Privacy Act of 1974; System of Records Notice, 2747-2752 [2020-00633]
Download as PDF
Federal Register / Vol. 85, No. 11 / Thursday, January 16, 2020 / Notices
New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD
20993–0002 or the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Gregory Reaman, Oncology Center of
Excellence, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2202, Silver Spring,
MD 20993–0002, 301–796–0785; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Pediatric Study Plans for Oncology
Drugs: Questions and Answers.’’ This
draft guidance provides information
regarding the submission of an iPSP, as
required by section 505B(e) of the FD&C
Act (21 U.S.C. 355c(e)), for oncology
drugs only. When finalized, this draft
guidance will provide FDA’s current
thinking regarding iPSPs for oncology
drugs in light of the amendments to
section 505B of the FD&C Act (also
referred to as the Pediatric Research
Equity Act, or PREA) made by section
504 of FDARA (Pub. L. 115–52). This
draft guidance does not contain a
complete discussion of general
requirements for development of drugs
for pediatric use under PREA or section
505A of the FD&C Act (21 U.S.C. 355a)
(also referred to as the Best
Pharmaceuticals for Children Act or
BPCA (Pub. L. 107–109)).
Section 504 of FDARA amended
section 505B of the FD&C Act to
require—for original applications
submitted on or after August 18, 2020—
pediatric investigations of certain
targeted cancer drugs with new active
ingredients, based on molecular
mechanism of action rather than clinical
indication. FDARA thus created a
mechanism to require evaluation of
certain novel medicines that may have
the potential to address an unmet
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medical need in the pediatric
population. Timely investigation in
children of the antitumor activity of
potentially effective targeted drugs
under development in adults and of
those drugs’ toxicities relative to the
unique growth and developmental
considerations of pediatric patients, is
intended to accelerate early pediatric
evaluation of these products and
ultimately facilitate development of
appropriate new therapies for pediatric
patients.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Pediatric Study Plans for Oncology
Drugs: Questions and Answers.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3521). The collections
of information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001. The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: January 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00592 Filed 1–15–20; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Early
Diagnosis and Prediction.
Date: February 13, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Nijaguna Prasad, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, National
Institutes of Health, 7201 Wisconsin Avenue,
Gateway Building, Suite 2W200, Bethesda,
MD 20892, (301) 496–9667,
nijaguna.prasad@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: January 10, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–00577 Filed 1–15–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Privacy Act of 1974; System of
Records Notice
National Institutes of Health
(NIH), Department of Health and Human
Services (HHS).
ACTION: Notice of a modified system of
records and rescindment of a system of
records notice.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
SUMMARY:
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Federal Register / Vol. 85, No. 11 / Thursday, January 16, 2020 / Notices
as amended, the Department of Health
and Human Services (HHS) through the
National Institutes of Health (NIH) is
modifying system of records 09–90–
0067 to reflect that the records are now
maintained by NIH, the Food and Drug
Administration (FDA), and the Centers
for Disease Control and Prevention
(CDC) and to rename the system of
records ‘‘Invention, Patent, and
Licensing Documents Related to
Inventions By Public Health Service
Employees, Grantees, Fellowship
Recipients, and Contractors.’’ In
addition, HHS/NIH is rescinding a
related NIH system of records, 09–25–
0168.
The modified system of records
is effective February 18, 2020, with the
exception of the new and revised
routine uses. The new and revised
routine uses will be effective 30 days
after publication of this notice, unless
comments are received that warrant a
revision to this notice. Comments
should be submitted within 30 days of
publication, but may be made at any
time.
DATES:
You may submit comments,
identified by the Privacy Act system of
records number 09–90–0067, by any of
the following methods:
• Federal eRulemaking Portal: https://
regulations.gov. Follow the instructions
for submitting comments.
• Email: celeste.dade-vinson@nih.gov
and include the system of records
number, 09–90–0067, in the subject line
of the message.
• Phone: (301) 402–6201.
• Fax: (301) 402–0169.
• Mail: NIH Privacy Act Officer,
Office of Management Assessment,
National Institutes of Health, 6011
Executive Blvd., Suite 601, MSC 7669,
Rockville, MD 20892.
• Hand Delivery/Courier: 6011
Executive Blvd., Suite 601, MSC 7669,
Rockville, MD 20892.
Comments received will be available
for inspection and copying at this same
address from 9:00 a.m. to 3:00 p.m.,
Monday through Friday, federal
holidays excepted.
FOR FURTHER INFORMATION CONTACT:
General questions about the modified
system of records may be submitted by
mail or telephone to: Celeste DadeVinson, NIH Privacy Act Officer, Office
of Management Assessment (OMA),
Office of the Director (OD), National
Institutes of Health (NIH), 6011
Executive Blvd., Suite 601, MSC 7669,
Rockville, MD 20892, telephone number
(301) 402–6201 (not a toll-free number).
SUPPLEMENTARY INFORMATION:
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ADDRESSES:
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I. Modifications to System of Records
09–90–0067
This system of records was
established in 1979 or earlier (see 44 FR
58144, at 58164) by HHS’ Office of
General Counsel which managed the
records until approximately 1993, when
that responsibility was transferred to
NIH and NIH established related system
of records 09–25–0168 (see 58 FR
45111). Until fiscal year (FY) 2017, NIH
managed all records on behalf of the
relevant Public Health Service (PHS)
components (NIH, FDA, and CDC)
whose funding, employment, or other
activities give rise to the records.
Starting in FY 2017, records related to
an invention arising in FY 2017 or later
that is associated with only one PHS
component are managed by that
component, and NIH now manages only
the following records for other
components: (i) Records related to
inventions that arose prior to FY 2017,
and (ii) records related to joint
inventions associated with more than
one component. Consequently, HHS has
decided to update the department-level
system of records notice (SORN) 09–90–
0067 to cover all three components’
records to avoid the need for multiple
component-specific SORNs, and to
rescind NIH SORN 09–25–0168.
The modifications to SORN 09–90–
0067 include the following substantive
changes, in addition to formatting
changes required by OMB Circular A–
108 and minor wording changes
throughout the SORN:
• The system name has been changed
from ‘‘Invention Reports Submitted to
the Department of Health and Human
Services by its Employees, Grantees,
Fellowship Recipients, and Contractors’’
to ‘‘Invention, Patent, and Licensing
Documents Related to Inventions By
Public Health Service Employees,
Grantees, Fellowship Recipients, and
Contractors.’’
• The ‘‘System Location’’ and
‘‘System Manger(s)’’ sections now
provide contact information for each
relevant PHS component (NIH, FDA,
and CDC) instead of for OGC.
