PHS Applications and Pre-award Related Reporting (OD)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 2 PHS 398 Paper Application Instructions	Form and Instruction	Unchanged	Available
Form 1 PHS 398 Paper Application Forms	Form	Unchanged	Available
Form 18 PHS Human Subjects and Clinical Trial Information - Sections 1-5	Form	Unchanged	Available
Form 17 PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report	Form	Unchanged	Available
Form 16 PHS Human Subjects and Clinical Trial Information - Landing Page	Form	Unchanged	Available
Form 18 PHS Human Subjects and Clinical Trial Information - Sections 1-5	Form	Unchanged	Available
Form 17 PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report	Form	Unchanged	Available
Form 16 PHS Human Subjects and Clinical Trial Information - Landing Page	Form and Instruction	Unchanged	Available
Form 29 PHS 416.5	Form and Instruction	Unchanged	Available
Form 28 STTR Funding Agreement Certification	Form and Instruction	Unchanged	Available
Form 27 SBIR Funding Agreement Certification	Form and Instruction	Unchanged	Repair queued
Form 26 VCOC Certification	Form and Instruction	Unchanged	Available
Form 25 PHS 6031	Form and Instruction	Unchanged	Available
Form 24 Attachment 7G PHS 416-1 Continuation Page	Form and Instruction	Unchanged	Available
Form 23 Attachment 7F PHS 416-1 Checklist Form Page	Form and Instruction	Unchanged	Available
Form 22 Attachment 7E PHS 416-1 Face Page 4	Form and Instruction	Unchanged	Available
Form 21 Attachment 7D PHS 416-1 Face Page 3	Form and Instruction	Unchanged	Available
Form 20 Attachment 7C PHS 416-1 Face Page 2	Form and Instruction	Unchanged	Available
Form 19 Attachment 7B PHS 416-1 Face Page 1	Form and Instruction	Unchanged	Available
Form 15 Fellowship Applicant Biographical Sketch Format Page	Form and Instruction	Unchanged	Available
Form 14 PHS Assignment Reqest Form	Form	Unchanged	Available
Form 13 PHS Fellowship Supplement Form	Form	Unchanged	Available
Form 12 General Biographical Sketch Format Page	Form	Unchanged	Available
Form 11 PHS 398 Career Development Award Supplemental Form	Form	Unchanged	Repair queued
Form 10 Introduction to the Data Tables	Form and Instruction	Unchanged	Available
Form 9 PHS 398 Research Training Program Plan Form	Form	Unchanged	Available
Form 8 PHS 398 Research Plan form	Form	Unchanged	Available
Form 7 Attachment 5M PHS 398 Training Subaward Budget Form	Form	Unchanged	Available
Form 6 PHS 398 Training Budget Form	Form	Unchanged	Available
Form 5 PHS 398 Modular Budget Instructions	Form and Instruction	Unchanged	Available
Form 4 PHS 398 Cover Page Supplement Form	Form	Unchanged	Available
Form 3 PHS Assignment Reqest Form	Form	Unchanged	Available
OMB Change Request Memo -0925-0001 Nov18.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2018-11-08	Available
TFK Instructions_OMB_2018-11 (002).docx	Supplementary Document	Uploaded 2018-11-08	Available
Attachment B - 5G PHS Human Subjects and Clinical Trials Information Instructions.docx	Supplementary Document	Uploaded 2017-08-24	Available
Attachment A - 5F and 5B PHS Human Subjects and Clinical Trial Information - Sections 1-5.pdf	Supplementary Document	Uploaded 2017-08-24	Repair queued
Attachment A - 5F and 5B PHS Human Subjects and Clinical Trial Information - Landing Page.pdf	Supplementary Document	Uploaded 2017-08-24	Available
OMB Change Request Memo to OMB - 0925-0001 - August 2017.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2017-08-24	Available
Personal Profile - eRA Screen Shot.docx	Supplementary Document	Uploaded 2017-05-25	Available
eRA Commons Profile Data Elements (ORCID ID).xlsx	Supplementary Document	Uploaded 2017-05-25	Repair queued
OMB Change Request Memo -0925-0001 May (ORCID).doc	Justification for No Material/Nonsubstantive Change	Uploaded 2017-05-25	Available
30 Day FRN 00012017-02472.pdf	Supplementary Document	Uploaded 2017-02-07	Available
Attachment 19 Privacy Impact Assessment.pdf	Supplementary Document	Uploaded 2017-01-26	Available
Attachment 18 Prior Approval Screen Shots.docx	Supplementary Document	Uploaded 2017-01-26	Available
Attachment 14 Supplemental Instructions for PHS 398 and PHS 416 Applications.docx	Supplementary Document	Uploaded 2017-01-26	Available
Attachment 2 CFDA.xlsx	Supplementary Document	Uploaded 2017-01-26	Available
Attachment 1 Former, Revised, and New Content of Information Collections.docx	Supplementary Document	Uploaded 2017-01-25	Available
Supporting Statement A for 0925-0001.docx	Supporting Statement A	Uploaded 2017-01-25	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
37814	PHS 398 Paper	Form and Instruction	Unchanged	PHS 398 Paper Application Instructions
37814	PHS 398 Paper	Form	Unchanged	PHS 398 Paper Application Forms
225109	Fellowship Electronic PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	Form	Unchanged	PHS Human Subjects and Clinical Trial Information - Sections 1-5
225109	Fellowship Electronic PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	Form	Unchanged	PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report
225109	Fellowship Electronic PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	Form	Unchanged	PHS Human Subjects and Clinical Trial Information - Landing Page
225108	398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	Form	Unchanged	PHS Human Subjects and Clinical Trial Information - Sections 1-5
225108	398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	Form	Unchanged	PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report
225108	398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	Form and Instruction	Unchanged	PHS Human Subjects and Clinical Trial Information - Landing Page
217591	PHS 416-5	Form and Instruction	Unchanged	PHS 416.5
217570	SBIR/STTR Funding Agreement Certification	Form and Instruction	Unchanged	STTR Funding Agreement Certification
217570	SBIR/STTR Funding Agreement Certification	Form and Instruction	Unchanged	SBIR Funding Agreement Certification
217569	VCOC Certification	Form and Instruction	Unchanged	VCOC Certification
217568	PHS 6031	Form and Instruction	Unchanged	PHS 6031
217567	416-1	Form and Instruction	Unchanged	Attachment 7G PHS 416-1 Continuation Page
217567	416-1	Form and Instruction	Unchanged	Attachment 7F PHS 416-1 Checklist Form Page
217567	416-1	Form and Instruction	Unchanged	Attachment 7E PHS 416-1 Face Page 4
217567	416-1	Form and Instruction	Unchanged	Attachment 7D PHS 416-1 Face Page 3
217567	416-1	Form and Instruction	Unchanged	Attachment 7C PHS 416-1 Face Page 2
217567	416-1	Form and Instruction	Unchanged	Attachment 7B PHS 416-1 Face Page 1
217567	416-1	Instruction	Unchanged
217566	Biosketch (Fellowship)	Form and Instruction	Unchanged	Fellowship Applicant Biographical Sketch Format Page
217564	PHS Assignment Request Form	Form	Unchanged	PHS Assignment Reqest Form
217563	PHS Fellowship Supplemental Form (includes F reference letters)	Form	Unchanged	PHS Fellowship Supplement Form
217561	Biosketch (424 Electronic)	Form	Unchanged	General Biographical Sketch Format Page
217560	PHS 398 Career Development Award Supplemental Form	Form	Unchanged	PHS 398 Career Development Award Supplemental Form
217559	Data Tables	Form and Instruction	Unchanged	Introduction to the Data Tables
217558	PHS 398 Research Training Program Plan	Form	Unchanged	PHS 398 Research Training Program Plan Form
217557	PHS 398 Research Plan	Form	Unchanged	PHS 398 Research Plan form
217556	PHS 398 Training Subaward Budget Attachment(s) Form	Form	Unchanged	Attachment 5M PHS 398 Training Subaward Budget Form
217555	PHS 398 Training Budget	Form	Unchanged	PHS 398 Training Budget Form
202980	PHS 398 Modular Budget	Form and Instruction	Unchanged	PHS 398 Modular Budget Instructions
202963	PHS 398 Cover Page Supplement	Form	Unchanged	PHS 398 Cover Page Supplement Form
202959	PHS Assignment Request Form	Form	Unchanged	PHS Assignment Reqest Form

