Download NIH SF424 R&R Application Guide Adobe Forms Version C PDF

TitleNIH SF424 R&R Application Guide Adobe Forms Version C
LanguageEnglish
File Size3.8 MB
Total Pages176
Table of Contents
                            1. Foreword
	1.1 Application Guide Format
	1.2 NIH Extramural Research and Research Training Programs
	1.3 Program Guidelines
		1.3.1 Three-Phase Program
		1.3.2 Fast-Track Applications
		1.3.3 Supplemental Applications
		1.3.4 SBIR/STTR Program Eligibility
			1.3.4.1 Organizational Criteria
				SBIR Program
				STTR Program
				SBIR and STTR
	1.4 Interactions with PHS Staff
	1.5 Grants Policy Statements
	1.6 References
		1.6.1 Other Resources
	1.7 Authorization
		1.7.1 Collection of Personal Demographic Data
	1.8 Paperwork Burden
2. Process for Application Submission via Grants.gov
	2.1 Overview
	2.2 Registration Process
		2.2.1 Grants.gov Registration
		2.2.2 eRA Commons Registration
			2.2.2.1 Commons Registration for the Organization
			2.2.2.2 Commons Registration for the Program Directors/Principal Investigators (PD/PIs)
			2.2.2.3  Commons Registration for Other Individuals Participating in NIH Progress Reports
		2.2.3 SBA Company Registration
	2.3 Software Requirements
		2.3.1 Adobe Reader
		2.3.2 Creating PDFs for Text Attachments
	2.4 Funding Opportunities
		2.4.1 NIH Guide for Grants and Contracts
		2.4.2 Funding Opportunity Announcements
		2.4.3 Finding a Funding Opportunity Announcement (FOA) for Grants.gov Submission
	2.5 Forms for an Application to NIH or Other PHS Agencies
	2.6 Format Specifications for Text (PDF) Attachments
	2.7 Resubmission Applications
	2.8 Revision Application
	2.9 Similar, Essentially Identical, or Identical Applications
	2.10 Submitting your Application via Grants.gov
	2.11 After you Submit your Application via Grants.gov
	2.12 Correcting Errors
	2.13 Post-Submission Application Materials
	2.14 Application Due Dates
	2.15 Submission, Review and Award Cycles
	2.16 Resources for Finding Help
		2.16.1 Finding Help for Grants.gov Registration or Submissions
		2.16.2 Finding Help for the eRA Commons Registration or eRA Commons Validation Processes
		2.16.3 Finding Help for Application Preparation
		2.16.4 Finding Help for SBIR/STTR Specific Inquiries
		2.16.5 Finding Help for SBA Company Registry
3. Using the Grant Application Package
	3.1 Verify Grant Information
	3.2 Enter the Name for the Application
	3.3 Open and Complete Mandatory Documents
	3.4 Open and Complete Optional Documents
	3.5 Submitting the Application via Grants.gov
4. Completing the SF 424 Research and Related (R&R) Forms
	4.1 Overview
	4.2 SF 424 (R&R) Form
	4.3 Project/Performance Site Locations Form
	4.4 Other Project Information Form
	4.5 Senior/Key Person Profile (Expanded) Form
	4.6 (Reserved)
	4.7 R&R Budget Form
		4.7.1 Sections A and B
		4.7.2 Sections C through E
		4.7.3 Sections F through K
		4.7.4 Cumulative Budget
	4.8 Special Instructions for Preparing Applications with a Subaward/Consortium
	4.9 SBIR/STTR Information Form
5. Completing PHS 398 Forms
	5.1 Overview
	5.2 (Reserved)
	5.3 Cover Page Supplement Form
	5.4 (Reserved)
	5.5 PHS 398 Research Plan Form
	5.6 (Reserved)
	5.7 (Reserved)
	5.8 Planned Enrollment Report and Cumulative Inclusion Enrollment Report
		5.8.1 Planned Enrollment Report
		5.8.2 Cumulative Inclusion Enrollment Report
6. Peer Review Process
                        
Document Text Contents
Page 1

U.S. Department of Health and Human Services
Public Health Service

SF424 (R&R)
SBIR/STTR

Application Guide for NIH
and Other PHS Agencies

A guide developed and maintained by NIH for preparing and
submitting SBIR/STTR applications via Grants.gov to NIH and other