• The ‘‘Authorities’’ section, which
formerly cited only 45 CFR parts 6, 7,
and 8 and Executive Orders (E.O.s) 9865
and 10096, no longer cites 45 CFR parts
6 and 8 but now cites many additional
authorities which were cited in NIH
SORN 09–25–0168, plus these
additional authorities which were not
cited in that SORN: 42 U.S.C. secs. 241,
282, and 284; 37 CFR part 401; and 15
U.S.C. 3701–3708.
• The ‘‘Categories of Records’’ section
now identifies more categories than just
invention reports and includes the list
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of data elements that was in NIH SORN
09–25–0168, updated to include
employing office or organization name
and address, email address, phone, and
fax numbers, status as Fellow or
contract employee, educational
degree(s), and citizenship, and to
remove Social Security Number (SSN).
SSN is needed only by HHS finance
offices, to disburse royalty payments to
an inventor; records used for
disbursement and related functions are
covered under another system of records
(e.g., 09–90–0024 HHS Financial
Management System Records).
• The ‘‘Purposes’’ section, which
previously stated: ‘‘To maintain the
information and patent records for the
entire Department,’’ now includes the
four purposes described in NIH SORN
09–25–0168 (now numbered as 1, 2, 3,
and 7) and three additional purposes (4,
5, and 6).
• The ‘‘Record Source Categories’’
section now includes these additional,
broadened, or updated categories: Other
inventors, co-inventors, collaborating
persons; grantees, fellowship recipients
and contractors; other federal agencies;
United States and foreign patent offices;
prospective licensees; PHS technology
development coordinators; internet and
commercial databases; and third parties
who PHS contacts to determine
individual invention ownership or
government ownership.
• The ‘‘Routine Uses’’ section has
been modified as follows:
Æ It includes nine new routine uses
(1, 4, 5, 6, 7, 8, 10, 11, and 14; however,
closely similar versions of 5 and 10
were in NIH SORN 09–25–0168).
Æ It includes three revised routine
uses:
—Routine use 2: This routine use,
which authorizes disclosures to a
congressional office when responding
to its inquiries regarding constituent
requests, has been reworded to
include the word ‘‘written’’ in
describing the constituents’ requests
and the congressional office’s
inquiries.
—Routine use 3: Two previously
separate litigation-related routine uses
are now combined in routine use 3.
—Routine use 9: Six previously separate
routine uses (which were combined in
one routine use in NIH SORN 09–25–
0168 but divided in subparts
numbered a. through f.) are now
combined in routine use 9 and
divided in subparts numbered a.
through f.
Æ Two breach response-related
routine uses which were published for
all HHS systems of records on February
14, 2018 (see 83 FR 6591) as required by
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OMB Memorandum M–17–12 are now
numbered as 12 and 13.
Æ Five routine uses which were in
NIH SORN 09–25–0168 (numbered as 4,
5, 6, 7, and 10 in that SORN) have not
been included in modified SORN 09–
90–0067 because the disclosures they
described would be made by other
systems of record or otherwise are no
longer needed for this system of records.
• The ‘‘Storage’’ section has been
updated to include electronic media and
to list types of portable devices that
could be used, with prior HHS approval,
to access and store system records.
• The ‘‘Safeguards’’ section has been
updated to list additional safeguards
which are now used to protect records
from unauthorized access (e.g., privacy
and security documents and training,
encryption, smart cards, biometrics,
firewalls, and intrusion detection).
• The ‘‘Retention’’ section, which
previously reflected that records are
maintained onsite for the life of the
patent (17 years) or for 7 years if the
invention was not patented, and are
then stored offsite at a federal records
center (without indicating when they
would be destroyed), now states that,
currently, all records are retained in
accordance with a NIH disposition
schedule which provides for records to
be retained for a maximum of 30 years,
and that, if required, separate schedules
will be developed for the records
managed by FDA and CDC in FY 2017
or later.
• The ‘‘Record Access Procedures,’’
‘‘Contesting Record Procedures,’’ and
‘‘Notification Procedures’’ sections now
provide more detailed instructions for
making a sufficiently specific request
and now also include identity
verification requirements.
II. Rescindment of NIH System of
Records Notice (SORN) 09–25–0168
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As modified, the department-level
SORN 09–90–0067 now includes
updated descriptions of the same NIH
records that are covered in NIH SORN
09–25–0168. Accordingly, HHS is
rescinding NIH SORN 09–25–0168 as
duplicative of modified SORN 09–90–
0067.
Dated: January 9, 2020.
Alfred C. Johnson,
Deputy Director for Management, National
Institutes of Health.
SYSTEM NAME AND NUMBER:
Invention, Patent, and Licensing
Documents Related to Inventions By
Public Health Service Employees,
Grantees, Fellowship Recipients, and
Contractors, 09–90–0067.
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SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
The address of each agency
component responsible for the system of
records is as shown in the System
Manager(s) section.
SYSTEM MANAGER(S):
The System Managers are as follows:
• For NIH invention records, joint
invention records, and records related to
inventions that arose prior to FY 2017:
National Institutes of Health, Director,
Office of Technology Transfer, Office of
Intramural Research, Office of the
Director, 6011 Executive Blvd., Suite
325, Rockville, MD 20892–7660, nihott@
mail.nih.gov, (301) 496–7057.
• For FDA invention records related
to inventions that arose in FY 2017 or
later: Food and Drug Administration,
Director, FDA Technology Transfer
Program, Office of the Chief Scientist,
10903 New Hampshire Ave., Silver
Spring, MD 20993, techtransfer@
fda.hhs.gov.
• For CDC invention records related
to inventions that arose in FY 2017 or
later: Centers for Disease Control and
Prevention, Associate Director for
Science, Office of Technology and
Innovation, 1600 Clifton Rd. NE, M/S
D–42, Atlanta GA 30329–4018, TTO@
cdc.gov, (404) 639–1330.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
15 U.S.C. secs. 3701–3710d, National
Technology Transfer and Advancement
Act; 35 U.S.C. secs. 200–212, Patent
Rights in Inventions Made with Federal
Funding Assistance; 42 U.S.C. secs. 241,
282 and 284, the Public Health Service
Act; Executive Order (E.O.) 9865,
Providing for the Protection Abroad of
Inventions Resulting from Research
Financed by the Government; and E.O.
10096, Providing for a Uniform Patent
Policy for the Government with Respect
to Inventions made by Government
Employees and for the Administration
of Such Policy. See also 37 CFR parts
401 and 404, and 45 CFR part 7.
