PHS Applications and Pre-award Related Reporting (OD)

Forms and Documents

Document Name	Status
Form 1 PHS 398 Paper Form and Instruction	Modified
Form 1 PHS 416-5 Form and Instruction	New
Form 1 SBIR/STTR Funding Agreement Certification Form and Instruction	New
Form 1 VCOC Certification Form and Instruction	New
Form 1 PHS 6031 Form and Instruction	New
Form 3 416-1 Form and Instruction	New
Form 1 Biosketch (Fellowship) Form and Instruction	New
Form 1 PHS Inclusion Enrollment Report Form and Instruction	New
Form 1 PHS Fellowship Supplemental Form (includes F reference letters) Form and Instruction	New
Form 1 Biosketch (424 Electronic) Form and Instruction	New
Form 1 PHS 398 Career Development Award Supplemental Form Form and Instruction	New
Form 1 Data Tables Form and Instruction	New
Form 1 PHS 398 Research Training Program Plan Form and Instruction	New
Form 1 PHS 398 Research Plan Form and Instruction	New
Form 1 PHS 398 Training Subaward Budget Attachment(s) Form Form and Instruction	New
Form 1 PHS 398 Training Budget Form and Instruction	New
Form 1 PHS 398 Modular Budget Form and Instruction	Modified
Form 1 PHS Inclusion Enrollment Report Form and Instruction	Modified
Form 1 PHS 398 Cover Page Supplement Form and Instruction	Modified
Form 2 PHS Assignment Request Form Form and Instruction	Modified
Form 5A 398 Forms and Instructions (Electronic) Form and Instruction	Removed
Attachment 1 Former Revised and New Content of Information Collections 10.2015.docx Supplementary Document	2015-10-06
Supporting Statement A for 0925-0001 October 2015 ver5 FINAL 10062015.docx Supporting Statement A	2015-10-06
Attachment 1 Former and Revised Content of Information Collections.docx Supplementary Document	2015-07-28
Attachment 15 eRA Commons Profile Data Elements.xlsx Supplementary Document	2015-07-20

IC Document Collections

IC ID	Document Title	Status
37814	PHS 398 Paper Form and Instruction	Modified
217591	PHS 416-5 Form and Instruction	New
217570	SBIR/STTR Funding Agreement Certification Form and Instruction	New
217569	VCOC Certification Form and Instruction	New
217568	PHS 6031 Form and Instruction	New
217567	416-1 Form and Instruction	New
217566	Biosketch (Fellowship) Form and Instruction	New
217565	PHS Inclusion Enrollment Report Form and Instruction	New
217564	PHS Assignment Request Form Instruction	New
217563	PHS Fellowship Supplemental Form (includes F reference letters) Form and Instruction	New
217561	Biosketch (424 Electronic) Form and Instruction	New
217560	PHS 398 Career Development Award Supplemental Form Form and Instruction	New
217559	Data Tables Form and Instruction	New
217558	PHS 398 Research Training Program Plan Form and Instruction	New
217557	PHS 398 Research Plan Form and Instruction	New
217556	PHS 398 Training Subaward Budget Attachment(s) Form Form and Instruction	New
217555	PHS 398 Training Budget Form and Instruction	New
202980	PHS 398 Modular Budget Form and Instruction	Modified
202979	PHS Inclusion Enrollment Report Form and Instruction	Modified
202963	PHS 398 Cover Page Supplement Form and Instruction	Modified
202959	PHS Assignment Request Form Form and Instruction	Modified
182171	398 Forms and Instructions (Electronic) Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0001	ICR Reference No: 201507-0925-007
Status: Historical Active	Previous ICR Reference No: 201409-0925-006
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 with change	Conclusion Date: 10/09/2015
	Date Received in OIRA: 08/05/2015
Terms of Clearance: All materials distributed to respondents (online and paper) must clearly display the approved OMB control number, expiration date, and respective burden hours for the information collections.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2018	36 Months From Approved	10/31/2015
Responses	420,101	0	94,326
Time Burden (Hours)	850,756	0	2,051,794
Cost Burden (Dollars)	0	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). 0925-0001 will expire on August 31, 2015. This 0925-0001 revision submission consolidates application and other related pre-award reporting requirements previously collected under 0925-0001. Post-award reporting requirements, including the Research Performance Progress Report (RPPR), are similarly consolidated and concurrently submitted under 0925-0002 (expiration August 31, 2015).