PHS agencies using the SF424 (R&R)*

Forms Version C application packages

Updated November 25, 2015

*Use for due dates 25, 2016 For due
use the

http://grants.nih.gov/grants/how-to-apply-application-guide.htm

Page 2

Table of Contents
1. Foreword 1

1.1 Application Guide Format 2

1.2 NIH Extramural Research and Research Training Programs 3

1.3 Program Guidelines 3

1.3.1 Three-Phase Program 3

1.3.2 Fast-Track Applications 5

1.3.3 Supplemental Applications 6

1.3.4 SBIR/STTR Program Eligibility 6

1.3.4.1 Organizational Criteria 7

SBIR Program 7

STTR Program 8

SBIR and STTR 9

1.4 Interactions with PHS Staff 10

1.5 Grants Policy Statements 12

1.6 References 12

1.6.1 Other Resources 14

1.7 Authorization 15

1.7.1 Collection of Personal Demographic Data 16

1.8 Paperwork Burden 16

2. Process for Application Submission via Grants.gov 17

2.1 Overview 17

2.2 Registration Process 18

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SBIR/STTR SF 424 (R&R) Forms Version C Application Guide

Part I: Instructions for Preparing and Submitting an Application

Check “Yes” even if the IACUC review and approval process has not yet begun.

IACUC Approval Date

Enter the latest IACUC approval date (if available). Leave blank if Pending.

IACUC approval must have been granted within three years to be valid. Note that an 
IACUC Approval Date is not required at the time of submission. NIH does not require 
verification of review and approval of the proposed research by the IACUC before peer 
review of the application. However, this information is required under Just-In-Time Policy.

Animal Welfare Assurance Number

Enter the Federally approved assurance number, if available.

Enter “None” if the applicant organization does not have an OLAW-approved Animal 
Welfare Assurance. To determine if the applicant organization holds an Animal Welfare 
Assurance, see the lists of Domestic and Foreign Assured institutions. Do not enter the
Animal Welfare Assurance number for a Project/Performance Site of a collaborating
institution. When an applicant organization does not have an Animal Welfare Assurance, 
the Authorized Organization Representative’s signature on the application constitutes 
declaration that the applicant organization will submit an Animal Welfare Assurance when 
requested by OLAW. If the applicant organization has neither an animal care and use 
program, facilities to house animals and conduct research on site, nor an IACUC, and the 
animal work will be conducted at an institution with an Animal Welfare Assurance, the 
applicant must obtain an Inter-institutional Assurance from OLAW prior to an award.

3. Is proprietary/privileged information included in the application?

Patentable ideas, trade secrets, privileged or confidential commercial or financial information, 
disclosure of which may harm the applicant, should be included in applications only when such 
information is necessary to convey an understanding of the proposed project. If the application 
includes such information, check yes and clearly mark each line or paragraph on the pages 
containing the proprietary/privileged information with a legend similar to: “The following contains 
proprietary/privileged information that (name of applicant) requests not be released to persons 
outside the Government, except for purposes of review and evaluation.” This field is required.

If a grant is awarded as a result of or in connection with the submission of this application, 
the Government shall have the right to use or disclose the information to the extent 
authorized by law. Although the grantee institution and the PD/PI will be consulted about 
any such disclosure, the PHS will make the final determination. Any indication by the 
applicant that the application contains proprietary or privileged information does not 
automatically shield the information from release in response to a Freedom of Information 
Act (FOIA) request should the application result in an award (see 45 CFR Part 5).  If an 
applicant fails to identify proprietary information at the time of submission as instructed in 

I-82

http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf#1_7_just_in_time_policy
http://grants.nih.gov/grants/olaw/assurance/300index.htm
http://grants.nih.gov/grants/olaw/assurance/500index.htm

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Part I: Instructions for Preparing and Submitting an Application

the application guide, a significant substantive justification will be required to withhold the 
information if requested under FOIA.

4. Environmental Questions

Most NIH research grants are not expected to individually or cumulatively have a 
significant effect on the environment, and NIH has established several categorical 
exclusions allowing most applicants to answer ‘No’ to this question unless a specific FOA 
indicates that the National Environmental Policy Act (NEPA) applies. However, if an 
applicant expects that the proposed project will have an actual or potential impact on the 
environment, or if any part of the proposed research and/or project includes one or more of 
the following categorical exclusions listed below, the box marked “Yes” should be checked 
and an explanation provided in field 4.b.

 1.  The potential environmental impacts of the proposed research may be of greater scope or 
size than other actions included within a category.

 2.  The proposed research threatens to violate a Federal, State, or local law established for the 
protection of the environment or for public health and safety.