PURPOSE(S) OF THE SYSTEM:
The records are maintained and used
by HHS for these purposes:
1. To obtain patent protection for
inventions reported by Public Health
Service (PHS) employees, inventors,
contractors, and non-profit and
educational institutions to which title is
owned or co-owned by the Federal
Government.
2. To grant licenses to patents
obtained through the invention reports.
3. To provide royalty payments to the
relevant PHS employees, inventors,
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contractors, and non-profit and
educational institutions.
4. To manage all assets of the
technology transfer process (i.e.,
marketing, statistics, technology
abstracts).
5. To refer to for information needed
during award processing, querying, and
reporting.
6. To share relevant information with
other HHS offices that manage grants,
contracts, or personnel associated with
the invention, including any
information needed to investigate
matters such as possible law, contract,
or grant agreement violations and issues
concerning an individual’s or entity’s
suitability or eligibility for federal
employment, contracts, grants, licenses,
or other federal benefits. Records used
by other HHS offices for such purposes,
if retrieved by personal identifier,
would be covered under other Systems
of Records Notices (SORNs); see, for
example, OPM/GOVT–3 covering
Adverse Action Files, 09–90–0020
covering Suitability for Employment
Records, and 09–90–0100 covering Civil
and Administrative Investigative Files
of the Inspector General.
7. To provide documentation needed
for related financial management and
debt collection functions, including
effecting disbursements of royalty
awards and payments by the
Department of the Treasury (Treasury),
coordinating with Treasury to recover
any improper payments or other claims
through offsets against federal salary
and tax refund payments, and reporting
royalty payments and uncollectible debt
amounts to the Internal Revenue Service
(IRS) as income. Records used for
financial management and debt
collection purposes are covered under
other HHS System of Records Notices
(SORNs); see, e.g., HHS SORN Nos. 09–
90–0024 HHS Financial Management
System Records and 09–40–0012 Debt
Management and Collection System for
descriptions of purposes for which such
records are used within HHS and
routine uses for which such records may
be disclosed to the Department of
Treasury and other parties outside HHS.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
The records are about inventors; i.e.,
any individual involved in the
development of an NIH, FDA, or CDC
technology who reported an invention,
applied for a patent, was granted a
patent, and/or is receiving royalties
from a patent to which title is owned or
co-owned by the Federal Government or
by a grantee, fellowship recipient, or
contractor of the Federal Government.
The inventor may be a PHS (or other
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HHS) employee, extramural grantee,
fellowship recipient, independent
contractor, or other outside inventor or
co-inventor.
CATEGORIES OF RECORDS IN THE SYSTEM:
The records consist of invention
reports, patent prosecution and
licensing documents (such as patent
applications and license agreements)
and related documents, containing all
information necessary to be included in
such documents, for all individuals who
contributed to the invention. Applicable
data elements may include: Inventor
name, job title, employing office or
organization name and address, contact
information (mailing and email
addresses, phone numbers, and fax
numbers), HHS employee identification
number or other unique identifier,
inventor’s status as a fellow or contract
employee, educational degree(s),
citizenship, title and description of the
invention, Employee Invention Report
(EIR) number, license number (if an
agreement provides for royalties to be
paid by a third party), number assigned
to submitted invention report, case/
serial number, prior art related to the
invention, evaluation of the commercial
potential of the invention, prospective
licensees’ intended development of the
invention, and royalty payment
information.
RECORD SOURCE CATEGORIES:
Sources of information about
inventors contained in these records
include the subject individual (i.e.,
inventor); other inventors, co-inventors,
and 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;
PHS technology development
coordinators; internet and commercial
databases; and third parties who PHS
contacts to determine individual
invention ownership or government
ownership.
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ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
THE PURPOSES OF SUCH USES:
In addition to other disclosures
authorized directly in the Privacy Act at
5 U.S.C. 552a(b)(4) through (11),
information about an inventor may be
disclosed from this system of records to
following parties outside of HHS
without the individual’s prior written
consent, for these purposes:
1. HHS may make the inventor’s name
and other information public, when
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making information about the invention
public. For example, HHS makes the
inventor’s name public in the Federal
Register and/or on the internet when it
lists inventions that are available for
collaboration and/or licensing (i.e., to
seek parties interested in licensing the
invention or in undertaking
collaborative research activities to
further develop, evaluate, or
commercialize the invention), and when
publicizing results of agency research
activities. Information made public
without the inventor’s prior, written
consent would be limited to information
that HHS would be required to release
to a requester under the Freedom of
Information Act (FOIA); meaning,
information that would not result in a
clearly unwarranted invasion of privacy.
2. Disclosure may be made to a
congressional office from the record of
an individual in response to a written
inquiry from the congressional office
made at the written request of the
individual.
3. A record may be disclosed to the
Department of Justice (DOJ) or to a court
or other tribunal in litigation or other
proceedings when: (a) HHS, or any
component thereof; (b) any HHS
employee in his/her official capacity; (c)
any HHS employee in his/her
individual capacity where the DOJ (or
HHS, where it is authorized to do so)
has agreed to represent the employee; or
(d) the United States Government, is a
party to the proceeding or has a direct
and substantial interest in the
proceeding and, by careful review, HHS
determines that the records are both
relevant and necessary to the
proceeding.
4. Records may be disclosed to
authorized federal agencies, programs,
or other entities for purposes of program
evaluation and assessment, including
quality assurance or peer review, audit,
or accreditation activities.
5. Information may be disclosed to
federal agencies and HHS contractors,
grantees, consultants, or volunteers who
have been engaged by HHS to assist in
accomplishment of an HHS function
relating to the purposes of this system
of records and need to have access to
the records in order to assist HHS. Any
contractor will be required to comply
with the requirements of the Privacy Act
of 1974, as amended.
6. Information about an inventor may
be included in information disclosed to
an awardee or contractor entity in
connection with the performance,
administration, or evaluation of its
contract under the conditions of the
particular award or contract.
7. Information about an inventor may
be included in contractor past
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performance information disclosed to a
federal agency upon request.
8. As prescribed in HHS regulations,
HHS may disclose system information
to qualified experts not within the
definition of HHS employees in order to
obtain their advice about patent,
licensing, and other issues involved in
the transfer, among agencies, of
scientific and technical discoveries.
9. HHS may disclose information from
this system of records for the purpose of
obtaining patent protection for HHS
inventions and licenses 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 HHS 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
Federal Government’s ownership; and,
f. The United States and foreign
patent offices involved in the filing of
HHS patent applications.
