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1. Is Your Small Business Registered with Grants.gov?

• For those applicant organizations still needing to register with Grants.gov, registration information can be found on the Grants.gov Get Started website (http://www.grants.gov/GetStarted).
• Principal Investigators (PIs) do not have to register in Grants.gov unless they also serve as the Authorized Organizational Representative for their institution.

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2. Is Your Small Business and is the Project Director/Principal Investigator (PI) Registered with eRA Commons?

Both the small business concern and the Project Director/Principal Investigator (PD/PI) must also complete a one-time registration in the eRA Commons in order to submit applications to NIH. Organizational officials are responsible for registering the PD/PI in the eRA Commons. To find out if your organization is already Commons-registered, a "List of Commons Registered Organizations" can be found at: http://era.nih.gov/userreports/ipf_com_org_list.cfm.

The PD/PI registration must be done by an organization official or their delegate who is already registered in the Commons. The PD/PI should work with their Authorized Organizational Representative (also known as Signing Official in the eRA Commons) to determine their institutional process for registration. For a step-by-step account, click on Grantee Registration Steps for Commons (PDF - 51 KB). (Note: This applies to applicants as well as grantees despite the reference to “Grantee”.)

I ran data for FY2005 and FY2006 SBIR/STTR applicants, and I learned that a large percentage of principal investigators are not yet registered in the eRA Commons. (STTR applicants: see special note below)

The eRA Commons is so important because this is now THE discrete information exchange system where NIH and the applicant/grantee community are able conduct their extramural research administration business electronically. As announced in a recent NIH Guide Notice, the following changes are currently in place:

• Summary Statements: Beginning October 1, 2005, NIH will no longer send hard copies of the Summary Statements to Principal Investigators (PIs) and Individual Fellows Applicants. Summary Statements are accessible electronically to PIs and Fellows in the eRA Commons within approximately 8 weeks of the Scientific Review Group (SRG) meeting.
• Review Outcome “Mailers”: Beginning February 1, 2006, the NIH will no longer send hard copies of the notification letter (also known as a “mailer”) to PIs and Fellows regarding the review outcome of an application by the SRG. When the SRG rosters and meeting dates become available, they may be accessed through http://www.csr.nih.gov/Committees/rosterindex.asp (Center for Scientific Review [CSR] reviews) or http://era.nih.gov/roster/ (Institute/Center reviews). Scores will be posted in the eRA Commons approximately 5 working days after the SRG meeting.

In order to avoid delays in the e-notification process, it is vital that all Applicant/Grantee Organizations, Principal lnvestigators are registered in the eRA Commons and e-mail addresses are checked periodically for accuracy.

Special Note for STTR applicants: The STTR applicant organization must officially affiliate the PD/PI with the small business concern in the Commons if the PD/PI is not an employee of the small business concern.

1. 1. PD/PI gives Commons user ID and email address to the administrator of the applicant institution. (The email address must be the one that is contained in the Personal Profile for the PI.)
2. Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.)
3. Administrator selects "Administration" tab and then "Accounts" tab.
4. Administrator selects "Create Affiliation" tab.
5. Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit."

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3. If I submit my SBIR or STTR application in November for the December 1 (or January 2, for AIDS/AIDS-related) submission date, can I send a paper application?

No. Period. Here forward, no paper applications (PHS 398 OR SF424 (R&R) are allowable. You MUST submit the SBIR/STTR application electronically to Grants.gov using the SF424 (R&R) Application Package (attached to the specific FOA) and following the SF424 (R&R) Application Guide (MS Word).

Note: Applications may be submitted beginning with the “Opening” Date of November 7, 2005.

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4. May I still use the Omnibus Solicitation of the NIH, CDC, and FDA for SBIR/STTR Grant Applications or must I find an Institute or Center (IC)- specific FOA (i.e., Program Announcement [PA] or Request for Application [RFA])?

