E6-13212. Privacy Act of 1974; Proposed Altered System of Records

AGENCY:

National Institutes of Health (NIH), Department of Health and Human Services (DHHS).

ACTION:

Notification of Proposed Altered System of Records.

SUMMARY:

In accordance with the requirements of the Privacy Act of 1974, as amended (Privacy Act), the National Institutes of Health (NIH) hereby publishes a notice of a proposal to alter System of Records, No. 09-25-0168, “Invention, Patent, and Licensing Documents Submitted to the Public Health Service by its Employees, Grantees, Fellowship Recipients, and Contractors, HHS/NIH/OD.” NIH proposes a new legal authority for the maintenance of the System to read: 15 U.S.C. 3710, 3710a, 3710c & 3710d and 35 U.S.C. 200 et seq. provide authority to maintain the records; 37 CFR part 401 “Rights to Inventions Made by Nonprofit Organizations and Small Business Firms under Government Grants, Contracts, and Cooperative Agreements;” 37 CFR part 404 “Licensing of Government Owned Inventions;” and 45 CFR part 7 “Employee Inventions.” NIH is also proposing new routine uses for this System.

These records will be maintained by the Office of Technology Transfer (OTT), OIR/OD; Office of Financial Management (OFM), OD; Office of Reports and Analysis (ORA), OER/OD; Health and Human Services Technology Development Coordinators and HHS Contract Attorneys who retain files supplemental to the records maintained by the Office of Technology Transfer; and the Extramural Inventions and Technology Resources Branch, OPERA/OER/OD.

DATES:

The NIH invites interested parties to submit comments on or before September 13, 2006. The NIH will send a Report of the Proposed Altered System to the Congress and to the Office of Management and Budget (OMB). The proposed altered System of Records will be effective 40 days from the date submitted to the OMB, unless NIH receives comments that would result in a contrary determination.

ADDRESSES:

You may submit comments, identified by the Privacy Act System of Records Number 09-25-0168, by any of the following methods:

• Federal eRulemaking Portal: http://regulations.gov. Follow the instructions for submitting comments.
• E-mail: [e-mail] and include PA SOR number 09-25-0168 in the subject line of the message.
• Phone: [phone] (not a toll-free number).
• Fax: [phone].
• Mail: NIH Privacy Act Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, Maryland 20892.
• Hand Delivery/Courier: 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, Maryland 20892.

Comments received will be available for inspection and copying at this same address from 9 a.m. to 3 p.m., Monday through Friday, Federal holidays excepted.

FOR FURTHER INFORMATION, CONTACT:

NIH Privacy Act Officer, Office of Management Assessment (OMA), Office of the Director (OD), National Institutes of Health (NIH), 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, Maryland 20892, or telephone [phone] (not a toll-free number).

SUPPLEMENTARY INFORMATION:

The NIH proposes to alter System of Records, No. 09-25-0168, “Invention, Patent, and Licensing Documents Submitted to the Public Health Service by its Employees, Grantees, Fellowship Recipients, and Contractors, HHS/NIH/OD.” This System of Records will be used to: (1) Obtain patent protection of inventions when title is assigned to HHS; (2) monitor the development of inventions made by grantees and contractors and protect the government rights to patents made with NIH support; (3) grant licenses to HHS inventions; and (4) administer and provide royalty payments to HHS inventors.

This System of Records contains information such as inventor name, address, social security number (required if inventor is receiving royalties, otherwise optional), title and description of the invention, Employee Invention Report (EIR) Number, Case/Serial Number, prior art related to the invention, evaluation of the commercial potential of the invention, prospective licensees' intended development of the invention, associated patent prosecution and licensing documents and royalty payment information.

This System also includes other documents developed or information and material received by HHS from grantees and contractors who have reported inventions made with HHS funding, as well as HHS employee inventors who have assigned title to their inventions to HHS when HHS has applied for patents, has been granted patents, and/or is receiving royalties from patents. The records in this System may also contain reports of action taken by the agency, and decisions and reports on legal matters associated with invention, patent, and licensing matters.