10. Disclosure may be made to: (a)
Potential clinical trial participants,
consistent with the rules and
regulations governing the HHS human
subjects protections program, when
informing the participants of an
investigator’s financial interests that
might be relevant for their consideration
when deciding whether or not to
participate in a trial (i.e., if the financial
interests include interests in an
invention); and (b) the general public to
reveal summary-level compensation that
government scientists receive, under 15
U.S.C. 3710c, on licensed inventions
generated during their government
work.
11. HHS may disclose information to
the National Archives and Records
Administration (NARA), General
Services Administration (GSA), or other
relevant federal agencies pursuant to
records management inspections
conducted under the authority of 44
U.S.C. 2904 and 2906.
12. A record may be disclosed to
appropriate agencies, entities, and
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Federal Register / Vol. 85, No. 11 / Thursday, January 16, 2020 / Notices
persons when (1) HHS suspects or has
confirmed that there has been a breach
of the system of records; (2) HHS has
determined that as a result of the
suspected or confirmed breach there is
a risk of harm to individuals, HHS
(including its information systems,
programs, and operations), the Federal
Government, or national security; and
(3) the disclosure made to such
agencies, entities, and persons is
reasonably necessary to assist in
connection with HHS’s efforts to
respond to the suspected or confirmed
breach or to prevent, minimize, or
remedy such harm.
13. A record may be disclosed to
another federal agency or federal entity,
when HHS determines that information
from this system of records is
reasonably necessary to assist the
recipient agency or entity in (1)
responding to a suspected or confirmed
breach or (2) preventing, minimizing, or
remedying the risk of harm to
individuals, the recipient agency or
entity (including its information
systems, programs, and operations), the
Federal Government, or national
security, resulting from a suspected or
confirmed breach.
14. Records may be disclosed to the
Department of Homeland Security
(DHS) if captured in an intrusion
detection system used by HHS and DHS
pursuant to a DHS cybersecurity
program that monitors internet traffic to
and from federal government computer
networks to prevent a variety of types of
cybersecurity incidents.
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:
Records are stored in electronic media
(including, with prior approval, on
approved portable/mobile devices such
as laptops, tablets, PDAs, USB drives,
media cards, portable hard drives,
Blackberrys, Smartphones, CDs, DVDs,
and/or other mobile storage devices)
and in paper form.
POLICIES AND PRACTICES FOR RETRIEVAL OF
RECORDS:
Records are retrieved by inventor
name or identifying number (for
example, the NIH Enterprise Directory
or NED ID number).
khammond on DSKJM1Z7X2PROD with NOTICES
POLICIES AND PROCEDURES FOR RETENTION AND
DISPOSAL OF RECORDS:
Currently, all records are retained and
disposed of in accordance with NIH
records disposition schedule N1–443–
10–1 and NIH Manual Chapter 1743,
Keeping and Destroying Records,
Appendix 1, item 1100–L, which
provides for records to be kept for a
maximum of thirty years. In the event
that separate disposition schedules are
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required for records managed by FDA
and CDC in FY 2017 or later, HHS will
submit disposition schedules for
approval by the National Archives and
Records Administration (NARA) to
cover those records.
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
SAFEGUARDS:
Measures to prevent unauthorized
disclosures are implemented as
appropriate for each location or form of
storage and for the types of records
maintained. Safeguards conform to the
HHS Information Security and Privacy
Program, https://www.hhs.gov/ocio/
securityprivacy/. Site(s) implement
personnel and procedural safeguards
such as the following:
• Authorized Users: Access is strictly
limited to authorized personnel whose
official duties require such access (i.e.,
valid, business need to know).
• Administrative Safeguards:
Controls to ensure proper protection of
information and information technology
systems include, but are not limited to,
the completion of a Security Assessment
and Authorization (SA&A) package and
a Privacy Impact Assessment (PIA) and
mandatory completion of annual
Information Security and Privacy
Awareness training. The SA&A package
consists of a Security Categorization,
e-Authentication Risk Assessment,
System Security Plan, evidence of
Security Control Testing, Plan of Action
and Milestones (if applicable),
Contingency Plan, and evidence of
Contingency Plan Testing. When the
design, development, or operation of a
system of records is performed by a
contractor to accomplish an agency
function, the applicable Privacy Act
Federal Acquisition Regulation (FAR)
clauses are inserted in solicitations and
contracts.
• Technical Safeguards: Controls that
are generally executed by the computer
system and are employed to minimize
the possibility of unauthorized access,
use, or dissemination of the data in the
system include, but are not limited to,
user identification, password protection,
firewalls, virtual private network,
encryption, intrusion detection system,
common access cards, smart cards,
biometrics and public key
infrastructure.
• Physical Safeguards: Controls to
secure the data and protect paper and
electronic records, buildings, and
related infrastructure against threats
associated with their physical
environment include, but are not
limited to, the use of the HHS Employee
ID and/or badge number and key cards,
security guards, cipher locks, biometrics
and closed-circuit TV. Paper records are
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Sfmt 4703
2751
secured in locked file cabinets, offices
and facilities. Electronic media are kept
on secure servers or computer systems.
Records are stored in a dedicated file
room or in locking file cabinets in file
folders. During normal business hours,
assigned agency personnel, including
Records Management staff and on-site
contractor personnel, regulate
availability of the files. During evening
and weekend hours the offices are
locked.
RECORD ACCESS PROCEDURES:
An individual who wishes to access a
record about him or her in this system
of records must submit a written request
to the relevant System Manager,
reasonably specify the record sought,
and include (a) the inventor’s full name
and address, (b) the approximate date(s)
the information was submitted, (c) the
type(s) of information collected, and (d)
the office(s) or official(s) responsible for
the collection of information. In
addition, the requester must verify his
or her 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 of a
record pertaining to an individual under
false pretenses is a criminal offense
under the Privacy Act, subject to a fine
of up to five thousand dollars.
Individuals may also request an
accounting of disclosures that have been
made of any records about them.
CONTESTING RECORD PROCEDURES:
Records that contain factually
incorrect information may be contested.
To contest information in a record about
you, write to the relevant System
Manager; provide the same information
described under ‘‘Record Access
Procedures,’’ including identity
verification information; and specify the
information which is contested, the
corrective action sought, and the
reason(s) for requesting the correction,
along with supporting information. The
right to contest records is limited to
information which is factually
inaccurate, incomplete, irrelevant, or
untimely (obsolete).
