Starting with the current submission cycle, which ends 5 February 2007, the National Institutes of Health (NIH) requires for the first time that applicants submit proposals for its R01 research grants in electronic, rather than paper, form. This article--Part 1 of a 2-part series--provides some background and explains the process NIH has devised for submitting electronic R01 applications and the key steps researchers and grant administrators need to take before the February deadline.
One of those steps is registering your organization and key personnel for electronic grant applications. If you have not yet started the registration process (explained below), you need to start NOW because it can take 2 to 4 weeks.
Part 2 of the series , which will appear on 12 January, looks at NIH’s preparations and the preparations of four universities as the 5 February deadline gets closer.
In 1999, when Congress passed the Federal Financial Assistance Management Improvement Act (also known as Public Law 106-107 ), the government had some 600 domestic grant programs--as noted in the law itself--and nearly as many processes for applying for and managing grants, each with its own forms and terminology. In the 1990s, new Web-based technologies were enabling electronic commerce in the manufacturing and financial services sectors. Public Law 106-107 directed federal agencies to use these new technologies to make its grant processes simpler and more uniform.
One visible result of the law is a new central federal grants resource, Grants.gov . Grants.gov allows potential applicants to search for federal grant opportunities using common search terms via a single user interface. Since late 2003, all major federal agencies offering grants have been required to post their funding announcements on Grants.gov; all have complied.
Public Law 106-107 also requires the government to provide a common format and technology for applying for and managing federal grants. Grants.gov acts as a front end for all the federal agencies that make grants, providing a uniform format and security protocols for the core grant application, and routing applications to the appropriate agencies. This increase in uniformity, however, comes at a cost: All federal grant applicants must now contend not just with the agency they are applying to, but also with Grants.gov.
First steps: Registration of organizations and individuals
Grants.gov is now the initial recipient of electronic R01 (and other) applications, even if the eventual recipient is NIH. Another change is that in most cases designated representatives of the institution--NOT the principal investigator (PI)--will be the ones sending in the grants. The good news for researchers is that they will be relieved of some of the headaches of assembling and submitting grant applications. But because your career may depend on the outcome of these applications, it's a good idea to learn the details of the process and how you can help to make it work.
Organizations applying for grants must register for electronic-submission at both Grants.gov and at NIH. During registration, institutions specify the key players and are issued an electronic signature, called a credential, which is used to secure transactions involving Grants.gov. If your institution has submitted electronic grant applications to NIH for other types of funding, it may already be registered with Grants.gov and NIH. Check the current list of NIH institutional registrants  to find out. Even if your organization is fully registered, you still may need to register individual PIs; more about that later.
If your institution has not gone through the process already, registering an organization with Grants.gov is a four-step process:
1. Acquiring a DUNS number
The DUNS (Data Universal Numbering System)  number is a common way of identifying companies and not-for-profit organizations. Creditors have long used DUNS numbers, issued by Dun & Bradstreet (D&B), to check the credit-worthiness of new customers. Since the DUNS number is a unique identifier, it has become a common way of identifying organizations in electronic commerce, including federal grant transactions.
Because DUNS numbers are familiar in financial transactions, most institutions already have them. If your institution needs a DUNS number, D&B can issue a DUNS number  quickly and for free.
2. Listing with the Central Contractor Registry
The next step is to get listed with the government’s Central Contractor Registry  (CCR). Your institution’s DUNS number is required for this part of the registration, along with a number of business and financial details including your institution's bank and bank account numbers (for electronic funds transfers). CCR spells out these requirements in an online registration handbook .
CCR and Grants.gov say CCR registration takes about 2 days to process. One result of CCR registration is the assignment of a Marketing Partner ID Number or MPIN, which is needed later in the registration process. Those who have gone through CCR registration caution that once the MPIN is assigned, it is not easily retrieved from CCR, so whoever is doing the registration should immediately (and securely) record it.
CCR registration--The downside
The government’s Central Contractor Registry is public, for many good reasons. But having one’s telephone number and e-mail on a public list means it can be accessed by e-mail spammers and cold-calling sales people. This is a problem recognized by CCR, but there are some partial solutions. Registrants should enter central switchboard telephone numbers and nonpersonal (e.g., email@example.com ) e-mail addresses to minimize the annoyance.
