PHS Applications and Pre-award Related Reporting (OD)

Forms and Documents

Document Name	Status
Form 3A 398 Forms and Instructions (Paper) Form	Modified
Form Attachment 10 6031 Form and Instruction	Modified
Form Attachment 9 416-5 Form and Instruction	Modified
Form 6A PHS Fellowship Supplemental Form (electronic) Form and Instruction	Modified
Form 5A 398 Forms and Instructions (Electronic) Form and Instruction	Modified
Cumulative Inclusion Enrollment Report - Proposed.doc Supplementary Document	2013-03-14
Inclusion Enrollment Report Format Page - Current.doc Supplementary Document	2013-03-14
Planned Enrollment Report - Proposed.doc Supplementary Document	2013-03-14
Targeted Planned Enrollment Form - Current.doc Supplementary Document	2013-03-14
Revised PHS 398 Cover Page Supplement 3.12.2013.doc Supplementary Document	2013-03-14
0925-0001 Change Request - OMB Inclusion and Clincial Trial 3.14.2013.doc Justification for No Material/Nonsubstantive Change	2013-03-14

IC Document Collections

IC ID	Document Title	Status
37814	398 Forms and Instructions (Paper) Form	Modified
202980	6031 Form and Instruction	Modified
202979	416-5 Form and Instruction	Modified
202963	416-1 Instruction	Modified
202959	PHS Fellowship Supplemental Form (electronic) Form and Instruction	Modified
182171	398 Forms and Instructions (Electronic) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0001	ICR Reference No: 201303-0925-004
Status: Historical Active	Previous ICR Reference No: 201210-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 19146
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: Approved without change	Conclusion Date: 03/21/2013
	Date Received in OIRA: 03/21/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	08/31/2015	08/31/2015
Responses	94,326	0	94,326
Time Burden (Hours)	2,051,794	0	2,051,794
Cost Burden (Dollars)	0	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 (0925-0001) and Ruth L. Kirschstein National Research Service Award (NRSA) Applications and Related Forms (0925-0002). Both 0925-0001 and 0925-0002 will expire on June 30, 2012. In 2009, application and pre-award related forms were simultaneously submitted under both 0925-0001 and 0925-0002. This 0925-0001 submission consolidates application and other related pre-award reporting requirements previously collected under 0925-0001 and 0925-002. Post-award reporting requirements previously collected under 0925-0001 and 0925-0002, and the New Research Performance Progress Report (RPPR), are similarly consolidated and concurrently submitted under 0925-0002.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service
   US Code: 42 USC 285 Name of Law: public Health Serice Act
   US Code: 42 USC 216 Name of Law: Public health Service 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
  

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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
398 Forms and Instructions (Paper)	3A, 3B	Paper Application Form ,   NRSA Data Table Format
398 Forms and Instructions (Electronic)	5A, 5B, 5C, 5D, 5E, 5F, 5G	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 Fellowship Supplemental Form (electronic)	6A, 6B	Completing PHS Fellowship Specific Components ,   PHS Fellowship Supplemental Form
416-1	7B, 7C, 7D, 7E, 7F, 7G, 7H, 7C	Face Page ,   Face Page 3 ,   Project Performance Site Format ,   Face Page 4 ,   SPONSOR/CO-SPONSOR BIOGRAPHICAL SKETCH ,   Checklist Form Page ,   Continuation Page ,   Face Page 2
416-5	Attachment 9	Fellowship Activation Notice
6031	Attachment 10	Payment Agreement

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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	94,326	94,326	0	0	0	0
Annual Time Burden (Hours)	2,051,794	2,051,794	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:

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Annual Cost to Federal Government: $1,500,000

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: 03/21/2013

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