NOTIFICATION PROCEDURES:
An individual who wishes to know if
this system of records contains a record
about him or her must write to the
relevant System Manager and provide
the same information described under
‘‘Record Access Procedures,’’ including
identity verification information.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
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Federal Register / Vol. 85, No. 11 / Thursday, January 16, 2020 / Notices
HISTORY:
47 FR 45514 (Oct. 13, 1982), 59 FR
55845 (Nov. 9, 1994), 83 FR 6591 (Feb.
14, 2018).
NOTICE OF RESCINDMENT:
The following system of records is
rescinded as duplicative of system 09–
90–0067:
SYSTEM NAME AND NUMBER:
Invention, Patent, and Licensing
Documents Submitted to the Public
Health Service by its Employees,
Grantees, Fellowship Recipients, and
Contractors, 09–25–0168.
HISTORY:
71 FR 46496 (Aug. 14, 2006), 83 FR
6591 (Feb. 14, 2018).
[FR Doc. 2020–00633 Filed 1–15–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
khammond on DSKJM1Z7X2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Clinical Management of Patients in
Community-Based Settings Study Section.
Date: February 10–11, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz Carlton Hotel, 1150 22nd Street
NW, Washington, DC 20037.
Contact Person: Lauren Fordyce, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214,
Bethesda, MD 20892, (301) 827–8269,
fordycelm@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Collaborative Clinical Studies of Mental
Illness.
Date: February 11, 2020.
Time: 1:15 p.m. to 2:00 p.m.
VerDate Sep<11>2014
17:49 Jan 15, 2020
Jkt 250001
Agenda: To review and evaluate grant
applications.
Place: Lorien Hotel & Spa, 1600 King
Street, Alexandria, VA 22314.
Contact Person: Serena Chu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3178,
MSC 7848, Bethesda, MD 20892, 301–500–
5829, sechu@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Immunology
AREA Review.
Date: February 12, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Liying Guo, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4016F
Bethesda, MD 20892, 301–435–0908, lguo@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Urology and
Urogynecology.
Date: February 13, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Julia Spencer Barthold,
MD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, 301–402–3073, julia.barthold@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Cellular and Molecular Biology of Complex
Brain Disorders.
Date: February 13–14, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Canopy by Hilton, 940 Rose Avenue,
North Bethesda, MD 20852.
Contact Person: Afia Sultana, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Room 4189, Bethesda, MD
20892, (301) 827–7083, sultanaa@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Genomics,
Computational Biology and Technology.
Date: February 13, 2020.
Time: 10:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Christopher Payne, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, 301–402–3702,
christopher.payne@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
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Fmt 4703
Sfmt 4703
Development of Appropriate Pediatric
Formulations and Pediatric Drug Delivery
Systems.
Date: February 14, 2020.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Paek-Gyu Lee, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4201,
MSC 7812, Bethesda, MD 20892, (301) 613–
2064, leepg@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: January 10, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–00578 Filed 1–15–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HHS–NIH–CDC SBIR PHS
2020–1 Topic 85: Broad spectrum antibody
against human enteroviruses.
Date: February 10, 2020.
Time: 9:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Yong Gao, Ph.D., Scientific
Review Officer, Scientific Review Program,
Division of Extramural Activities, National
E:\FR\FM\16JAN1.SGM
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Agencies
[Federal Register Volume 85, Number 11 (Thursday, January 16, 2020)]
[Notices]
[Pages 2747-2752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00633]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Privacy Act of 1974; System of Records Notice
AGENCY: National Institutes of Health (NIH), Department of Health and
Human Services (HHS).
ACTION: Notice of a modified system of records and rescindment of a
system of records notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974,
[[Page 2748]]
as amended, the Department of Health and Human Services (HHS) through
the National Institutes of Health (NIH) is modifying system of records
09-90-0067 to reflect that the records are now maintained by NIH, the
Food and Drug Administration (FDA), and the Centers for Disease Control
and Prevention (CDC) and to rename the system of records ``Invention,
Patent, and Licensing Documents Related to Inventions By Public Health
Service Employees, Grantees, Fellowship Recipients, and Contractors.''
In addition, HHS/NIH is rescinding a related NIH system of records, 09-
25-0168.
DATES: The modified system of records is effective February 18, 2020,
with the exception of the new and revised routine uses. The new and
revised routine uses will be effective 30 days after publication of
this notice, unless comments are received that warrant a revision to
this notice. Comments should be submitted within 30 days of
publication, but may be made at any time.
ADDRESSES: You may submit comments, identified by the Privacy Act
system of records number 09-90-0067, by any of the following methods:
Federal eRulemaking Portal: https://regulations.gov. Follow
the instructions for submitting comments.
Email: [email protected] and include the system
of records number, 09-90-0067, in the subject line of the message.
Phone: (301) 402-6201.
Fax: (301) 402-0169.
Mail: NIH Privacy Act Officer, Office of Management
Assessment, National Institutes of Health, 6011 Executive Blvd., Suite
601, MSC 7669, Rockville, MD 20892.
Hand Delivery/Courier: 6011 Executive Blvd., Suite 601,
MSC 7669, Rockville, MD 20892.
Comments received will be available for inspection and copying at
this same address from 9:00 a.m. to 3:00 p.m., Monday through Friday,
federal holidays excepted.
FOR FURTHER INFORMATION CONTACT: General questions about the modified
system of records may be submitted by mail or telephone to: Celeste
Dade-Vinson, NIH Privacy Act Officer, Office of Management Assessment
(OMA), Office of the Director (OD), National Institutes of Health
(NIH), 6011 Executive Blvd., Suite 601, MSC 7669, Rockville, MD 20892,
telephone number (301) 402-6201 (not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Modifications to System of Records 09-90-0067
This system of records was established in 1979 or earlier (see 44
FR 58144, at 58164) by HHS' Office of General Counsel which managed the
records until approximately 1993, when that responsibility was
transferred to NIH and NIH established related system of records 09-25-
0168 (see 58 FR 45111). Until fiscal year (FY) 2017, NIH managed all
records on behalf of the relevant Public Health Service (PHS)
components (NIH, FDA, and CDC) whose funding, employment, or other
activities give rise to the records. Starting in FY 2017, records
related to an invention arising in FY 2017 or later that is associated
with only one PHS component are managed by that component, and NIH now
manages only the following records for other components: (i) Records
related to inventions that arose prior to FY 2017, and (ii) records
related to joint inventions associated with more than one component.
Consequently, HHS has decided to update the department-level system of
records notice (SORN) 09-90-0067 to cover all three components' records
to avoid the need for multiple component-specific SORNs, and to rescind
NIH SORN 09-25-0168.
