November 19, 2005

Dear Small Business Research Community,

This is a follow-up to my October 28 th message concerning important steps you need to take if you are planning to submit for the upcoming December 1 submission date.

By now, I hope that most of you have completed (or are nearing completion) of your registration homework assignments (Grants.gov and eRA Commons).

The CCR registration step can take a few weeks, so it is so important that you start that process now if you have not already started. You can still work on the application while you are awaiting the various validations. Details for this can be found at the Grants.gov Get started webpage: http://www.grants.gov/GetStarted .

I wanted to be sure that you were aware of the following FAQs that we have made available ( http://era.nih.gov/ElectronicReceipt/faq.htm ). These are provided at the end of my message. I also wanted to share 10 tips that may be useful if you are encountering difficulties.

1. Be sure to select the “Help Mode” Icon once you download the Forms Package. It looks like this: ?
   
   This help feature contains internal instructions that are extremely helpful.
   
   
2. Be sure to select the “Next” button for forms that are multiple pages. Otherwise, you will receive an error for incompletely filling out the forms.
   
   
3. Be sure that if funds are being requested for more than one budget period, click the “Next Period” button at the top of the third budget screen (Sections F through K) to navigate to screens for the next budget period.
   
   
4. If you use Adobe as your pdf converter, the most effective way to merge files together is in Adobe, not Word.  Once you have each of your files, for example, letters, separately in PDF format,  using Adobe, open the PDF of the letter you want to appear first. Then "save as" LetterUpload.pdf or something of that kind, since you will be collecting all the other letter pdf files together at that point and saving them in this aggregate file. Then, use Acrobat's Document->Insert Pages function to append each of the other PDF files.  It's a pretty quick process once you get used to using that feature.  Then save the file again, now containing the final, aggregate result.  Attach *that* file - LetterUpload.pdf in my example - to the PureEdge form.
   
   NOTE: I am no expert on the forms, but this is the advice we have received, so I hope it makes sense and works!
   
   
5. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the name of the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered.
   
   
6. Tracking page limitations when you 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.
   
   Tip: I suggest that you create the Research Plan in Word or some other Word processing software; keep it to the 15 pages (Phase I) or 25 pages  (Phase II) for Sections 2-5. Then excise the appropriate sections for each “Item” (2-5). Create a PDF from each excised part. There will be white space, which is fine.
   
   
7. Do not be concerned that the application form has a pre-filled CFDA number that may not correspond to the Institute/Center of interest. The Center for Scientific Review will not use the CFDA number for assignment of the application. This field will be corrected by the CSR at a later time.
   
   
8. If you need help with grants.gov registration or submission, please call 1-800-518-4726. 
   
   
9. For questions on registering with the NIH Commons, please contact commons@od.nih.gov .
   
   
10. For questions related to PureEdge Forms and Applying for Grants through Grants.gov, please see http://www.grants.gov/GrantsGov_UST_Grantee/!SSL!/WebHelp/applyingforgrants.html .  (I have not been able to find a lot of information on PureEdge forms support, but this may help some).
    
    

· Why is NIH embracing electronic receipt and what are the benefits of integrating with Grants.gov's centralized website?
· What is NIH's electronic receipt goal?
· What are the expected benefits of electronic submission?
· What is Grants.gov?
· What functionality does Grants.gov provide?
· When will applicants be able to submit grant applications electronically to NIH via the Grants.gov portal?
· What is NIH's role once the applications are submitted to Grants.gov?
· Have any special provisions been made for institutions without Internet access?
· Will this system make it easier to track if an applicant is submitting duplicate applications?
· Once an application is submitted through Grants.gov, the data is configured as an SF424 (R&R) application and stored in the Grant Folder in an eRA database. Will this have any impact on the way CSR refers applications to IC Referral Offices?
· Will NIH continue to use the NIH guide to Grants and Contracts?
· What will be the minimum time that an opportunity will be announced?