3. Acquiring an electronic credential
An electronic credential acts as the signature identifying your organization in an e-business transaction. Grants.gov uses a contractor, Operational Research Consultants (ORC), to verify and validate the identity of the organizations registering with Grants.gov. Institutions need to provide their DUNS numbers and have their CCR registration completed in order to register with ORC .
Once your organization has completed this step, ORC provides a username and password. Grants.gov says that this takes a day or less. With a username and password from ORC, an institution can complete registration with Grants.gov (step 4).
4. Registering the E-Business Point of Contact (POC) and Authorized Organization Representative (AOR)
During registration with Grants.gov, institutions specify the people authorized to transact business electronically on the institution’s behalf. The E-business Point of Contact (POC) is a senior official who has binding authority to commit the institution to contracts--for example the institution’s vice-president for research or chief financial officer.
The Authorized Organization Representatives (AOR) is the person who submits the grant application and represents the institution in subsequent interactions with the agency about the grant application. This is not the PI. At institutions with a small volume of federal grants, the POC and AOR may be the same person.
The POC (or a designee) must register the institution with Grants.gov by logging in , providing the DUNS number and MPIN, and assigning one or more employees of the organization as AORs. Once they have been designated, AORs can submit electronic grant applications. Grants.gov says AOR registration takes 1 to 2 days. Unless the POC doubles as an AOR, the POC will have little direct involvement in grants applications beyond this point.
To apply for an NIH grant, institutions also need to register with NIH, and although NIH registration has only two stages, it usually takes longer than the Grants.gov process. NIH has established a central informational resource center for grant applications called the Electronic Research Administration (ERA) Commons . This is where institutions register with NIH. The ERA Commons is a password-protected area of the NIH Web site where grant applicants can check the status of grant applications and provide follow-up submissions (e.g., reference letters and financial data). It also provides guidance and training for researchers and research administrators on the electronic submission process.
This registration task can get confusing because NIH uses different terminology than Grants.gov. The person Grants.gov calls the AOR is, in NIH-speak, the Signing Official (SO). The SO designates the Project Director or Principal Investigator (PD or PI) on a grant application. If a grant application is funded, the PD/PI leads the subsequent research work.
Registering with NIH has two steps:
1. Institutional identification
NIH’s first registration step requires completing an online form  that identifies the institution and AOR/SO, as well as, optionally, an account administrator. This stage requires e-mail verification and a hard-copy fax that captures the AOR/SO’s physical signature.
As mentioned previously, NIH provides a public list  of organizations already registered, giving their DUNS numbers and Institutional Profile (IPF) codes. When an institution registers, the NIH system captures that information in an Institutional Profile and assigns a unique identifier--the IPF code--to the profile.
If your institution is already registered, it will be listed here and you can skip this step. As of December 2006, more than 8000 organizations had signed up.
2. PI identification
The AOR/SO also has responsibility for registering PIs in their organization with ERA Commons--the second stage of the NIH registration process. NIH requires PIs to be associated with an institution, and as long as a PI is registered under an institution, that PI can be assigned to any grant application filed by that institution. This step includes creating a personal profile for the PI analogous to the institutional profile created when an institution registers.
Once registered, PIs can access their accounts and update their personal profiles. Registered PIs can also check on the status of their current grant applications.
As noted at the beginning, NIH says that ERA Commons registration can take 2 to 4 weeks. Institutions that have not already done so should start NOW to complete the Grants.gov and NIH/ERA Commons registration steps in order to make the 5 February 2007 deadline.
Choosing the delivery method
The official name of the federal government-wide research grant application is Standard Form 424, Application for Federal Assistance (Research and Related), abbreviated to SF-424 (R&R). NIH accepts these electronic documents three different ways. Research administrators will need to decide which method suits their institutions.
1. Web-based forms
Research administrators or PIs can fill out the SF-424 (R&R) forms online through a Web-based application  hosted by Grants.gov. Users of this method first need to download a special software package from Grants.gov. The software, called PureEdge, acts as a viewer of funding announcements posted on Grants.gov and also as a system for completing the form. One nice feature of this arrangement is that PureEdge automatically fills in some of the blanks on the form, taking the data from the funding announcement.
