[Federal Register Volume 71, Number 156 (Monday, August 14, 2006)]
[Proposed Rules]
[Pages 46432-46434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13211]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

45 CFR PART 5b


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.

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SUMMARY: The Department of Health and Human Services proposes to alter 
System of Records, 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

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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: Comments must be received on or before September 13, 2006. 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 Record Number 09-25-0168, by any of the following methods:
     Federal eRulemaking Portal: http://regulations.gov. Follow 
the instructions for submitting comments.
     E-mail: [email protected]. Include PA SOR 
number 09-25-0168 in the subject line of the message.
     Phone: 301/496-2832 (not a toll-free number).
     Fax: 301/402-0169.
     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.

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

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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 6, 2006.
Colleen Barros,
Deputy Director for Management, NIH.
[FR Doc. E6-13211 Filed 8-11-06; 8:45 am]
BILLING CODE 4140-01-P