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 Office of Management and Budget
 AGENCY: Office of Management and Budget, Office of Federal Financial Management.
 ACTION: Notice of standard data elements.
 SUMMARY: The Office of Management and Budget (OMB) is establishing a standard set of data elements for a government-wide summary report of inventions and the Interagency Edison extramural invention reporting system (iEdison) as the host site for collecting this information.
 FOR FURTHER INFORMATION CONTACT: Marguerite Pridgen, Office of Federal Financial Management, Office of Management and Budget, 725 17th Street, NW., Washington, DC 20503; telephone 202-395-7844; fax 202-395-3952; e-mail 
                        *mpridgen@omb.eop.gov*.


SUPPLEMENTARY INFORMATION: I. Background On October 30, 2002, the Office of Management and Budget (OMB) proposed the establishment of a government-wide standard set of data elements for the summary report of inventions [67 FR 66178-66183]. The proposal included implementation of a standard dataset via a single interactive Internet web form. The OMB notice proposed locating this interactive web form on the Interagency Edison extramural invention reporting system (iEdison) because iEdison facilitates compliance with the Bayh-Dole Act (Pub. L. 96-517 (codified at 35 U.S.C. 200 
                    *et seq.*) Dec. 12, 1980) (“Bayh-Dole Act”) and its implementing regulations and iEdison is recognized by federal funding recipients as being used by most Federal agencies for invention reporting and tracking. In response to the 
                    **Federal Register**
                     notice, OMB received six sets of comments from eight entities: three universities; a group of universities that participate with Federal agencies in a demonstration program on research administration; one association of research universities; and three Federal agencies. The vast 
                    ( print page 59681)
                    majority of the comments relate to the implementation of the interactive Internet web form and whether Federal agencies actually need this report. Few comments addressed the content of the proposed standard data elements. This final notice establishes the data elements found in the attachment to this notice, and also establishes iEdison as the future host site for the summary report of inventions subject to addressing agency budgeting and associated implementation issues. Information on the burden associated with information collections made using these data elements will be maintained by NIH at 
                    *https://s-edison.info.nih.gov/​iEdison/​omb.jsp*. The OMB Approval Number is 0925-0001. With the data elements defined, NIH can work with other federal agencies to begin the development of the Internet web form and will consider comments related to system design (e.g., electronic submission and search capabilities) as it finalizes the implementation solution. OMB will publish proposed policy guidance after the web form is completed. The policy guidance will address only a uniform means for submitting summary reports of inventions. It will not create any new reporting requirements. The following section presents a summary of the major comments grouped by subject and our responses to them. Changes to the standard data elements are discussed in the responses to the comments. II. Comments and Responses Summary Invention Reporting Requirement *Comments:*
                     Several commenters questioned the need for an interim or final summary report of inventions. They noted that the summary report is duplicative of information contained in the standard Bayh-Dole invention reports that must be submitted to the federal agency within 60 days of the inventor disclosing the invention to the grantee/contractor. They recommended eliminating the summary report of inventions and allowing Federal program and contracting officers to have access to the more comprehensive invention reports. *Response:*
                     Both the Bayh-Dole Act and the Government-wide patent regulations issued by the Department of Commerce recognize that some Federal agencies need an interim or final summary report for proper oversight of inventions conceived or first actually reduced to practice during the term of an award (35 U.S.C. 209(d)(2); 37 CFR 401.5(f)(1) and (3)). There are two reasons some Federal agencies need this report. First, unlike the standard Bayh-Dole invention report that is only submitted when an invention is created, a summary report reflects negative reporting. Unless the grantee/contractor lists all subject inventions or states that there were none as part of the summary report, the federal agency has no way of knowing if the grantee/contractor failed to provide a Bayh-Dole invention report. Experience has shown that recipients are more actively aware of their invention reporting obligations if they are required to indicate if no inventions were made under the award. The second reason for the report is to ensure that two components of the grantee/contractor organization reconcile their records prior to closeout. Generally, Bayh-Dole reporting is undertaken by the organization's technology transfer component, and summary reporting is accomplished by the organization's Office of Sponsored Research or office of grant/contract administration. Submittal of a summary report requires that these two components reconcile their records prior to closeout, which ensures more accurate reporting. Proposed Data Elements *Comments:*