ICR Details

OMB Control No: 0925-0001	ICR Reference No: 201811-0925-001
Status: Historical Inactive	Previous ICR Reference No: 201708-0925-002
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
OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 12/11/2018
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/08/2018
Terms of Clearance: Withdrawn while Program works on responses and updates.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2020	03/31/2020	03/31/2020
Responses	421,777	0	421,777
Time Burden (Hours)	2,150,389	0	2,150,389
Cost Burden (Dollars)	0	0	0

---

Abstract: This 0925-0001 revision submission consolidates application and other related pre-award reporting requirements previously collected under 0925-0001. Oversight systems and tools are critical for the NIH to ensure participant safety, data integrity, and accountability of the use of public funds. The NIH has been engaged in a multi-year effort to examine how clinical trials are supported and the level of oversight needed. The collection of more structured information about proposed clinical trials in the PHS applications and pre-award reporting requirements will facilitate the NIH's oversight of clinical trials as well as assist in understanding where needs in the NIH research portfolio may exist. In addition, some of the data collected here will ultimately be accessible to investigators to pre-populate certain sections of forms when registering their trials with ClinicalTrials.gov.

---

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 288 Name of Law: Public Health Serive 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:
	81 FR 76368	11/02/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 9573	02/07/2017
Did the Agency receive public comments on this ICR? No

---

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

table that charts list of burden

IC Title	Form No.	Form Name
398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	18, 17, 16	PHS Human Subjects and Clinical Trial Information - Landing Page ,   PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report ,   PHS Human Subjects and Clinical Trial Information - Sections 1-5
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 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)	17, 18, 16	PHS Human Subjects and Clinical Trial Information - Landing Page ,   PHS Human Subjects and Clinical Trial Information - Inclusion Enrollment Report ,   PHS Human Subjects and Clinical Trial Information - Sections 1-5
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 Form
PHS 398 Modular Budget	5	PHS 398 Modular Budget Instructions
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	25	PHS 6031
PHS Assignment Request Form	14	PHS Assignment Reqest Form
PHS Assignment Request Form	3	PHS Assignment Reqest Form
PHS Fellowship Supplemental Form (includes F reference letters)	13	PHS Fellowship Supplement Form
SBIR/STTR Funding Agreement Certification	27, 28	SBIR Funding Agreement Certification ,   STTR Funding Agreement Certification
VCOC Certification	26	VCOC Certification

---

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 program changes; previous estimated total burden hours for 0925-0001 were 850,756; current estimated total burden hours for 0925-0001 is 2,150,389. This represents an increase of 1,299,632 hours since the last approval. This increase is largely due to the addition of a new PHS Human Subjects and Clinical Trial Information form, as well as a recalculation of burden hour estimates on the following forms: PHS 398 Research Plan, PHS 398 Research Training Program Plan, and PHS 398 Career Development Award Supplemental Form.

---

Annual Cost to Federal Government: $222,054

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? Uncollected

---

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: 11/08/2018

---