The modifications to SORN 09-90-0067 include the following
substantive changes, in addition to formatting changes required by OMB
Circular A-108 and minor wording changes throughout the SORN:
The system name has been changed from ``Invention Reports
Submitted to the Department of Health and Human Services by its
Employees, Grantees, Fellowship Recipients, and Contractors'' to
``Invention, Patent, and Licensing Documents Related to Inventions By
Public Health Service Employees, Grantees, Fellowship Recipients, and
Contractors.''
The ``System Location'' and ``System Manger(s)'' sections
now provide contact information for each relevant PHS component (NIH,
FDA, and CDC) instead of for OGC.
The ``Authorities'' section, which formerly cited only 45
CFR parts 6, 7, and 8 and Executive Orders (E.O.s) 9865 and 10096, no
longer cites 45 CFR parts 6 and 8 but now cites many additional
authorities which were cited in NIH SORN 09-25-0168, plus these
additional authorities which were not cited in that SORN: 42 U.S.C.
secs. 241, 282, and 284; 37 CFR part 401; and 15 U.S.C. 3701-3708.
The ``Categories of Records'' section now identifies more
categories than just invention reports and includes the list of data
elements that was in NIH SORN 09-25-0168, updated to include employing
office or organization name and address, email address, phone, and fax
numbers, status as Fellow or contract employee, educational degree(s),
and citizenship, and to remove Social Security Number (SSN). SSN is
needed only by HHS finance offices, to disburse royalty payments to an
inventor; records used for disbursement and related functions are
covered under another system of records (e.g., 09-90-0024 HHS Financial
Management System Records).
The ``Purposes'' section, which previously stated: ``To
maintain the information and patent records for the entire
Department,'' now includes the four purposes described in NIH SORN 09-
25-0168 (now numbered as 1, 2, 3, and 7) and three additional purposes
(4, 5, and 6).
The ``Record Source Categories'' section now includes
these additional, broadened, or updated categories: Other inventors,
co-inventors, collaborating persons; grantees, fellowship recipients
and contractors; other federal agencies; United States and foreign
patent offices; prospective licensees; PHS technology development
coordinators; internet and commercial databases; and third parties who
PHS contacts to determine individual invention ownership or government
ownership.
The ``Routine Uses'' section has been modified as follows:
[cir] It includes nine new routine uses (1, 4, 5, 6, 7, 8, 10, 11,
and 14; however, closely similar versions of 5 and 10 were in NIH SORN
09-25-0168).
[cir] It includes three revised routine uses:
--Routine use 2: This routine use, which authorizes disclosures to a
congressional office when responding to its inquiries regarding
constituent requests, has been reworded to include the word ``written''
in describing the constituents' requests and the congressional office's
inquiries.
--Routine use 3: Two previously separate litigation-related routine
uses are now combined in routine use 3.
--Routine use 9: Six previously separate routine uses (which were
combined in one routine use in NIH SORN 09-25-0168 but divided in
subparts numbered a. through f.) are now combined in routine use 9 and
divided in subparts numbered a. through f.
[cir] Two breach response-related routine uses which were published
for all HHS systems of records on February 14, 2018 (see 83 FR 6591) as
required by
[[Page 2749]]
OMB Memorandum M-17-12 are now numbered as 12 and 13.
[cir] Five routine uses which were in NIH SORN 09-25-0168 (numbered
as 4, 5, 6, 7, and 10 in that SORN) have not been included in modified
SORN 09-90-0067 because the disclosures they described would be made by
other systems of record or otherwise are no longer needed for this
system of records.
The ``Storage'' section has been updated to include
electronic media and to list types of portable devices that could be
used, with prior HHS approval, to access and store system records.
The ``Safeguards'' section has been updated to list
additional safeguards which are now used to protect records from
unauthorized access (e.g., privacy and security documents and training,
encryption, smart cards, biometrics, firewalls, and intrusion
detection).
The ``Retention'' section, which previously reflected that
records are maintained onsite for the life of the patent (17 years) or
for 7 years if the invention was not patented, and are then stored
offsite at a federal records center (without indicating when they would
be destroyed), now states that, currently, all records are retained in
accordance with a NIH disposition schedule which provides for records
to be retained for a maximum of 30 years, and that, if required,
separate schedules will be developed for the records managed by FDA and
CDC in FY 2017 or later.
The ``Record Access Procedures,'' ``Contesting Record
Procedures,'' and ``Notification Procedures'' sections now provide more
detailed instructions for making a sufficiently specific request and
now also include identity verification requirements.
II. Rescindment of NIH System of Records Notice (SORN) 09-25-0168
As modified, the department-level SORN 09-90-0067 now includes
updated descriptions of the same NIH records that are covered in NIH
SORN 09-25-0168. Accordingly, HHS is rescinding NIH SORN 09-25-0168 as
duplicative of modified SORN 09-90-0067.
Dated: January 9, 2020.
Alfred C. Johnson,
Deputy Director for Management, National Institutes of Health.
SYSTEM NAME AND NUMBER:
Invention, Patent, and Licensing Documents Related to Inventions By
Public Health Service Employees, Grantees, Fellowship Recipients, and
Contractors, 09-90-0067.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
The address of each agency component responsible for the system of
records is as shown in the System Manager(s) section.
SYSTEM MANAGER(S):
The System Managers are as follows:
For NIH invention records, joint invention records, and
records related to inventions that arose prior to FY 2017: National
Institutes of Health, Director, Office of Technology Transfer, Office
of Intramural Research, Office of the Director, 6011 Executive Blvd.,
Suite 325, Rockville, MD 20892-7660, [email protected], (301) 496-
7057.
For FDA invention records related to inventions that arose
in FY 2017 or later: Food and Drug Administration, Director, FDA
Technology Transfer Program, Office of the Chief Scientist, 10903 New
Hampshire Ave., Silver Spring, MD 20993, [email protected].
For CDC invention records related to inventions that arose
in FY 2017 or later: Centers for Disease Control and Prevention,
Associate Director for Science, Office of Technology and Innovation,
1600 Clifton Rd. NE, M/S D-42, Atlanta GA 30329-4018, [email protected],
(404) 639-1330.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
15 U.S.C. secs. 3701-3710d, National Technology Transfer and
Advancement Act; 35 U.S.C. secs. 200-212, Patent Rights in Inventions
Made with Federal Funding Assistance; 42 U.S.C. secs. 241, 282 and 284,
the Public Health Service Act; Executive Order (E.O.) 9865, Providing
for the Protection Abroad of Inventions Resulting from Research
Financed by the Government; and E.O. 10096, Providing for a Uniform
Patent Policy for the Government with Respect to Inventions made by
Government Employees and for the Administration of Such Policy. See
also 37 CFR parts 401 and 404, and 45 CFR part 7.