Another advantage of this approach is that the display indicates any additional forms and attachments required by the announcement. Be sure to thoroughly read and understand all of the forms and documents identified by the funding announcement. Forms labeled “optional” in the SF-424 (R&R) package may still be required by NIH for certain programs; "optional" doesn't always mean "optional." Check with NIH well before the submission deadline if you aren't sure whether a form or document is required for the program you're applying to.
Apple/Macintosh, Linux, and other non-Windows users have one more hurdle: PureEdge is made for Windows machines only. To use the PureEdge software, non-Windows platforms need to access a separate server  with software that converts the Mac and other formats to Windows-compatible data. Grants.gov recently added a Mac version of PureEdge that can skip the separate server, but this software is still in an early release and Grants.gov warns users of its limitations.
Research grant proposals often require sending attachments. Attachments sent through Grants.gov --including those for NIH proposals--need to be in Adobe’s Portable Document Format (PDF). The PDF-reader software that often comes bundled with computer systems does NOT create PDF files; you need separate software to generate PDF files. Grants.gov offers a list of some PDF software and third-party conversion services on its software page . This listing, the page notes, does not constitute an endorsement.
All PDF software are not created equal
When using a third-party software package or service for file-format conversions, such as to create PDF documents, you either have to take on faith claims that the software works with NIH and Grants.gov or get the benefit of others' experiences. NIH’s guidelines on PDF attachments  say that the conversion package CutePDF  has worked for most applicants. That, of course, does not mean other third-party Windows packages will not work. Apple Macintosh users have the PDF file format built-in on their systems as standard equipment. A source familiar with NIH’s electronic grant application program says that PDF attachments generated by Macs have worked so far as well.
Here’s another hint about PDF conversions. When creating a PDF file, keep the file name simple and use characters valid in World Wide Web URLs: basic alphanumeric characters (A-Z, 0-9) and avoid special characters like ampersands (&), slashes (/ \), or brackets.
You can always double-check on the quality of the conversions by viewing the assembled grant image in ERA Commons. See the section “Submitting the application” below.
2. System-to-system delivery
An alternative to the PureEdge forms is system-to-system delivery , which sends data directly (and securely) to Grants.gov. With the system-to-system option, organizations exchange data in a predefined eXtensible Markup Language (XML) format instead of using the PureEdge forms as an intermediate step. As with the PureEdge solution, initial grant applications are sent to Grants.gov, but subsequent interactions with ERA Commons--such as correction notices or tracking requests and responses--flow directly between the institution and NIH.
System-to-system delivery makes sense mainly for institutions with a high volume of federal grant applications since the system requires considerable planning and system design and development. Some of the third-party services (see the next section) offer system-to-system delivery as well. The transactions use a set of secure e-business protocols  based on internationally-recognized  e-business standards. Thus, if an institution invests in system-to-system delivery with NIH, it can likely use the same technology with other agencies, or even for e-business transactions other than grants.
If you are a researcher, check with your research administrators to see if system-to-system delivery is being planned or developed and how the development schedule and processes may affect your work.
3. Outside software or service provider
Another option for institutions is to use third-party software or a service provider to capture the data in the grant application and transmit it to Grants.gov. NIH provides a list of companies  offering these services, which range from stand-alone software packages to hosted Web-based applications.
For example, several of the services offer browser-based data input that removes the need for the PureEdge software--and claim to support multiple computing platforms better than Grants.gov. To institutions that need to support multiple computing platforms, this could be an important factor.Other services provide PDF conversion for attachments. Still other services provide system-to-system delivery as outlined above. In some cases, the software or services are part of larger grants-management packages.
The point of all this, of course, is to deliver a grant application--via form SF-424 (R&R)--to NIH. Three versions of the form (labeled 1, 2, and 2a) are currently in use. Funding announcements issued before 15 June 2006 use version 1 of the application until they expire or are reposted
Funding announcements issued after 15 June 2006 use either version 2 or 2a. Don’t worry about choosing the right form; the system takes of that. When you click on the gray Apply for Grant Electronically button on an NIH funding announcement issued after 15 June 2006, the download page posted on Grants.gov indicates in the Competition ID field the form to use: “Version-2-Forms” or “Version-2A-Forms.” Don't confuse the gray button with the link labeled "Grants.gov/Apply for Grants,” which leads to a generic instruction page on the Grants.gov site.