This System also includes information and material received from inventors and other collaborating persons, grantees, fellowship recipients and contractors; other Federal agencies; scientific experts from non-Government organizations; contract patent counsel and their employees and foreign contract personnel; United States and foreign patent offices; prospective licensees; HHS Technology Development Coordinators; Internet and commercial databases; and third parties whom HHS contacts to determine individual invention ownership or Government ownership. These records are retrieved by name of the inventor, Employee Invention Report (EIR) Number, or keywords relating to the nature of the invention, Case/Serial Number, licensing number, internal reference numbers, contractor, agency, Institute, and/or Center.

The records in this System are stored in file folders, computer tapes, and computer disks. The records in this System will be maintained in designated NIH offices in a secure manner compatible with their content and use. During normal business hours, records at OTT are managed by on-site contractor personnel who regulate availability of the files. During evening and weekend hours the offices are locked and the building is closed. These practices are in compliance with the standards of the General Administration Manual, PHS Supplementary Chapter 45-13 “Safeguarding Records Contained in Systems of Records”; and the HHS Automated Information Systems Security Program Handbook.

Data on computer files is accessed by password known only to authorized users who are NIH or contractor employees involved in patenting and licensing of HHS inventions or in keeping records of inventions made by HHS contractors and grantees. Access to information is thus limited to those with a need to know. Data stored in computers will be accessed through the use of passwords known only to the authorized users. A password is required to access the database. All users of personal information in connection with the performance of their jobs protect information, including confidential business information submitted by potential licensees, from public view and from unauthorized personnel entering an unsupervised office.

The records in this System are retained and disposed of under the authority of the NIH Records Control Schedule contained in NIH Manual Chapter 1743, Appendix 1—“Keeping and Destroying Records” (HHS Records Management Manual, Appendix B-361), item 1100-L, which allows records to be kept for a maximum of thirty years. Refer to the NIH Manual chapter for specific disposition instructions.

The routine uses proposed for this System are compatible with the stated purpose of the System and support the agency's administration of invention, patent, and licensing programs and requirements:

The first routine use permits disclosure to a Member of Congress or to a Congressional staff member in response to an inquiry of the Congressional office made at the written request of the constituent about whom the record is maintained.

The second routine use permits the National Institutes of Health (NIH), Department of Health and Human Services (HHS; also referred to as “Department”) to disclose information from this System of Records to the Department of Justice when: (a) HHS or any component thereof; or (b) any employee of HHS in their official capacity where the Department of Justice has agreed to represent the employee; or (c) the United States Government is a party to litigation or has an interest in the litigation, and after careful review, HHS determines that the records are both relevant and necessary to the litigation and the use of the records by the Department of Justice is therefore deemed by HHS to be for a purpose that is compatible with the purpose for which HHS collected the records. Disclosure may also be made to the Department of Justice to obtain legal advice concerning issues raised by the records in this System.

The third routine use permits disclosure to a court or adjudicative body of competent jurisdiction in a proceeding when: (a) HHS or any component thereof; or (b) any employee of the agency in their official capacity; or (c) any employee of HHS in their individual capacity where HHS has agreed to represent the employee; or (d) the United States Government is party to litigation or has an interest in the litigation, and, after careful review, HHS determines that the records are both relevant and necessary to the litigation and the use of the records is therefore deemed by HHS to be for a purpose that is compatible with the purpose for which HHS collected the records.

When a record on its face, or in conjunction with other records, indicates a violation or potential violation of law, whether civil, criminal or regulatory in nature, and whether arising under general statute or particular program statute, or under regulation, rule, or order issued pursuant thereto, the fourth routine use permits disclosure to the appropriate agency, whether Federal, State, local, foreign, or tribal, or other public authority or agency responsible for enforcing, investigating or prosecuting the violation or charged with enforcing or implementing the statute, or rule, regulation, or order issued pursuant thereto, if the information disclosed is relevant to any enforcement, regulatory, investigative or prosecutive responsibility of the receiving entity.

