09-25-0168 SYSTEMS LISTING
SYSTEM NAME:
Invention, Patent, and Licensing Documents Submitted to the Public Health Service by its Employees, Grantees, Fellowship Recipients, and Contractors, HHS/NIH/OD.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Office of Technology Transfer (OTT), Office of Intramural Research, Office of the Director, 6011 Executive Boulevard, Suite 325, Bethesda, MD 20892.
Office of Financial Management (OFM), Office of the Director, Building 31, Room B1B55, 31 Center Drive, Bethesda, Maryland 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 Human Services (HHS) 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:
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:
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, Room 325, Bethesda, MD 20892.
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 requester 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.
RECORD 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.