                     We received very few comments on the data elements. Specific suggestions were made to change the names of certain data elements. For example, it was suggested that the term, “Subcontractor” be changed to the more generic term, “Subawardee.” It was also suggested that we include the Dun and Bradstreet Data Universal Numbering System (DUNS) number as a means to identify the grantee, since the OMB proposed to establish the DUNS number as the universal identifier in government funding agreements. In addition, several people were confused as to whether the form could be used to report more than one invention. *Response:*
                     We agree with the recommendations to use more generic names and to include the entity's DUNS number. We believe that the template attached to the proposed notice may have been misinterpreted, because it could not adequately represent how the form would work on the web. To address any confusion regarding the reporting of multiple inventions, we changed the Group “Description” fields to clarify that a single summary report can accommodate multiple inventions, multiple patents, patent applications, plant varieties and multiple inventors per invention, patent, patent application or plant varieties. In addition, this notice makes other changes to the proposed data elements as follows: The guidance has been expanded to include the reporting of plant varieties as required by7 U.S.C. 2321 
                    *et seq.*; Plant Variety Protection Act Amendments of 1994 (7 U.S.C. 2401 note).
                The words “patent application or plant variety” have been added after the word “patent,” wherever it appears, to clarify that the awardee must report patents, patent applications and plant varieties.
                The Prime Awardee's DUNS number is added as a required element for organizations in accordance with the OMB grants management policy published in the**Federal Register**
                     on June 27, 2003 (68 FR 38402-38405).
                The Subawardee DUNS field and the Subawardee Number field are being added as required fields since the Federal Funding Accountability and Transparency Act of 2006 requires OMB to collect subawardee data (Pub. L. 109-282 (Sept. 26, 2006) (codified at 31 U.S.C. 6101 note)).
                Various “Required?” fields have been revised to clarify that the information is required for each invention, inventor, patent, patent application, and plant variety reported.
                The words “Patent Cooperation Treaty (PCT) or” have been added before “Foreign Application Filed” to clarify that this data element includes PCT applications as well as foreign patent and foreign plant variety applications (or equivalent foreign protection). The description for this field has been revised to read: “Has a PCT, foreign patent or foreign plant variety application been filed?”
                The “Foreign Countries Indicated” description has been clarified to read: “For PCT or foreign filings, have all countries been noted in the report?”
                The “Election of Title” and “Confirmatory License” fields were added as required elements to affirm the Reporting Institution's interest in the invention and the Government's interests in the reported invention are appropriately addressed consistent with the Bayh-Dole Act. Other minor clarifications, additions, and editorial changes were made. For example, the word “contract” was changed to “award” for consistency; the words “Subcontractor” and “Subcontract” were changed to “Subawardee” and “Subaward,” respectively; and the words “entire award period” were changed to “reporting period” to clarify that the reporting period may include both interim and final reporting periods. Further, the following data fields have been added as Optional elements to allow for consistency for agencies that 
                    ( print page 59682)
                    currently collect this data and those that do not: “Signatory Telephone Number” (Optional), “Signatory Email Address” (Optional), “Reporting Institution's Subawardee Name” (Optional), “Prime Awardee Organization Type Code” (Optional), “Prime Award Completion Date” (Optional), “Awarding Agency Prime Award Monitor First Name” (Optional), “Awarding Agency Prime Award Monitor Last Name” (Optional). The “Reporting Institution's Subawardee Address” and “Reporting Institution's Subawardee(s) Funding Agreement Number” fields are conditional so they are only required if the optional “Reporting Institution's Subawardee Name” is reported. Electronic Implementation of Summary Reporting of Inventions *Comments:*
                     This aspect of the proposed policy received the greatest number and variety of comments. Many commenters expressed concern over the limited value of promoting an interactive Web interface hosted on the Interagency Edison site (
                    *http://www.iEdison.gov*) as the only way to obtain and complete the proposed summary report. Specific problems with the proposed implementation include: The requirement that the summary report be signed by the organization's authorized official. The proposed notice required that the form be completed on-line, printed, signed and either faxed or sent via U.S. mail. It was suggested that there was adequate Federal precedence to use strong password authentication.
