Privacy Act of 1974; Proposed Altered System of Records, 46496-46501 [E6-13212]
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46496
Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices
Dated: July 28, 2006.
Steven Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 06–6871 Filed 8–11–06; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Treatment of Cardiovascular
Conditions With Nitrite Therapy
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: This is notice, in accordance
with 35 U.S.C. § 209(c)(1) and 37 CFR
§ (a)(1)(I), that the National Institutes of
Health (NIH), Department of Health and
Human Services (HHS), is
contemplating the grant of an exclusive
license to practice the invention
embodied in: PCT patent application
PCT/US2004/041256 filed December 9,
2004, entitled: ‘‘Methods for
Suppressing an Immune Response or
Treating a Proliferative Disorder’’ [HHS
Reference Number: E–259–2003/0–PCT–
02], to Sahajanand Medical
Technologies Pvt. Ltd., registered as a
private limited company in accordance
with the Companies Act of India, having
a principle place of business in Surat,
India and U.S. headquarters in
Gaithersburg, Maryland. The field of use
may be limited to the use of 2-(4piperazinyl)-8-phenyl-4H-1-benzopyran4-one (LY303511), for the treatment and
prevention of stenosis and restenois
and/or other proliferative disorders. The
United States of America is an assignee
of the patent rights in these inventions.
DATES: Only written comments and/or
application for a license, which are
received by the NIH Office of
Technology Transfer on or before
October 13, 2006 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Susan Carson, D. Phil, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
E-mail: carsonsu@od.nih.gov;
Telephone: (301) 435–5020; Facsimile:
(301) 402–0220.
SUPPLEMENTARY INFORMATION: The
search for specific kinase inhibitors is
an active area of drug development as
there is a continued need for effective
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anti-proliferative therapeutics with
acceptable toxicities. The core invention
is a novel method of use of one of the
4H-1-benzopyran-4-one derivatives
(LY303511) which has been shown to
target mTOR and casein kinase 2 (CK2)
without affecting P13K activity (JPET,
May 26, 2005, doi: 10.1124/
jpet.105.083550). Proof of concept data
is available in an in vivo human
zenograft PC-3 prostate tumor model,
without observed toxicity. In vitro data
suggests that (2-(4-piperazinyl)-8pheynl-4H-1 benzopyran-4-one and
derivatives may be effective in treating
inflammatory, autoimmune and other
proliferative disorders including
restenosis and a variety of cancers.
Method of use claims are directed to
derivatives of 2-(4-piperazinyl)substituted 4H-1-benzopyran-4-one
compounds as anti-proliferative,
immunosuppressive, anti-inflammatory,
anti-restenosis and anti-neoplastic
agents.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless,
within 60 days from the date of this
published Notice, NIH receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR 404.7.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: July 24, 2006
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 06–6880 Filed 8–11–06; 8:45am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Privacy Act of 1974; Proposed Altered
System of Records
National Institutes of Health
(NIH), Department of Health and Human
Services (DHHS).
ACTION: Notification of Proposed Altered
System of Records.
AGENCY:
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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: https://
regulations.gov. Follow the instructions
for submitting comments.
• E-mail:
nihprivacyactofficer@mail.nih.gov and
include PA SOR number 09–25–0168 in
the subject line of the message.
• Phone: (301) 496–2832 (not a tollfree 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.
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Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices
• 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 (301) 496–2832 (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;
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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.
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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
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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
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and licenses for these and other HHS
inventions to: (a) Scientific personnel,
both in this agency and other
Government agencies, and in nonGovernmental 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.
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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
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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.
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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)
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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
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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 nonGovernmental 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
VerDate Aug<31>2005
17:58 Aug 11, 2006
Jkt 208001
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—
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
‘‘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
E:\FR\FM\14AUN1.SGM
14AUN1
Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices
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.
[FR Doc. E6–13212 Filed 8–11–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jlentini on PROD1PC65 with NOTICES
Notice of Listing of Members of the
National Institutes of Health’s Senior
Executive Service Performance Review
Board (PRB)
The National Institutes of Health
(NIH) announces the persons who will
serve on the National Institutes of
Health’s Senior Executive Service
Performance Review Board. This action
is being taken in accordance with Title
5, U.S.C., Section 4314(c)(4), which
requires that members of performance
review boards be appointed in a manner
to ensure consistency, stability, and
objectivity in performance appraisals
and requires that notice of the
appointment of an individual to serve as
a member be published in the Federal
Register.
The following persons will serve on
the NIH Performance Review Board,
which oversees the evaluation of
performance appraisals of NIH Senior
Executive Service (SES) members:
Ms. Colleen Barros (Chair).
Dr. Norka Ruiz Bravo.
Dr. Michael Gottesman.
Dr. John Hallenbeck.
Ms. Lynn Hellinger.
Dr. Raynard Kington.
Dr. Lore Anne McNicol.