As of 15 September 2006, there were still a few exceptions--programs that require version 1--but these are small business grants (SBIR/STTR) and some Agency for Healthcare Research and Quality R13 programs. These exceptions are listed in an NIH notice .
The SF-424 (R&R) form has seven parts and captures details about the project, its staff, and its budget. For PIs and research administrators who have submitted grant applications before, many of the data items in the SF-424 (R&R) will be familiar; they are similar to items in the paper form PHS398. For those familiar with the previous form, NIH offers a mapping  from items in the old PHS398 to their counterparts in the new SF-424 (R&R).
Researchers and research administrators familiar with NIH know that the agency entertains R01 proposals from the science community that are not submitted in response to any specific funding announcement. Beginning in February 2007, these unsolicited proposals must also use the prescribed electronic delivery methods. Since all electronic submissions must be connected to a funding announcement, NIH has established “parent” funding announcements  (R01 and others) that electronic grant applications can reference. The "parent" program announcement for unsolicited R01 grant applications is PA-07-070 . Clicking on the Apply for Grant Electronically button generates a Grants.gov page for downloading the appropriate form in the PureEdge format.
Remember, however, that the form SF-424 (R&R) is used for research grant applications government-wide. NIH also collects data specific to its needs, which are not covered in the government-wide SF-424 (R&R). NIH calls these agency-specific data elements “PHS398 components” since they represent items that were carried in the old PHS398 forms but are not included in the SF-424 (R&R). These components are separate forms submitted with the SF-424 (R&R) that include the cover letter file, cover letter supplement, research plan, modular budget, and checklist.
Again, it's important to review carefully each funding announcement and make sure to provide all the forms and documents the announcement asks for, whether they are labeled “mandatory” or “optional” for electronic transmission.
NIH provides extensive documentation  including detailed guides to the SF-424 (R&R) form--about 200 pages--as well as sample forms, application examples, tips, FAQs, and a training video.
Submitting the application
Picture yourself as the AOR/SO: You’ve registered with Grants.gov and ERA Commons, filled out all the required forms, made PDF documents for all attachments--and you are still within the deadline. So now what ? If you use the PureEdge software to prepare the application, the software can do a preliminary error-check. This review will make sure you have all of the required government-wide (but not necessarily all the required NIH-specific) forms. When the error-check is completed the SEND button appears. OK, go for it.
Assuming you have a live Internet connection, the software connects with Grants.gov and presents you with a log-in screen requiring your AOR/SO username and password. Remember: Only the AOR/SO (or someone signing in as the AOR/SO) can submit grant applications. Upon log-in, Grants.gov returns a receipt with a tracking number and date-time stamp. This receipt is just an acknowledgement that Grants.gov received the grant application. It does not imply that it is free of errors or that NIH has accepted it. That comes later.
Within 48 hours, the AOR/SO should receive an e-mail from Grants.gov with either a validation or a rejection. If Grants.gov finds no failures to comply with its requirements, it forwards the document to the recipient agency. Grants.gov then sends e-mails to the AOR/SO saying the grant application has been forwarded to NIH, and a subsequent e-mail indicating the grant application has been retrieved by NIH.
ERA Commons assembles the grant application into a single grant image that combines the data in the SF-424 (R&R), entries in the NIH-specific PHS398 components, and the PDF attachments. At this point, ERA Commons performs a second error-check, this one dealing with NIH-specific requirements. AOR/SOs and PIs will receive e-mail notices from ERA Commons with error or warning messages--or indicating that the application has cleared, error-free. NIH notes that e-mail can be unreliable, so AOR/SOs and PIs are encouraged to log in to their ERA Commons accounts to check the status of that review. The ERA Commons system will return one or more notifications giving the status of the application and noting any discrepancies or omissions that the applicants need to fix.
If you have submitted grant applications before, as a researcher or research administrator, you no doubt recognize that getting ready for these new processes will require significant changes by both NIH and research institutions. In part 2 of the series , we look at NIH’s preparations for electronic R01 applications and learn about the plans of four research universities, who also share their experiences with earlier electronic grant applications to NIH.
Alan Kotok is managing editor of Science Careers and author of three books on electronic business.
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