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	New
Form 16 398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report) Form and Instruction	New
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 25 PHS 6031 Form and Instruction	Modified
Form 19 416-1 Form and Instruction	Modified
Form 15 Biosketch (Fellowship) Form and Instruction	Modified
Form 1 PHS Inclusion Enrollment Report Form and Instruction	Removed
Form 14 PHS Assignment Request Form Form	Modified
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 1 PHS Inclusion Enrollment Report Form and Instruction	Removed
Form 4 PHS 398 Cover Page Supplement Form	Modified
Form 3 PHS Assignment Request Form Form	Modified
30 Day FRN 00012017-02472.pdf Supplementary Document	2017-02-07
Attachment 19 Privacy Impact Assessment.pdf Supplementary Document	2017-01-26
Attachment 18 Prior Approval Screen Shots.docx Supplementary Document	2017-01-26
Attachment 15 eRA Commons Profile Data Elements.xlsx Supplementary Document	2017-01-26
Attachment 14 Supplemental Instructions for PHS 398 and PHS 416 Applications.docx Supplementary Document	2017-01-26
Attachment 2 CFDA.xlsx Supplementary Document	2017-01-26
Attachment 1 Former, Revised, and New Content of Information Collections.docx Supplementary Document	2017-01-25
Supporting Statement A for 0925-0001.docx Supporting Statement A	2017-01-25

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	New
225108	398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report) Form and Instruction	New
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
217565	PHS Inclusion Enrollment Report Form and Instruction	Removed
217564	PHS Assignment Request Form 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 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
202979	PHS Inclusion Enrollment Report Form and Instruction	Removed
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: 201701-0925-003
Status: Historical Active	Previous ICR Reference No: 201611-0925-001
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/15/2017
	Date Received in OIRA: 02/08/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2020	36 Months From Approved	10/31/2018
Responses	421,777	0	420,101
Time Burden (Hours)	2,150,389	0	850,756
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): US Code: 42 USC 286 Name of Law: Public Health Service Act
   US Code: 42 USC 300 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

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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:
	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

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

IC Title	Form No.	Form Name
PHS 416-5	29	PHS 416.5
PHS 398 Training Subaward Budget Attachment(s) Form	7	Attachment 5M PHS 398 Training Subaward Budget Form
PHS 398 Research Plan	8	PHS 398 Research Plan form
PHS 398 Paper	2, 1	PHS 398 Paper Application Forms ,   PHS 398 Paper Application Instructions
PHS Assignment Request Form	3	PHS Assignment Reqest 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 Training Budget	6	PHS 398 Training Budget Form
PHS Inclusion Enrollment Report	1	Attachment 5G PHS Inclusion Enrollment Report
Fellowship Electronic PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	16, 17, 18	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 Inclusion Enrollment Report	1, 2	Attachment 5G PHS Inclusion Enrollment Report ,   Attachment 5F PHS Inclusion Enrollment Report Instructions
398/424 PHS Human Subjects and Clinical Trial Information (includes inclusion enrollment report)	16, 17, 18	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
Data Tables	10	Introduction to the Data Tables
Biosketch (424 Electronic)	12	General Biographical Sketch Format Page
PHS 6031	25	PHS 6031
PHS 398 Career Development Award Supplemental Form	11	PHS 398 Career Development Award Supplemental Form
PHS Fellowship Supplemental Form (includes F reference letters)	13	PHS Fellowship Supplement Form
PHS Assignment Request Form	14	PHS Assignment Reqest Form
Biosketch (Fellowship)	15	Fellowship Applicant Biographical Sketch Format Page
PHS 398 Research Training Program Plan	9	PHS 398 Research Training Program Plan Form
416-1	21, 22, 24, 23, 19, 20	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
VCOC Certification	26	VCOC Certification
SBIR/STTR Funding Agreement Certification	27, 28	SBIR Funding Agreement Certification ,   STTR Funding Agreement Certification

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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	421,777	420,101	0	1,676	0	0
Annual Time Burden (Hours)	2,150,389	850,756	0	1,299,633	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Forms

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.

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Annual Cost to Federal Government: $222,054

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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

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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: 02/08/2017

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