 3.  Potential effects of the proposed research are unique or highly uncertain.
 4.  Use of especially hazardous substances or processes is proposed for which adequate and 

accepted controls and safeguards are unknown or not available.
 5.  The proposed research may overload existing waste treatment plants due to new loads 

(volume, chemicals, toxicity, additional hazardous wasted, etc.)
 6.  The proposed research may have a possible impact on endangered or threatened species.
 7.  The proposed research may introduce new sources of hazardous/toxic wastes or require 

storage of wastes pending new technology for safe disposal.
 8.  The proposed research may introduce new sources of radiation or radioactive materials.
 9.  Substantial and reasonable controversy exists about the environmental effects of the 

proposed research.

4.a. Does this project have an actual or potential impact on the environment?

Indicate if this project has an actual or potential impact on the environment? Click No here if this 
is not the case. This field is required.

4.b. If yes, please explain

Explanation of the actual or potential impact on the environment.

4.c. If this project has an actual or potential impact on the environment, has an exemption
been authorized or an Environmental Assessment (EA) or an Environmental Impact
Statement (EIS) been performed?

Check yes or no. This field is required.

4.d. If yes, please explain

I-83

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SBIR/STTR SF 424 (R&R) Forms Version C Application Guide

Part I: Instructions for Preparing and Submitting an Application

Inclusion of Women, Minorities, and Children. When the proposed project involves human 
subjects and/or NIH-defined clinical research, the committee will evaluate the proposed 
plans for inclusion (or exclusion) of individuals on the basis of sex/gender, race, and 
ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in 
terms of the scientific goals and research strategy proposed. For additional information on 
review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate 
animals as part of the scientific assessment according to the following criteria: (1) 
description of  procedures involving animals including species, strains, ages, sex, and total 
number to be used; (2) justifications for the use of animals versus alternative models and for 
the appropriateness of the species proposed; (3) interventions to minimize discomfort, 
distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with 
the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of 
chimpanzees as they would any other application proposing the use of vertebrate animals. 
For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are 
potentially hazardous to research personnel and/or the environment, and if needed, 
determine whether adequate protection is proposed.

Resubmission Applications.  When reviewing a Resubmission application (formerly called 
an amended application), the committee will evaluate the application as now presented, 
taking into consideration the responses to comments from the previous scientific review 
group and changes made to the project.

Renewal Applications.  When reviewing a Renewal application (formerly called a 
competing continuation application), the committee will consider the progress made in the 
last funding period.

Revision Applications.  When reviewing a Revision application (formerly called a competing 
supplement application), the committee will consider the appropriateness of the proposed 
expansion of the scope of the project. If the Revision application relates to a specific line of 
investigation presented in the original application that was not recommended for approval by 
the committee, then the committee will consider whether the responses to comments from 
the previous scientific review group are adequate and whether substantial changes are 
clearly evident.

 As applicable for the project proposed, reviewers will 
address each of the following items, but will not give scores for these items and should not 
consider them in providing an overall impact/priority score.

Select Agents Research. Reviewers will assess the information provided in this section of 
the application, including 1) the select agent(s) to be used in the proposed research, 2) the 
registration status of all entities where select agent(s) will be used, 3) the procedures that 
will be used to monitor possession use and transfer of select agent(s), and 4) plans for 
appropriate biosafety, biocontainment, and security of the select agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource 
Sharing Plans, or the rationale for not sharing the following types of resources, are 
reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_
sharing_guidance.htm); 2) Sharing Model Organisms 

I-169

http://grants.nih.gov/grants/peer/guidelines_general/Review_Human_Subjects_Inclusion.pdf
http://grants.nih.gov/grants/olaw/VASchecklist.pdf
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm

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(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genomic Data 
Sharing (GDS) Plan  ( http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html.) 
For AHRQ applicants, reviewers will evaluate data management plans for merit while 
considering the values of long-term preservation, access, and the associated cost, and 
administrative burden.

Authentication of Key Biological and/or Chemical Resources: For projects involving key 
biological and/or chemical resources, reviewers will comment on the brief plans proposed 
for identifying and ensuring the validity of those resources.

Budget and Period of Support. Reviewers will consider whether the budget and the 
requested period of support are fully justified and reasonable in relation to the proposed 
research.

The second level of review will usually be performed by the Advisory Council or Board of the 
potential awarding component (Institute, Center, or other unit). Council or Board recommendations 
are based not only on considerations of scientific merit, as judged by the SRGs, but also on the 
relevance of the proposed study to an Institute/Center’s mission, programs and priorities.

I-170

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html

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