                The need to key information into an interactive Web form. Many grantee/contractor organizations have database systems and would prefer to submit the summary information as a datastream.
                The need to continue to maintain hard copies of the report.
                The compatibility of the data standard with other approved standards being implemented throughout the government. *Response:*
                     NIH will consider these issues as the interactive Web form is developed with the other agencies. The system would include electronic authentication. While an interactive Web form will not allow for the submission of a datastream directly, the intent is to have the system automatically populate fields on the form if the data has been previously entered into iEdison. The data dictionary would be reviewed to ensure compatibility with other government standards. Comments will be sought from users on a test site as soon as the Web form is developed. Applicability to Contracts *Comment:*
                     The language in the “Summary” indicates that this effort is a result of the streamlining activities under Public Law 106-107, which relate to financial assistance administration. However, other parts of the notice and the data elements themselves indicate that they apply equally to contracts. We suggest that this notice clearly specify the intent with regard to contracts. *Response:*
                     As the commenter noted, this action is the result of a financial assistance streamlining effort. When we publish a proposed notice of policy, it will specify that the policy applies only to financial assistance. However, since many agencies currently use the same summary invention reporting form for both financial assistance and procurement contracts, the workgroup followed this example and established data elements that are equally applicable to contractors so that agencies could use the report for contracts if they chose. Danny Werfel, Deputy Controller.
 Attachment: Government-Wide Standard Data Elements for Summary Reporting of Inventions Government-Wide Data Elements for Summary Reporting of Inventions These data elements are the government-wide standard set of elements for the summary reporting of all inventions, patent applications, patents and plant varieties that have been made, filed for, and/or granted using Federal funds during the term of a Federal funding agreement. The data elements include the identification of the agency source of funding, the reporting period, whether the report is an interim or final report and the name and title of the official authorized to submit the information. Any number of inventions can be reported, including the invention title, inventors' names, and invention docketing numbers and the date upon which the invention was formally reported to the funding agency consistent with Bayh-Dole regulations. A similar set of information is available for summary reporting of patent or plant variety protection applications that relate to each invention. Group
Description
Required?Document
The Document group represents data elements relevant to the entire Summary Report of Inventions
Required. Identify one only.Invention
The Invention group identifies the data elements relevant to one invention listed on this Summary Report of Inventions. The report will accommodate multiple inventions
Required if subject invention(s) are reported. May list more than one.Inventor
The Inventor group identifies the data elements relevant to one inventor for one invention listed on this Summary Report of Inventions. The report will accommodate multiple inventors per invention. In the case of a variety of plant, please use the “breeder” as the “inventor.”
Required if subject invention(s) are reported. May list more than one.Patent
The Patent group identifies the data elements relevant to one patent, patent application or plant variety, listed on this Summary Report of Inventions. The report will accommodate multiple items
Optional. May list more than one. Patent applications include new applications (provisional & non-provisional), continuations, continuations-in-part, and divisional.Patent Inventor
The Patent Inventor group identifies the data elements relevant to one inventor for one patent, patent application or plant variety listed on this Summary Report of Inventions. In the context of reporting a plant variety, please use the “breeder” as the “patent inventor.” The report will accommodate multiple inventors per patent, patent application or plant variety
At least one entry required per Patent group. May list more than one.
 Tag
Length
Description
Required?
GroupReport Type Code
1
Code specifying the type of report:
                             I = Interim. 