In Grants.gov/Find, a Parent SBIR FOA (PA-06-120) and a separate Parent STTR FOA (PA-06-121) have been issued to encompass the general scientific research areas that are described in the NIH, CDC, and FDA SBIR/STTR Program Descriptions and Research Topics (MS Word) section of the Omnibus Solicitation. To apply for these opportunities, you must use the parent FOA number (i.e., PA-06-120 or PA-06-121). In short, think of the “Parent” announcements as the “omnibus” solicitation now.

Note: These two parent announcements will expire after the AIDS submission date, at which time we will post two new FOAs for the standard submission dates of April 1, August 1 and December 1, 2006.

While the Parent SBIR and STTR FOAs encompass all 24 ICs’ research topics and those of the CDC and FDA, there are other specific SBIR and STTR FOAs in Grants.gov that you may still apply for. Some NIH awarding components (e.g., National Cancer Institute, National Institute of Allergy and Infectious Diseases, National Institute of Diabetes and Digestive and Kidney Diseases) have identified additional specific SBIR and STTR funding opportunities, and these are also available in http://grants.gov/ (or http://grants.gov/Apply if the FOA number is known). For a full list that includes FOA numbers, see the NIH Special Announcements for Small Business Research Opportunities Web site.

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5. How Do I Find and Apply for an SBIR/STTR Funding Opportunity?

To “find” a funding opportunity in Grants.gov, access "Search Grant Opportunities" at the Grants.gov/Find Web site to conduct a basic search, browse by category, browse by agency (e.g., Department of Health and Human Services under which NIH, CDC, and FDA are located), or conduct an advanced search. If you know the “Funding Opportunity Number” (e.g., PA-06-120), you may go directly to Grants.gov/ to download the SF424 9R&R) Application Package and Application Guide that begin the 4-step process to apply through Grants.gov.

Once you identify a grant opportunity at Grants.gov, follow the steps described at http://era.nih.gov/ElectronicReceipt/applying.cfm to submit an application. You must download the SF424 (R&R) Application Package and Application Guide (MS Word) for a specific FOA (e.g., PA-06-120, PA-06-121) through the Grants.gov Web site. Only the forms package directly attached to a specific FOA may be used.

Remember: Before you can apply electronically, the applicant small business organization must be registered in Grants.gov and the eRA Commons.

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6. Why can’t I find the HHS Parent SBIR or Parent STTR FOA by entering a CFDA number for a specific IC (e.g., 93.853)?

Currently, when an FOA is placed into Grants.gov, Find/Apply, the system only links to one CFDA number (93.061), which is just the first of numerous CFDA numbers associated with the Parent SBIR and Parent STTR FOAs. The good news is that Grants.gov is in the process of modifying their system. The best way to identify the HHS Parent SBIR or STTR FOAs is to go to Grants.gov/ and enter the Opportunity Number by typing “PA-06-120”. This will load the SBIR funding opportunity. (If you are submitting an STTR, enter the Opportunity Number as PA-06-121).

Therefore, you do not need to enter a CFDA number. In fact, for NIH funding opportunities, it is better to enter the Opportunity Number since many of our FOAs are sponsored by multiple ICs.

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7. Why Are There Separate FOAs for the SBIR and STTR Grant Mechanisms?

Each FOA is linked to a specific Application Package. Since STTR applications have slightly different forms requirements than SBIR applications, distinct application packages had to be developed for each of these mechanisms. The good news is that you will know exactly which forms to include if you are applying for an SBIR award and which to include if you are applying for an STTR award since they will be pre-packaged.

Note: In most cases, you will find parallel FOAs of identical scientific scope (e.g., one that utilizes the SBIR (R43/R44) grant mechanisms and a parallel one that utilizes the STTR (R41/R42) grant mechanisms. We have clearly distinguished the mechanisms in the FOA title, and we also include a cross-link to the parallel FOA. Applicants may not simultaneously submit identical/essentially identical applications under two HHS funding opportunities, including the SBIR or STTR Parent FOAs (PA-06-120 or PA-06-121).

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8. Is There A Dictionary to Help Me Understand This New SF424 (R&R) Lexicon?