The fifth routine use permits disclosure to a Federal, State, local, foreign, or tribal or other public authority or agency of any portion of this System of Records that contains information relevant to the retention of an employee, the retention of a security clearance, the award of a grant or contract, or the issuance or retention of a license, patent or other monetary or nonmonetary benefit. Another agency or licensing organization may make a request supported by the written consent of the individual for the entire record if it so chooses. No disclosures shall be made unless the information has been determined to be sufficiently reliable to support a referral to another office within the agency or to another Federal agency for criminal, civil, administrative, personnel, or regulatory action.

The sixth routine use permits disclosure to a Federal, State, local or foreign agency maintaining civil, criminal, or other relevant enforcement records, or other pertinent records, or to another public authority or professional organization, if necessary to obtain information relevant to an investigation concerning the retention of an employee or other personnel action, the retention of a security clearance, the award of a grant or contract, or the issuance or retention of a license, patent or other monetary or nonmonetary benefit.

Under the seventh routine use, where Federal agencies having the power to subpoena other Federal agencies' records, such as the Internal Revenue Service or the Civil Rights Commission, issue a subpoena to HHS for records in this System of Records, HHS may make those records available.

The eighth routine use permits disclosure to agency contractors, experts, or consultants who have been engaged by the agency to assist in the performance of a service related to this System of Records and who need to have access to the records in order to perform the activity. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended (Act, also referred to as “Privacy Act”), pursuant to 5 U.S.C. 552a(m).

The ninth routine use permits NIH to disclose information from this System of Records for the purpose of obtaining patent protection for HHS inventions and licenses for these and other HHS inventions to: (a) Scientific personnel, both in this agency and other Government agencies, and in non-Governmental organizations such as universities, who possess the expertise to understand the invention and evaluate its importance as a scientific advance; (b) contract patent counsel and their employees and foreign contract personnel retained by the Department for patent searching and prosecution in both the United States and foreign patent offices; (c) all other Government agencies whom HHS contacts regarding the possible use, interest in, or ownership rights in HHS inventions; (d) prospective licensees or technology finders who may further make the invention available to the public through sale or use; (e) parties, such as supervisors of inventors, whom HHS contacts to determine ownership rights, and those parties contacting HHS to determine the Government's ownership; and (f) the United States and foreign patent offices involved in the filing of HHS patent applications.

Under the tenth routine use, NIH shall report to the Treasury Department, Internal Revenue Service (IRS), as taxable income, the amount of royalty payment paid to HHS inventors.

The eleventh routine use permits NIH to disclose information from this System of Records to: (a) Potential clinical trial participants, under the rules and regulations governing the NIH human subjects protections program, when an investigator has any financial interests that might be relevant for their consideration when deciding whether or not to participate in a trial and; (b) the general public to reveal the compensation that government scientists receive on licensed inventions generated during their government work.

The following notice is written in the present tense, rather than the future tense, in order to avoid the unnecessary expenditure of public funds to republish the notice after the System has become effective.

Dated: June 9, 2006.

Colleen Barros,

Deputy Director for Management, NIH.

09-25-0168.

Security Classification:

None.

System Name:

Invention, Patent, and Licensing Documents Submitted to the Public Health Service by its Employees, Grantees, Fellowship Recipients, and Contractors, HHS/NIH/OD.

System Location:

Office of Technology Transfer (OTT), Office of Intramural Research, Office of the Director, 6011 Executive Boulevard, Suite 325, Bethesda, MD 20852.

Office of Financial Management (OFM), Office of the Director, Building 31, Room B1B55, 31 Center Drive, Bethesda, MD 20892.

Office of Reports and Analysis (ORA), Office of Extramural Research, Office of the Director, Building 1, Room 252, 1 Center Drive, Bethesda, MD 20892-2184.

Health and Humans Services Technology Development Coordinators and HHS Contract Attorneys who retain files supplemental to the records maintained by the Office of Technology Transfer.

Extramural Inventions and Technology Resources Branch, Office of Policy for Extramural Research Administration (OPERA), Office of Extramural Research, Office of the Director, Rockledge I, Room 1040, 6705 Rockledge Drive, Bethesda, MD 20892-7980.