                             F = Final.
Required. Identify one only
Document.( print page 59683)Report Period Start Date
8
Month, day and year that the reporting period starts. Format is MMDDYYYY
Required. Identify one only
Document.Report Period End Date
8
Month, day and year that the reporting period ends. Format is MMDDYYYY
Required. Identify one only
Document.Subject Inventions Number
3
Number of subject inventions conceived of or first actually reduced to practice or the plant varieties recognized to be new, distinct, uniform and stable during the reporting period.) Valid values are 0-999
Required. Identify one only
Document.Subject Inventions Reported
1
Were all the subject inventions reported?
                             Y = Yes. 
                             N = No.
Required. Identify one only
Document.Prime Awardee Name
100
Name of the organization that has been awarded the federal funding award (e.g., grant, cooperative agreement, or contract)
Required. Identify one only
Document.Prime Awardee DUNS
15
The DUNS number of the organization that has been awarded the federal funding award
Required. Identify one only. If the Prime Awardee is an individual that does not have a DUNS number, enter 000000000
Document.Prime Award Number
30
Agency-specific number assigned to the federal funding award
Required. Identify one only
Document.Awarding Agency
100
Agency that awarded the federal funding award
Required. Identify one only
Document.Subawardee Name
100
The name of the organization submitting this Summary Report of Inventions, if different from the Prime Awardee Name
Optional. Identify one only
Document.Subawardee DUNS
15
The DUNS number of the organization submitting this Summary Report of Inventions, if different from the Prime Awardee Name
Required if Subawardee is submitting report. Identify one only. If the Subawardee is an individual that does not have a DUNS number, enter 000000000
Document.Subaward Number
30
Number assigned to the subaward in the context of this federal funding award
Optional. Identify one only
Document.Signatory Prefix
15
Prefix of the organizational official authorized to submit this report
Optional. Identify one only
Document.Signatory First Name
30
First name of the organizational official authorized to submit this report
Required. Identify one only
Document.Signatory Middle Initial
1
Middle initial of the organizational official authorized to submit this report
Optional. Identify one only
Document.Signatory Last Name
30
Last name of the organizational official authorized to submit this report
Required. Identify one only
Document.Signatory Suffix
5
Suffix of the organizational official authorized to submit this report
Optional. Identify one only
Document.Signatory Title
240
Position title of the organizational official authorized to submit this report
Required. Identify one only
Document.Signatory Telephone Number
15
Telephone number of the organizational official authorized to submit this report
Optional. Identify one only
Document.Signatory Email Address
30
Email address of the organizational official authorized to submit this report
Optional. Identify one only
Document.Report Submission Date
8
Month, day and year that this report is submitted to the Federal government. Format is MMDDYYYY
Required. Identify one only
Document.Reporting Institution's Subawardee Name
100
Name of Subawardee to organization submitting this Summary Report of Inventions (“Reporting Institution”)
Optional. May list more than one
Document.Reporting Institution's Subawardee Address
240
Address of Subawardee to organization submitting this Summary Report of Inventions
Required if “Reporting Institution's Subawardee Name” is reported. May list more than one
Document.Reporting Institution's Subawardee(s) Funding Agreement Number
50
Number assigned to the federal funding agreement to this Subawardee by the Reporting Institution
Required if “Reporting Institution's Subawardee Name” is reported. May list more than one
Document.( print page 59684)Prime Awardee Organization Type Code
1
Code specifying type of organization:
                             L = Large Business. 
                             S = Small Business. 
                             U = College/University. 
                             N = Non-profit organization. 
                             O = Other.