As we are also adapting to the new terminology, we have created the following cheat sheet, which may be helpful to you as well.

NIH Terminology
What’s “Out” SF424 (R&R) Terminology
What’s “In”
New (T-1) New
Competing Continuation (T-2) Renewal
Revision or Amendment Resubmission
Competing Supplement Revision
Program Announcement (PA) and/or Request for Application (RFA) Funding Opportunity Announcement (FOA)—general term for all PAs and RFAs
Principal Investigator (PI) Project Director/Principal Investigator (PD/PI)

(Combined term)
Authorized Organizational Official (AOO) or Signing Official (SO) Authorized Organizational Representative (AOR)
Other Support Current & Pending Support
Literature Cited
(Part G. of 398 Research Plan) “Bibliography & References Cited” (SF424 (R&R) Other Project Information Component
Consortium Budget Subaward Budget
Note: SF424 (R&R): Type of Application also includes “Continuation.” This is equivalent to our Progress Report or T-5.

NIH will not use the SF424 (R&R) for Progress Reports.

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9. Why Can’t I Enter the Entire Federal Wide Assurance (FWA) Number in the Human Assurances Number Field?

In the past, applicants entered on the PHS 398 all eleven alpha and numeric characters (e.g., FWA00012345).
On the SF424 “RESEARCH & RELATED Other Project Information” form, use only the numeric portion of the FWA (e.g., 00012345) as this field is limited to 10 characters (i.e., drop “FWA”)

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10. How Do I Track Page Limitations When I Have to Submit All of the Various Sections of the Research Plan as Separate PDF Files?

Separate attachments have been designed for the Research Plan sections to maximize automatic validations conducted by the eRA system. When the application is received by the agency, all of the Research Plan sections will be concatenated in the appropriate order so that reviewers and agency staff will see a single cohesive Research Plan.

While each section of the Research Plan needs to eventually be uploaded separately, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. In this way the applicant can better monitor formatting requirements such as page limits.

I suggest that you create the Research Plan in MS Word or some other word processing software; keep it to the 25 pages for Sections 2-5. Then “excise” the appropriate sections for each “Item” (2-5), and create a PDF from each excised part. There will be white space, which is fine, and expected.

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Bonus Question: Where Do I Go For Help?

For Grants.gov Registration or Submissions
If help is needed with the Grants.gov registration process or with the technical aspects of submitting through the Grants.gov system, check first the resources available at Grants.gov (http://grants.gov/).

Grants.gov help is also provided by the following office:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email support@grants.gov

For eRA Commons Registration or the eRA Commons Validation Processes
If help is needed with the eRA Commons registration process for the applicant organization and Project Directors/Principal Investigators, or with the application validation process in the eRA Commons after submission through Grants.gov, contact:

eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time
Email commons@od.nih.gov

Also visit these Web sites:
· eRA Commons: https://commons.era.nih.gov/commons/index.jsp
· eRA: http://era.nih.gov

For Help in Application Preparation:
If after reviewing the Grants.gov Application Guide SF424 (R&R) for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grants (MS Word) (PDF), help is still needed for application content preparation, contact NIH Grants Info. Grants Info may also provide information on forms transition and the overall NIH plan for electronic receipt.

Grants Info
Phone: 301-435-0714
TTY: 301-451-0088
Business Hours M-F 8:30 a.m.- 5:00 p.m. Eastern Time
Fax: 301-480-0525
Email GrantsInfo@nih.gov

For Questions about Research Programs in the NIH, CDC and FDA Awarding Components
The NIH welcomes SBIR and STTR applications from small businesses in any biomedical or behavioral research area that falls within our mission, which is to improve human health. Applicants are encouraged to subscribe to the NIH Guide for Grants and Contracts and to visit the Web sites of the NIH Institutes and Centers to learn of emerging interests and areas of high priority. For questions about research programs, contact appropriate HHS staff listed in the Awarding Component/Agency Contact Information Table (PDF or MS Word). Questions specific to particular research programs in the awarding components should be directed to the contact person listed in the funding opportunity announcement.

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