For further information about the NIH
Performance Review Board, contact the
Office of Human Resources, Workforce
Relations Division, National Institutes of
VerDate Aug<31>2005
17:58 Aug 11, 2006
Jkt 208001
Health, Building 31, Room B3C07,
Bethesda, Maryland 20892, telephone
301–402–9203 (not a toll-free number).
Dated: August 1, 2006.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. E6–13209 Filed 8–11–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of Laboratories Which
Meet Minimum Standards To Engage in
Urine Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The Department of Health and
Human Services (HHS) notifies Federal
agencies of the laboratories currently
certified to meet the standards of
Subpart C of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
April 11, 1988 (53 FR 11970), and
subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908),
on September 30, 1997 (62 FR 51118),
and on April 13, 2004 (69 FR 19644).
A notice listing all currently certified
laboratories is published in the Federal
Register during the first week of each
month. If any laboratory’s certification
is suspended or revoked, the laboratory
will be omitted from subsequent lists
until such time as it is restored to full
certification under the Mandatory
Guidelines.
If any laboratory has withdrawn from
the HHS National Laboratory
Certification Program (NLCP) during the
past month, it will be listed at the end,
and will be omitted from the monthly
listing thereafter.
This notice is also available on the
Internet at https://workplace.samhsa.gov
and https://www.drugfreeworkplace.gov.
FOR FURTHER INFORMATION CONTACT: Mrs.
Giselle Hersh or Dr. Walter Vogl,
Division of Workplace Programs,
SAMHSA/CSAP, Room 2–1035, 1 Choke
Cherry Road, Rockville, Maryland
20857; 240–276–2600 (voice), 240–276–
2610 (fax).
SUPPLEMENTARY INFORMATION: The
Mandatory Guidelines were developed
in accordance with Executive Order
12564 and section 503 of Pub. L. 100–
71. Subpart C of the Mandatory
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
46501
Guidelines, ‘‘Certification of
Laboratories Engaged in Urine Drug
Testing for Federal Agencies,’’ sets strict
standards that laboratories must meet in
order to conduct drug and specimen
validity tests on urine specimens for
Federal agencies. To become certified,
an applicant laboratory must undergo
three rounds of performance testing plus
an on-site inspection. To maintain that
certification, a laboratory must
participate in a quarterly performance
testing program plus undergo periodic,
on-site inspections.
Laboratories which claim to be in the
applicant stage of certification are not to
be considered as meeting the minimum
requirements described in the HHS
Mandatory Guidelines. A laboratory
must have its letter of certification from
HHS/SAMHSA (formerly: HHS/NIDA)
which attests that it has met minimum
standards.
In accordance with Subpart C of the
Mandatory Guidelines dated April 13,
2004 (69 FR 19644), the following
laboratories meet the minimum
standards to conduct drug and specimen
validity tests on urine specimens:
ACL Laboratories, 8901 W. Lincoln
Ave., West Allis, WI 53227, 414–328–
7840 / 800–877–7016, (Formerly:
Bayshore Clinical Laboratory).
ACM Medical Laboratory, Inc., 160
Elmgrove Park, Rochester, NY 14624,
585–429–2264.
Advanced Toxicology Network, 3560
Air Center Cove, Suite 101, Memphis,
TN 38118, 901–794–5770 / 888–290–
1150.
Aegis Analytical Laboratories, Inc., 345
Hill Ave., Nashville, TN 37210, 615–
255–2400.
Baptist Medical Center-Toxicology
Laboratory, 9601 I–630, Exit 7, Little
Rock, AR 72205–7299, 501–202–2783,
(Formerly: Forensic Toxicology
Laboratory Baptist Medical Center).
Clinical Reference Lab, 8433 Quivira
Road, Lenexa, KS 66215–2802, 800–
445–6917.
Diagnostic Services, Inc., dba DSI,
12700 Westlinks Drive, Fort Myers,
FL 33913, 239–561–8200 / 800–735–
5416.
Doctors Laboratory, Inc., 2906 Julia
Drive, Valdosta, GA 31602, 229–671–
2281.
DrugScan, Inc., P.O. Box 2969, 1119
Mearns Road, Warminster, PA 18974,
215–674–9310.
Dynacare Kasper Medical Laboratories*,
10150–102 St., Suite 200, Edmonton,
Alberta, Canada T5J 5E2, 780–451–
3702 / 800–661–9876.
ElSohly Laboratories, Inc., 5 Industrial
Park Drive, Oxford, MS 38655, 662–
236–2609.
E:\FR\FM\14AUN1.SGM
14AUN1
]]>Agencies
[Federal Register Volume 71, Number 156 (Monday, August 14, 2006)]
[Notices]
[Pages 46496-46501]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13212]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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: https://regulations.gov. Follow
the instructions for submitting comments.
E-mail: nihprivacyactofficer@mail.nih.gov and 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.
[[Page 46497]]
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 (301) 496-2832 (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
[[Page 46498]]
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
[[Page 46499]]
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
[[Page 46500]]
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
[[Page 46501]]
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.
[FR Doc. E6-13212 Filed 8-11-06; 8:45 am]
BILLING CODE 4140-01-P