PURPOSE(S) OF THE SYSTEM:
The records are maintained and used by HHS for these purposes:
1. To obtain patent protection for inventions reported by Public
Health Service (PHS) employees, inventors, contractors, and non-profit
and educational institutions to which title is owned or co-owned by the
Federal Government.
2. To grant licenses to patents obtained through the invention
reports.
3. To provide royalty payments to the relevant PHS employees,
inventors, contractors, and non-profit and educational institutions.
4. To manage all assets of the technology transfer process (i.e.,
marketing, statistics, technology abstracts).
5. To refer to for information needed during award processing,
querying, and reporting.
6. To share relevant information with other HHS offices that manage
grants, contracts, or personnel associated with the invention,
including any information needed to investigate matters such as
possible law, contract, or grant agreement violations and issues
concerning an individual's or entity's suitability or eligibility for
federal employment, contracts, grants, licenses, or other federal
benefits. Records used by other HHS offices for such purposes, if
retrieved by personal identifier, would be covered under other Systems
of Records Notices (SORNs); see, for example, OPM/GOVT-3 covering
Adverse Action Files, 09-90-0020 covering Suitability for Employment
Records, and 09-90-0100 covering Civil and Administrative Investigative
Files of the Inspector General.
7. To provide documentation needed for related financial management
and debt collection functions, including effecting disbursements of
royalty awards and payments by the Department of the Treasury
(Treasury), coordinating with Treasury to recover any improper payments
or other claims through offsets against federal salary and tax refund
payments, and reporting royalty payments and uncollectible debt amounts
to the Internal Revenue Service (IRS) as income. Records used for
financial management and debt collection purposes are covered under
other HHS System of Records Notices (SORNs); see, e.g., HHS SORN Nos.
09-90-0024 HHS Financial Management System Records and 09-40-0012 Debt
Management and Collection System for descriptions of purposes for which
such records are used within HHS and routine uses for which such
records may be disclosed to the Department of Treasury and other
parties outside HHS.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The records are about inventors; i.e., any individual involved in
the development of an NIH, FDA, or CDC technology who reported an
invention, applied for a patent, was granted a patent, and/or is
receiving royalties from a patent to which title is owned or co-owned
by the Federal Government or by a grantee, fellowship recipient, or
contractor of the Federal Government. The inventor may be a PHS (or
other
[[Page 2750]]
HHS) employee, extramural grantee, fellowship recipient, independent
contractor, or other outside inventor or co-inventor.
CATEGORIES OF RECORDS IN THE SYSTEM:
The records consist of invention reports, patent prosecution and
licensing documents (such as patent applications and license
agreements) and related documents, containing all information necessary
to be included in such documents, for all individuals who contributed
to the invention. Applicable data elements may include: Inventor name,
job title, employing office or organization name and address, contact
information (mailing and email addresses, phone numbers, and fax
numbers), HHS employee identification number or other unique
identifier, inventor's status as a fellow or contract employee,
educational degree(s), citizenship, title and description of the
invention, Employee Invention Report (EIR) number, license number (if
an agreement provides for royalties to be paid by a third party),
number assigned to submitted invention report, case/serial number,
prior art related to the invention, evaluation of the commercial
potential of the invention, prospective licensees' intended development
of the invention, and royalty payment information.
RECORD SOURCE CATEGORIES:
Sources of information about inventors contained in these records
include the subject individual (i.e., inventor); other inventors, co-
inventors, and 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; PHS technology development
coordinators; internet and commercial databases; and third parties who
PHS contacts to determine individual invention ownership or government
ownership.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
In addition to other disclosures authorized directly in the Privacy
Act at 5 U.S.C. 552a(b)(4) through (11), information about an inventor
may be disclosed from this system of records to following parties
outside of HHS without the individual's prior written consent, for
these purposes:
1. HHS may make the inventor's name and other information public,
when making information about the invention public. For example, HHS
makes the inventor's name public in the Federal Register and/or on the
internet when it lists inventions that are available for collaboration
and/or licensing (i.e., to seek parties interested in licensing the
invention or in undertaking collaborative research activities to
further develop, evaluate, or commercialize the invention), and when
publicizing results of agency research activities. Information made
public without the inventor's prior, written consent would be limited
to information that HHS would be required to release to a requester
under the Freedom of Information Act (FOIA); meaning, information that
would not result in a clearly unwarranted invasion of privacy.
2. Disclosure may be made to a congressional office from the record
of an individual in response to a written inquiry from the
congressional office made at the written request of the individual.
3. A record may be disclosed to the Department of Justice (DOJ) or
to a court or other tribunal in litigation or other proceedings when:
(a) HHS, or any component thereof; (b) any HHS employee in his/her
official capacity; (c) any HHS employee in his/her individual capacity
where the DOJ (or HHS, where it is authorized to do so) has agreed to
represent the employee; or (d) the United States Government, is a party
to the proceeding or has a direct and substantial interest in the
proceeding and, by careful review, HHS determines that the records are
both relevant and necessary to the proceeding.
4. Records may be disclosed to authorized federal agencies,
programs, or other entities for purposes of program evaluation and
assessment, including quality assurance or peer review, audit, or
accreditation activities.
5. Information may be disclosed to federal agencies and HHS
contractors, grantees, consultants, or volunteers who have been engaged
by HHS to assist in accomplishment of an HHS function relating to the
purposes of this system of records and need to have access to the
records in order to assist HHS. Any contractor will be required to
comply with the requirements of the Privacy Act of 1974, as amended.
6. Information about an inventor may be included in information
disclosed to an awardee or contractor entity in connection with the
performance, administration, or evaluation of its contract under the
conditions of the particular award or contract.
7. Information about an inventor may be included in contractor past
performance information disclosed to a federal agency upon request.
8. As prescribed in HHS regulations, HHS may disclose system
information to qualified experts not within the definition of HHS
employees in order to obtain their advice about patent, licensing, and
other issues involved in the transfer, among agencies, of scientific
and technical discoveries.
9. HHS may disclose information from this system of records for the
purpose of obtaining patent protection for HHS inventions and licenses
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 HHS 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 Federal Government's ownership; and,
f. The United States and foreign patent offices involved in the
filing of HHS patent applications.
10. Disclosure may be made to: (a) Potential clinical trial
participants, consistent with the rules and regulations governing the
HHS human subjects protections program, when informing the participants
of an investigator's financial interests that might be relevant for
their consideration when deciding whether or not to participate in a
trial (i.e., if the financial interests include interests in an
invention); and (b) the general public to reveal summary-level
compensation that government scientists receive, under 15 U.S.C. 3710c,
on licensed inventions generated during their government work.
