2,023,454	2,023,454
Cost Burden (Dollars)	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 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

---

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:
	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

---

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 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

---

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	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

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: 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

---

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: 07/22/2022

---