Registration in Grants.gov and NIH eRA Commons

· What do I need to do before I can submit an application through Grants.gov?
· When should applicant organizations begin the registration process?
· What is involved in the Grants.gov registration process?
· What is involved in the NIH eRA Commons registration process?
· Who needs to be registered in the eRA Commons--just the Grantee Institution, the Principal Investigator (PI), or all Senior/Key Persons?
· I have an Internet Assisted Review (IAR) account. Will this satisfy the requirement for an eRA Commons account?
· How will an applicant organization know if they have successfully registered in the NIH eRA Commons?
· How does a PI know if they have been registered in the eRA Commons?
· Part of the Grants.gov process is registering in the Central Contractor Registry (CCR). What is the CCR and how will an applicant organization know if they have already registered or have successfully registered in the CCR?
· How will an applicant organization know if they are already registered or have successfully registered in Grants.gov?
· My organization already has a DUNS number. Do we need to establish a different one for Grants.gov submissions?
· Grants.gov requires a DUNS and CCR Registration. I'm also a reviewer for NIH so now I'm required to have an individual DUNS & CCR registration as well. Will I use my individual DUNS on applications and my individual CCR registration?
· NIOSH grantees will not be able to be "fully registered" in the Commons until late November. How will that affect their ability to utilize electronic submission for the Dec 15 R13 receipt date? Should they hold off on electronic submission until the April 15 receipt date?
· For consortium or subawards, do the sub-awardees need to be registered with eRA Commons and Grants.gov?

Software

· What software do I need to have loaded before I can begin using Grants.gov?
· Why does NIH use a system that is not platform independent for electronic submission?
· I have heard that Grants.gov is not Macintosh compatible. What do I do if I only use a Macintosh?

SF424 (R&R) Application

· Where is the SF424 (R&R) application guide available?
· Which form will applicants use to submit applications to NIH via Grants.gov?
· What do the new forms look like? Are samples available?
· When I download an application package from the FOA and save it for the first time locally, I get a warning message. Is there something wrong with the forms?
· What components make up the SF424 (R&R) grant package?
· How will NIH collect information contained in the PHS398 form that is not included in the SF424 (R&R) form set?
· I see that some of the application components are labeled as "PHS 398". Will the reference to the "PHS398-specific" data elements cause confusion to the applicants? Why not use "NIH"?
· There are a number of places where an attachment is uploaded. What type of attachments will NIH accept?
· Will PIs have to generate the PDFs?
· How will the scientific text of an application be submitted?
· How will appendix material be accommodated?
· Where is the budget justification located?
· Where is Other Support located?
· The SF424 (R&R) Personal Data page includes very sensitive personal data, like the Social Security Number. Is there concern about the security of such data?
· Will applicants still have the opportunity to include a cover letter?
· Will the cover letter include all the information currently allowed?
· From time-to-time new application data requirements are necessary. What will be the process to add such data elements to the SF424 (R&R) application?
· Has there been any input from the grantee community in developing the SF424 (R&R)?
· Scientific Review Administrators currently assess appendix material for appropriateness. Will this business practice be altered?
· How will supplemental material submitted after application submission be accommodated?
· Will applicants be permitted to submit supplemental material without SRA permission?
· How correctable is an application once it is submitted through Grants.gov and accepted by NIH?
· Will applicant organizations have a chance to take a look at the data once NIH has received it?
· Where will an applicant need to look to find application instructions?
· Will mechanism-specific instructions like page limitations still apply?
· How will page limitations be enforced?
· Can an applicant file using an SF 424 (R&R) for a mechanism that has not yet officially transitioned (i.e., start using SF 424 (R&R) now and stop using the PHS 398 entirely)?
· Are some of the forms being developed for training grants – institutional or individual?
· An applicant may see both detailed and modular budget component options as part of the SF424 (R&R)application package. Which should be used?
· The R&R cumulative budget page is 'automatically' filled-in by the system – correct?

Receipt Date

· What will be the receipt date--the date the application is stamped as received by Grants.gov or the date the data is received by NIH?
· What will be the status of applications that are submitted to Grants.gov and then fail the NIH eRA validations?
· What contingency plans are in place in case the Grants.gov and NIH systems have technical problems on a submission/receipt date?
· If a resubmission is required because of Grants.gov system problems, will these be considered "late"?
· If a resubmission is required because an application does not pass all validations once received in the NIH eRA Commons, will this be considered "late"?

Submission

· 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)?
· What will happen to unsolicited applications?
· Can you explain the differences in the checks that Grants.gov does on the application and those done by NIH?
· What kind of email notifications are sent to applicants by Grants.gov and by NIH during the submission process?
· I am an AOR/SO and I have received my email notification from Grants.gov but have not received any notifications from eRA Commons indicating the application has been processed. What do I do?
· An applicant often finds incorrect information after signoff. How does he resubmit a corrected application?
· If the original application comes in on the PHS398, how does a resubmission come in?
· Could you detail what will be the validations (business rules) that an application will be checked for - such as page limits?
· If applicant receives an error message because a certain section of application is missing (say Vertebrate animals) does he/she need to resubmit just that section or the entire application?
· Will the Abstract be submitted as a data element (i.e., text), or will it be a PDF? That is, will Scientific Review Administrators still be dealing with proofing abstracts that have gone through OCR?
· How does an applicant submit appendix material that cannot be transmitted electronically?
· How can a PI or a Signing Official track their application?