Write to the System Manager below for office locations.

Categories Of Individuals Covered By The System:

HHS grantees and contractors who have reported inventions made with HHS funding, as well as HHS employee inventors who have assigned title to their inventions to HHS when HHS has applied for patents, has been granted patents, and/or is receiving royalties from patents.

Categories Of Records In The System:

This System of Records contains information such as inventor name, address, social security number (required if inventor is receiving royalties, otherwise optional), title and description of the invention, Employee Invention Report (EIR) Number, Case/Serial Number, prior art related to the invention, evaluation of the commercial potential of the invention, prospective licensees' intended development of the invention, associated patent prosecution and licensing documents and royalty payment information.

This System also includes other documents developed or information and material received by HHS from grantees and contractors who have reported inventions made with HHS funding, as well as HHS employee inventors who have assigned title to their inventions to HHS when HHS has applied for patents, has been granted patents, and/or is receiving royalties from patents. The records in this System may also contain reports of action taken by the agency, and decisions and reports on legal matters associated with invention, patent, and licensing matters.

This System also includes information and material received from inventors and other collaborating persons, grantees, fellowship recipients and contractors; other Federal agencies; scientific experts from non-Government organizations; contract patent counsel and their employees and foreign contract personnel; United States and foreign patent offices; prospective licensees; HHS Technology Development Coordinators, Internet and commercial databases, and third parties whom HHS contacts to determine individual invention ownership or Government ownership. These records are retrieved by name of the inventor, Employee Invention Report (EIR) Number, or keywords relating to the nature of the invention, Case/Serial Number, licensing number, internal reference numbers, contractor, agency, Institute, and/or Center.

The records in this System are stored in file folders, computer tapes, and computer disks. The records in this System will be maintained in designated NIH offices in a secure manner compatible with their content and use. During normal business hours, records at OTT are managed by on-site contractor personnel who regulate availability of the files. During evening and weekend hours the offices are locked and the building is closed. These practices are in compliance with the standards of the General Administration Manual, PHS Supplementary Chapter 45-13 “Safeguarding Records Contained in Systems of Records”; and the HHS Automated Information Systems Security Program Handbook.

Data on computer files is accessed by password known only to authorized users who are NIH or contractor employees involved in patenting and licensing of HHS inventions or in keeping records of inventions made by HHS contractors and grantees. Access to information is thus limited to those with a need to know. Data stored in computers will be accessed through the use of passwords known only to the authorized users. A password is required to access the database. All users of personal information in connection with the performance of their jobs protect information, including confidential business information submitted by potential licensees, from public view and from unauthorized personnel entering an unsupervised office.

Authority For Maintenance Of The System:

15 U.S.C. 3710, 3710a, 3710c & 3710d and 35 U.S.C. 200 et seq. provide authority to maintain the records; 37 CFR Part 401 “Rights to Inventions Made by Nonprofit Organizations and Small Business Firms under Government Grants, Contracts, and Cooperative Agreements;” 37 CFR Part 404 “Licensing of Government Owned Inventions;” and 45 CFR Part 7 “Employee Inventions.”

Purpose(S) Of The System:

Records in this System are used to: (1) Obtain patent protection of inventions when title is assigned to HHS; (2) monitor the development of inventions made by grantees and contractors and protect the government rights to patents made with NIH support; (3) grant licenses to HHS inventions; and (4) administer and provide royalty payments to HHS inventors.

Routine Uses Of Records Maintained In The System, Including Categories Of Users And The Purposes For Which The Records May Be Used:

The routine uses proposed for this System are compatible with the stated purpose of the System and support the agency's administration of invention, patent, and licensing programs and requirements:

1. Disclosure may be made to a Member of Congress or to a Congressional staff member in response to an inquiry of the Congressional office made at the written request of the constituent about whom the record is maintained.