---

Authorizing Statute(s): US Code: 42 USC 285 Name of Law: public Health Serice Act
   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 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:
	80 FR 13567	03/16/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 46591	08/05/2015
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
PHS 398 Paper	1, 2	PHS 398 Paper Application ,   PHS 398 Paper Application
PHS Assignment Request Form	1, 2	PHS Assignment Request Instruction ,   Attachment 5C PHS Assignment Request Form
PHS 398 Cover Page Supplement	1, 2	Attachment 5E PHS 398 Cover Page Supplement Form ,   Attachment 5D PHS 398 Cover Page Supplement Instructions
PHS Inclusion Enrollment Report	1, 2	Attachment 5G PHS Inclusion Enrollment Report ,   Attachment 5F PHS Inclusion Enrollment Report Instructions
PHS 398 Research Training Program Plan	1	Attachment 5S PHS 398 Research Training Program Plan Form
416-1	5, 4, 6, 1, 2, 3	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 ,   Attachment 7B PHS 416-1 Face Page 1 ,   Attachment 7C PHS 416-1 Face Page 2
VCOC Certification	1	VCOC Certification
SBIR/STTR Funding Agreement Certification	1, 2	SBIR Funding Agreement Certification ,   STTR Funding Agreement Certification
398 Forms and Instructions (Electronic)	5D, 5E, 5F, 5G, 5C, 5A, 5B	Components of an Application to NIH or Other PHS Agencies ,   Completing PHS 398 Components ,   PHS 398 Research Plan ,   Supplemental Instructions for Preparing an Individual Research Career Development Award Application ("K" Series) ,   PHS 398 Career Development Form ,   Supplemental Instructions for Preparing an Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application ,   PHS 398 Research Training Plan Form
PHS 398 Modular Budget	1, 2	Attachment 5I PHS 398 Modular Budget Form ,   Attachment 5H PHS 398 Modular Budget Instructions
PHS Inclusion Enrollment Report	1	Attachment 5G PHS Inclusion Enrollment Report
Biosketch (Fellowship)	1	Fellowship Applicant Biographical Format Page
PHS 398 Training Budget	2, 1	Attachment 5K PHS 398 Training Budget Form ,   Attachment 5J PHS 398 Training Budget Instructions
Data Tables	1, 3	Data Tables ,   Introduction to the Data Tables
Biosketch (424 Electronic)	1	General Biographical Sketch Format Page
PHS 6031	1	PHS 6031
PHS 416-5	1	Individual Fellowship Activation Notice
PHS 398 Training Subaward Budget Attachment(s) Form	1	Attachment 5M PHS 398 Training Subaward Budget Attachment(s) Form
PHS 398 Research Plan	1	Attachment 5O PHS 398 Research Plan Form
PHS 398 Career Development Award Supplemental Form	1	Career Development Supplemental Form
PHS Fellowship Supplemental Form (includes F reference letters)	1	Fellowship Supplemental Form
PHS Assignment Request Form	1	Attachment 5C PHS Assignment Request Form

---

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	420,101	94,326	0	325,775	0	0
Annual Time Burden (Hours)	850,756	2,051,794	0	-1,201,038	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: Miscellaneous Actions

Short Statement: This submission represents program changes; previous estimated total burden hours for 0925-0001 were 2,051,794; current estimated total burden hours for 0925-0001 is 850,756. This represents a decrease of 1,201,038 hours since the last approval. Although there has been an increase in application submissions, a recalculation of all pre-award burden hours that are broken up by individual form has allowed for a more accurate reflection of the burden placed on the respondents. Overall, the burden hour estimates for PHS forms did not change.

---

Annual Cost to Federal Government: $46,070

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

---

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: 08/05/2015

---