11. HHS may disclose information to the National Archives and
Records Administration (NARA), General Services Administration (GSA),
or other relevant federal agencies pursuant to records management
inspections conducted under the authority of 44 U.S.C. 2904 and 2906.
12. A record may be disclosed to appropriate agencies, entities,
and
[[Page 2751]]
persons when (1) HHS suspects or has confirmed that there has been a
breach of the system of records; (2) HHS has determined that as a
result of the suspected or confirmed breach there is a risk of harm to
individuals, HHS (including its information systems, programs, and
operations), the Federal Government, or national security; and (3) the
disclosure made to such agencies, entities, and persons is reasonably
necessary to assist in connection with HHS's efforts to respond to the
suspected or confirmed breach or to prevent, minimize, or remedy such
harm.
13. A record may be disclosed to another federal agency or federal
entity, when HHS determines that information from this system of
records is reasonably necessary to assist the recipient agency or
entity in (1) responding to a suspected or confirmed breach or (2)
preventing, minimizing, or remedying the risk of harm to individuals,
the recipient agency or entity (including its information systems,
programs, and operations), the Federal Government, or national
security, resulting from a suspected or confirmed breach.
14. Records may be disclosed to the Department of Homeland Security
(DHS) if captured in an intrusion detection system used by HHS and DHS
pursuant to a DHS cybersecurity program that monitors internet traffic
to and from federal government computer networks to prevent a variety
of types of cybersecurity incidents.
POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
Records are stored in electronic media (including, with prior
approval, on approved portable/mobile devices such as laptops, tablets,
PDAs, USB drives, media cards, portable hard drives, Blackberrys,
Smartphones, CDs, DVDs, and/or other mobile storage devices) and in
paper form.
POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
Records are retrieved by inventor name or identifying number (for
example, the NIH Enterprise Directory or NED ID number).
POLICIES AND PROCEDURES FOR RETENTION AND DISPOSAL OF RECORDS:
Currently, all records are retained and disposed of in accordance
with NIH records disposition schedule N1-443-10-1 and NIH Manual
Chapter 1743, Keeping and Destroying Records, Appendix 1, item 1100-L,
which provides for records to be kept for a maximum of thirty years. In
the event that separate disposition schedules are required for records
managed by FDA and CDC in FY 2017 or later, HHS will submit disposition
schedules for approval by the National Archives and Records
Administration (NARA) to cover those records.
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
Measures to prevent unauthorized disclosures are implemented as
appropriate for each location or form of storage and for the types of
records maintained. Safeguards conform to the HHS Information Security
and Privacy Program, https://www.hhs.gov/ocio/securityprivacy/. Site(s)
implement personnel and procedural safeguards such as the following:
Authorized Users: Access is strictly limited to authorized
personnel whose official duties require such access (i.e., valid,
business need to know).
Administrative Safeguards: Controls to ensure proper
protection of information and information technology systems include,
but are not limited to, the completion of a Security Assessment and
Authorization (SA&A) package and a Privacy Impact Assessment (PIA) and
mandatory completion of annual Information Security and Privacy
Awareness training. The SA&A package consists of a Security
Categorization, e-Authentication Risk Assessment, System Security Plan,
evidence of Security Control Testing, Plan of Action and Milestones (if
applicable), Contingency Plan, and evidence of Contingency Plan
Testing. When the design, development, or operation of a system of
records is performed by a contractor to accomplish an agency function,
the applicable Privacy Act Federal Acquisition Regulation (FAR) clauses
are inserted in solicitations and contracts.
Technical Safeguards: Controls that are generally executed
by the computer system and are employed to minimize the possibility of
unauthorized access, use, or dissemination of the data in the system
include, but are not limited to, user identification, password
protection, firewalls, virtual private network, encryption, intrusion
detection system, common access cards, smart cards, biometrics and
public key infrastructure.
Physical Safeguards: Controls to secure the data and
protect paper and electronic records, buildings, and related
infrastructure against threats associated with their physical
environment include, but are not limited to, the use of the HHS
Employee ID and/or badge number and key cards, security guards, cipher
locks, biometrics and closed-circuit TV. Paper records are secured in
locked file cabinets, offices and facilities. Electronic media are kept
on secure servers or computer systems. Records are stored in a
dedicated file room or in locking file cabinets in file folders. During
normal business hours, assigned agency personnel, including Records
Management staff and on-site contractor personnel, regulate
availability of the files. During evening and weekend hours the offices
are locked.
RECORD ACCESS PROCEDURES:
An individual who wishes to access a record about him or her in
this system of records must submit a written request to the relevant
System Manager, reasonably specify the record sought, and include (a)
the inventor's full name and address, (b) the approximate date(s) the
information was submitted, (c) the type(s) of information collected,
and (d) the office(s) or official(s) responsible for the collection of
information. In addition, the requester must verify his or her 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 of a record pertaining
to an individual under false pretenses is a criminal offense under the
Privacy Act, subject to a fine of up to five thousand dollars.
Individuals may also request an accounting of disclosures that have
been made of any records about them.
CONTESTING RECORD PROCEDURES:
Records that contain factually incorrect information may be
contested. To contest information in a record about you, write to the
relevant System Manager; provide the same information described under
``Record Access Procedures,'' including identity verification
information; and specify the information which is contested, the
corrective action sought, and the reason(s) for requesting the
correction, along with supporting information. The right to contest
records is limited to information which is factually inaccurate,
incomplete, irrelevant, or untimely (obsolete).
NOTIFICATION PROCEDURES:
An individual who wishes to know if this system of records contains
a record about him or her must write to the relevant System Manager and
provide the same information described under ``Record Access
Procedures,'' including identity verification information.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
[[Page 2752]]
HISTORY:
47 FR 45514 (Oct. 13, 1982), 59 FR 55845 (Nov. 9, 1994), 83 FR 6591
(Feb. 14, 2018).
NOTICE OF RESCINDMENT:
The following system of records is rescinded as duplicative of
system 09-90-0067:
SYSTEM NAME AND NUMBER:
Invention, Patent, and Licensing Documents Submitted to the Public
Health Service by its Employees, Grantees, Fellowship Recipients, and
Contractors, 09-25-0168.
HISTORY:
71 FR 46496 (Aug. 14, 2006), 83 FR 6591 (Feb. 14, 2018).
[FR Doc. 2020-00633 Filed 1-15-20; 8:45 am]
BILLING CODE 4140-01-P