2. The Department of Health and Human Services (HHS; also referred to as “Department”) may disclose information from this System of Records to the Department of Justice when: (a) HHS or any component thereof; or (b) any employee of HHS in their official capacity where the Department of Justice has agreed to represent the employee; or (c) the United States Government is a party to litigation or has an interest in the litigation, and after careful review, HHS determines that the records are both relevant and necessary to the litigation and the use of the records by the Department of Justice is therefore deemed by HHS to be for a purpose that is compatible with the purpose for which HHS collected the records. Disclosure may also be made to the Department of Justice to obtain legal advice concerning issues raised by the records in this System.

3. Disclosure may be made to a court or adjudicative body of competent jurisdiction in a proceeding when: (a) HHS or any component thereof; or (b) any employee of the agency in their official capacity; or (c) any employee of HHS in their individual capacity where HHS has agreed to represent the employee; or (d) the United States Government is party to litigation or has an interest in the litigation, and, after careful review, HHS determines that the records are both relevant and necessary to the litigation and the use of the records is therefore deemed by HHS to be for a purpose that is compatible with the purpose for which HHS collected the records.

4. When a record on its face, or in conjunction with other records, indicates a violation or potential violation of law, whether civil, criminal or regulatory in nature, and whether arising under general statute or particular program statute, or under regulation, rule, or order issued pursuant thereto, disclosure may be made to the appropriate agency, whether Federal, State, local, foreign or tribal, or other public authority or agency responsible for enforcing, investigating or prosecuting the violation or charged with enforcing or implementing the statute, or rule, regulation, or order issued pursuant thereto, if the information disclosed is relevant to any enforcement, regulatory, investigative or prosecutive responsibility of the receiving entity.

5. Disclosure may be made to a Federal, State, local, foreign, or tribal or other public authority or agency of any portion of this System of Records that contains information relevant to the retention of an employee, the retention of a security clearance, the award of a grant or contract, or the issuance or retention of a license, patent or other monetary or nonmonetary benefit. Another agency or licensing organization may make a request supported by the written consent of the individual for the entire record if it so chooses. No disclosures shall be made unless the information has been determined to be sufficiently reliable to support a referral to another office within the agency or to another Federal agency for criminal, civil, administrative, personnel, or regulatory action.

6. Disclosure may be made to a Federal, State, local or foreign agency maintaining civil, criminal, or other relevant enforcement records, or other pertinent records, or to another public authority or professional organization, if necessary to obtain information relevant to an investigation concerning the retention of an employee or other personnel action, the retention of a security clearance, the award of a grant or contract, or the issuance or retention of a license, patent or other monetary or nonmonetary benefit.

7. Where Federal agencies having the power to subpoena other Federal agencies' records, such as the Internal Revenue Service or the Civil Rights Commission, issue a subpoena to HHS for records in this system of records, HHS may make those records available.

8. Disclosure may be made to agency contractors, experts, or consultants who have been engaged by the agency to assist in the performance of a service related to this System of Records and who need to have access to the records in order to perform the activity. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended (Act, also referred to as “Privacy Act”), pursuant to 5 U.S.C. 552a(m).

9. NIH may disclose information from this System of Records for the purpose of obtaining patent protection for HHS inventions and licenses for these and other HHS inventions to: (a) Scientific personnel, both in this agency and other Government agencies, and in non-Governmental organizations such as universities, who possess the expertise to understand the invention and evaluate its importance as a scientific advance; (b) contract patent counsel and their employees and foreign contract personnel retained by the Department for patent searching and prosecution in both the United States and foreign patent offices; (c) all other Government agencies whom HHS contacts regarding the possible use, interest in, or ownership rights in HHS inventions; (d) prospective licensees or technology finders who may further make the invention available to the public through sale or use; (e) parties, such as supervisors of inventors, whom HHS contacts to determine ownership rights, and those parties contacting HHS to determine the Government's ownership; and (f) the United States and foreign patent offices involved in the filing of HHS patent applications.

10. NIH shall report to the Treasury Department, Internal Revenue Service (IRS), as taxable income, the amount of royalty payment paid to HHS inventors.

11. NIH may disclose information from this System of Records to: (a) Potential clinical trial participants, under the rules and regulations governing the NIH human subjects protections program, when an investigator has any financial interests that might be relevant for their consideration when deciding whether or not to participate in a trial and; (b) the general public to reveal the compensation that government scientists receive on licensed inventions generated during their government work.