Optional
Document.Prime Award Completion Date
8
Month, day, and year that the award is completed. Format is MMDDYYYY
Optional
Document.Awarding Agency Prime Award Monitor First Name
30
First name of the federal agency official that monitor's the prime awardee's performance (e.g., project manager, grant monitor, or Contracting Officer's Technical Representative (COTR))
Optional
Document.Awarding Agency Prime Award Monitor Last Name
30
Last name of the federal agency official that monitors the prime awardee's performance (e.g., project manager, grant monitor, or Contracting Officer's Technical Representative (COTR))
Optional
Document.Invention Title
300
Title of the subject invention
Required if subject invention(s) are reported. Identify one only per invention
Invention.Invention Docket Number
25
Number by which the awardee tracks the subject invention
Optional. Identify one only per invention
Invention.Invention Report Date
8
Month, day and year that the subject invention is reported to the Federal government. Format is MMDDYYYY
Required if subject invention(s) are reported. Identify one only per invention
Invention.Agency Invention Number
25
Number by which the Awarding Agency tracks the subject invention
Optional. Identify one only per invention
Invention.Invention Reported by Code
1
Code specifying who reported the subject invention:
                             A = Awardee. 
                             S = Subawardee.
Optional. Identify one only per invention
Invention.Election of Title
1
Did organization elect title to invention as of the date of this report?
                             Y = Yes. 
                             N = No.
Required
Invention.Confirmatory License
1
Did organization provide funding agency with Government confirmatory license as of the date of this report?
                             Y = Yes. 
                             N = No.
Required
Invention.Inventor First Name
30
First name of the inventor of the subject invention
Required if subject invention(s) are reported. Identify one only per inventor
Inventor.Inventor Middle Name
30
Middle name of the inventor of the subject invention
Optional. Identify one only per inventor.
Inventor.Inventor Last Name
30
Last name of the inventor of the subject invention
Required if subject invention(s) are reported. Identify one only per inventor
Inventor.Patent or Patent Application Title
300
Title of the subject patent, patent application or plant variety (use variety name)
Required if the field U.S. Application Filed is Y. Identify one only per patent, patent application, or PVP
Patent.Patent ID Number
25
The patent number, patent application serial number or plant variety protection office number
Required if known. Identify one only per patent, patent application, or PVP
Patent.Patent Filing or Issue Date
8
Month, day and year that the patent application was filed, the patent was issued, or plant variety application was made. Format is MMDDYYYY
Required if the field U.S. Application Filed is Y. Identify one only per patent, patent application, or PVP
Patent.Patent Docket Number
25
Number by which the awardee tracks the subject patent, patent application, or plant variety
Optional. Identify one only per patent, patent application, or PVP
Patent.Patent Reported by Code
1
Code specifying who reported the subject patent, patent application, or plant variety:
                             A = Awardee. 
                             S = Subawardee.
Optional. Identify one only per patent, patent application, or PVP
Patent.U.S. Application Filed
1
Has a U.S. patent or U.S. plant variety protection application been filed?
                             Y = Yes. 
                             N = No.
Required. Identify one only per patent, patent application, or PVP
Patent.Patent Cooperation Treaty (PCT) or Foreign Application Filed
1
Has a PCT, foreign patent or foreign plant variety application been filed?
                             Y = Yes. 
                             N = No.
Required. Identify one only per patent, patent application, or PVP
Patent.( print page 59685)Foreign Countries Indicated
1
For PCT or foreign filings, have all countries been noted in the report?
                             Y = Yes. 
                             N = No.
Required if the field PCT or Foreign Application Filed is Y. Identify one only per patent or patent application
Patent.Patent Inventor First Name
30
First name of the inventor of the subject patent, patent application or plant variety
Required if field U.S. Application Filed is Y. Identify one only per patent inventor
Patent Inventor.Patent Inventor Middle Name
30
Middle initial of the inventor of the subject patent, patent application or plant variety
Optional. Identify one only per patent inventor
Patent Inventor.Patent Inventor Last Name
30
Last name of the inventor of the subject patent, patent application or plant variety
Required if field U.S. Application Filed is Y. Identify one only per patent inventor
Patent Inventor.


[FR Doc. E8-23902 Filed 10-8-08; 8:45 am] BILLING CODE 3110-01-P