SBIR/STTRs

· 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)?
· My application has a prefilled CFDA number. Is this going to affect the assignment of my application?
· Is Your Small Business Registered with Grants.gov?
· Is Your Small Business and is the Project Director/Principal Investigator (PI) Registered with eRA Commons?
· 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?
· 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])?
· How Do I Find and Apply for an SBIR/STTR Funding Opportunity?
· In the SBIR/STTR application package (PA 06-006) that I downloaded from Grants.gov, the field of Opportunity Close Date is prepopulated with the closing date of Jan. 4, 2006. However, the Small Business Funding Opportunities webpage (http://grants2.nih.gov/grants/funding/sbirsttr_receipt_dates.htm) lists Dec. 1, 2005 as the submission date. Which is the correct closing date?
· Why Are There Separate FOAs for the SBIR and STTR Grant Mechanisms?
· If a Grantee Organization with the same PI wants to submit two totally separate applications under the same Funding Opportunity Announcement for the same submission date, will the validations in electronic submission allow this? Or will the system see one as merely a replacement of the other and essentially overwrite the previous application?
· An answer of "yes" to Question 8 of the SBIR/STTR Information component "Have you received SBIR Phase II awards from the Federal Government" requires an attachment explaining my company's commercialization history. How do I answer the question if I have less than 15 Phase II SBIR awards since a commercialization history is then not to be submitted?
· How does one add a key personnel that is to be hired?
· Is There A Dictionary to Help Me Understand This New SF424 (R&R) Lexicon?
· Why Can't I Enter the Entire Federal Wide Assurance (FWA) Number in the Human Assurances Number Field?
· How Do I Track Page Limitations When I Have to Submit All of the Various Sections of the Research Plan as Separate PDF Files?
· If all instructions for a research grant will be included in the application guide, what happens to the specific SBIR/STTR instructions? Will the Application Guide include the nuances of the SBIR program, or will specific SBIR instructions remain in the SBIR solicitation? Will an applicant need to sift through the information in the SF424 (R&R) instructions, the agency-specific instructions, and the instructions in the solicitation?
· What about Change of Grantee Institution applications - which application will NIH require grantees to use?
· Will non-competing progress reports be submitted through Grants.gov?
· What will happen with existing Program Announcements (PAs) and Request for Applications (RFAs)?
· What planning and thoughts are being given to distinguish SBIR submissions to grant programs versus submission to the Omnibus SBIR Contract Solicitations?
· What planning and thoughts are being given to distinguish SBIR submissions to grant programs versus submission to the Omnibus SBIR Contract Solicitations?
· Are their any future plans in regard to these contract solicitations to 1) use of SF 424 format and/or 2) for acceptance and routing through an electronic system?
· For SBIR/STTR Fast-Track, there were previously two separate applications. With SF424 (R&R), how are applicants being made aware that they must submit an integrated application, and how they might best present this “story” to the grant reviewers?
· Are special trainings being offered to SBIR/STTR review groups so that they know how to evaluate a combined application that cannot be decoupled?

Service Providers

· Who is a Service Provider?
· As I understand it, there will be more than one way for applicants to apply electronically --software that can be downloaded from Grants.gov or Service Provider software that will be specific to each provider. True?
· Could NIH recommend a particular Service Provider?
· If an applicant organization uses a Service Provider, who is responsible for completing the application, the PI, the organization, or the Service Provider?
· Where can I obtain information on service providers?
· If an applicant is using a service provider, can they print out their application or portions of their application (i.e. - the budget pages) before submission and acceptance by Grants.gov and NIH?

I wish everyone a Happy Thanksgiving.

Sincerely,

Jo Anne Goodnight
Acting Director, Office of Extramural Programs, OER, NIH, DHHS
NIH SBIR/STTR Program Coordinator
6705 Rockledge Drive
Rockledge I Building, Room 3534
Bethesda MD 20892
ph: 301-435-2688
fax: 301-480-0146
email: jg128w@nih.gov

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