Policies And Practices For Storing, Retrieving, Accessing, Retaining, And Disposing Of Records In The System:

Storage:

The records in this System are stored in file folders, computer tapes, and computer disks.

Retrievability:

Records are retrieved by name of the inventor, Employee Invention Report (EIR) Number, or keywords relating to the nature of the invention, Case/Serial Number, licensing number, internal reference numbers, contractor, agency, Institute, and/or Center.

Safeguards:

1. Authorized Users: Data on computer files is accessed by password known only to authorized users who are NIH or contractor employees involved in patenting and licensing of HHS inventions or in keeping records of inventions made by HHS contractors and grantees. Access to information is thus limited to those with a need to know.

2. Physical Safeguards: The records in this System will be maintained in designated NIH offices in a secure manner compatible with their content and use. During normal business hours, records at OTT are managed by on-site contractor personnel who regulate availability of the files. During evening and weekend hours the offices are locked and the building is closed. These practices are in compliance with the standards of the General Administration Manual, PHS Supplementary Chapter 45-13 “Safeguarding Records Contained in Systems of Records”; and the HHS Automated Information Systems Security Program Handbook.

3. Procedural and Technical Safeguards: Data stored in computers will be accessed through the use of passwords known only to the authorized users. A password is required to access the database. All users of personal information in connection with the performance of their jobs (see Authorized Users, above) protect information, including confidential business information submitted by potential licensees, from public view and from unauthorized personnel entering an unsupervised office.

Retention And Disposal:

Records are retained and disposed of under the authority of the NIH Records Control Schedule contained in NIH Manual Chapter 1743, Appendix 1—“Keeping and Destroying Records” (HHS Records Management Manual, Appendix B-361), item 1100-L, which allows records to be kept for a maximum of thirty years. Refer to the NIH Manual Chapter for specific disposition instructions.

System Manager(S) And Address:

Freedom of Information Act Coordinator, Office of Technology Transfer, Office of Intramural Research, Office of the Director, 6011 Executive Boulevard, Suite 325, Bethesda, MD 20852.

Office of Financial Management, Office of Management, Office of the Director, 2115 E. Jefferson Street, Room 3A-307, Rockville, MD 20892.

Office of Reports and Analysis, Office of Extramural Research, Office of the Director, Building 1, Room 252, 1 Center Drive, Bethesda, MD 20892-2184.

Extramural Inventions and Technology Resources Branch, Office of Policy for Extramural Research Administration, Office of Extramural Research, Office of the Director, Rockledge I, 6705 Rockledge Drive, Room 1040, Bethesda, MD 20892-7980.

Notification Procedures:

To determine if a record exists, write to the System Manager listed above. A requestor must also verify their identity by providing either a notarization of the request or a written certification that the requestor is who he or she claims to be and understands that the knowing and willful request for acquisition of a record pertaining to an individual under false pretenses is a criminal offense under the Act, subject to a five thousand dollar fine. The request should include: (a) Full name, and (b) appropriate identifying information on the nature of the invention.

Records Access Procedure:

Write to the System Manager specified above to attain access to records and provide the same information as is required under the Notification Procedures. Requesters should also reasonably specify the contents of the records being sought. Individuals may also request an accounting of disclosure of their records, if any.

Contesting Record Procedure:

Contact the System Manager specified above and reasonably identify the record, specify the information to be contested, the corrective action sought, and your reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely or irrelevant. The right to contest records is limited to information which is incomplete, irrelevant, incorrect, or untimely (obsolete).

Record Source Categories:

Inventors and other collaborating persons, grantees, fellowship recipients and contractors; other Federal agencies; scientific experts from non-Government organizations; contract patent counsel and their employees and foreign contract personnel; United States and foreign patent offices; prospective licensees; HHS Technology Development Coordinators, Internet and commercial databases, and third parties whom HHS contacts to determine individual invention ownership or Government ownership.

Systems Exempted From Certain Provisions Of The Act:

None.