Privacy Act of 1974; System of Records Notice, 83246-83250 [2016-27959]
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Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Notices
information collection provisions in the
guidance.
Description of Respondents: The
likely respondents include businesses
engaged in the manufacture or sale of
food, food ingredients, and substances
used in materials that come into contact
with food.
In the Federal Register of August 25,
2016 (81 FR 58517), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
25.15
25.15
25.15
25.40
(a)
(a)
(a)
(a)
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
& (d) (to cover CEs under 25.32(i)) .....................
&(d) (to cover CEs under 25.32(o)) .....................
&(d) (to cover CEs under 25.32(q)) .....................
& (c) EAs ..............................................................
47
1
3
57
1
1
1
1
47
1
3
57
8
8
8
180
376
8
24
10,260
Total ..............................................................................
........................
........................
........................
........................
10,668
asabaliauskas on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates for respondents and
numbers of responses are based on the
annualized numbers of petitions and
notifications qualifying for categorical
exclusions listed under § 25.32(i) and
(q) that the Agency has received in the
past 3 years. Please note that, in the past
3 years, there have been no submissions
that requested an action that would
have been subject to the categorical
exclusion in § 25.32(o). To avoid
counting this burden as zero, we have
estimated the burden for this categorical
exclusion at one respondent making one
submission a year for a total of one
annual submission. The burden for
submitting a categorical exclusion is
captured under § 25.15(a) and (d).
To calculate the estimate for the hours
per response values, we assumed that
the information requested in this
guidance for each of these three
categorical exclusions is readily
available to the submitter. For the
information requested for the exclusion
in § 25.32(i), we expect that submitter
will need to gather information from
appropriate persons in the submitter’s
company and prepare this information
for attachment to the claim for
categorical exclusion. We believe that
this effort should take no longer than 8
hours per submission. For the
information requested for the categorical
exclusions in § 25.32(o) and (q), the
submitters will almost always merely
need to copy existing documentation
and attach it to the claim for categorical
exclusion. We believe that collecting
this information should also take no
longer than 8 hours per submission.
For the information requested for the
environmental assessments in § 25.40(a)
and (c), we believe that submitters will
submit an average of 57 environmental
assessments annually. We estimate that
each submitter will prepare an EA
within 3 weeks (120 hours) and revise
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the EA based on Agency comments
(between 40 to 60 hours), for a total
preparation time of 180 hours. The
burden relating to this collection has
been previously approved under OMB
control number 0910–0322,
‘‘Environmental Impact Consideration—
21 CFR part 25’’. Upon approval of this
collection of information by OMB, FDA
will revise OMB control number 0910–
0322 to remove the annual reporting
burden for categorical exclusions and
environmental assessment requests
related to food additive petitions, color
additive petitions, requests for
exemption from regulation as a food
additive, and submission of a food
contact notification for a food contact
substance. The future burden for
categorical exclusion or environmental
assessments for these requests will be
captured under OMB control number
0910–0541, this collection of
information.
Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–27943 Filed 11–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Privacy Act of 1974; System of
Records Notice
Department of Health and
Human Services (HHS), Office of the
Secretary (OS)
ACTION: Notice to establish a new system
of records, and to delete related systems.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
as amended, HHS is establishing a new,
SUMMARY:
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Fmt 4703
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department-wide system of records,
System No. 09–90–1601 ‘‘Outside
Experts Recruited for Non-FACA
Activities,’’ and deleting four related
systems of records that are obsolete or
that will be rendered duplicative by the
new system. The new system will cover
recruitment and other administrative
records about individuals outside the
HHS workforce who serve or are
considered for service on HHS missionrelated committees and other
assignments requiring specific outside
expertise or experience (excluding those
that are subject to the Federal Advisory
Committee Act (FACA), which are
covered under System No. 09–90–0059).
The new department-wide System No.
09–90–1601 and the related system
deletions are more fully explained in
the SUPPLEMENTARY INFORMATION section
of this Notice.
DATES: The new system of records
established in this Notice is effective
upon publication, with the exception of
the routine uses. The routine uses will
be effective 30 days after publication of
this Notice, unless comments are
received that warrant a revision to this
Notice. Written comments on the Notice
should be submitted within 30 days.
The deletion of System Numbers 09–20–
0168, 09–30–0049, 09–37–0022, and 09–
90–0080 will be effective 30 days after
publication of this Notice.
ADDRESSES: The public should address
written comments to: Beth Kramer, HHS
Privacy Act Officer, FOIA/PA Division,
Hubert H. Humphrey Building—Suite
729H, 200 Independence Avenue SW.,
Washington, DC 20201, beth.kramer@
hhs.gov.
FOR FURTHER INFORMATION CONTACT: Beth
Kramer, HHS Privacy Act Officer, FOIA/
PA Division, Hubert H. Humphrey
Building—Suite 729H, 200
Independence Avenue SW.,
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Washington, DC 20201, beth.kramer@
hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Explanation of New System No. 09–
90–1601
The records to be covered in the new
system of records are similar in type and
function to the records covered in
System No. 09–90–0059, which pertain
to individuals who serve or are
considered for service on committees
that are subject to the Federal Advisory
Committee Act (FACA), 5 U.S.C. App.,
et seq.; the key difference is that they
will be about outside individuals
serving or considered for service on
mission-related committees and other
activities that are not subject to FACA.
Following are the non-FACA-related
programs at HHS that recruit and utilize
individuals with outside expertise or
experience and maintain records about
the outside individuals in systems that
retrieve the records by personal
identifier:
• Curricula Vitae of Consultants to
the National Center for Health Statistics
(NCHS) within the Centers for Disease
Control and Prevention (CDC) (formerly
covered under SORN 09–20–0168). This
program maintains records about
individuals with special expertise,
training, and professional experience
who may be enlisted to assist CDC/
NCHS as consultants. The records are
used by CDC/NCHS to select
individuals to participate in
assignments such as: planning and
conducting surveys, studies, statistical
reporting programs, and statistical
analyses of data; providing training and
technical assistance; and planning and
conducting conferences. These records
currently are covered under SORN No.
09–20–0168, which is being deleted and
subsumed under the new departmentwide SORN No. 09–90–1601.
• The Food and Drug Administration
(FDA) Patient Representative Program.
This program enlists individuals with
patient advocacy experience to serve as
patient representatives on both FACA
committees and non-FACA assignments.
For example, patient representatives
may provide input that is used in
making decisions to approve devices or
drugs, or may contribute to discussions
at presentations and conferences.
Records about patient representatives
are retrieved by the representatives’
names, and will be covered under either
SORN No. 09–90–0059 or the new
department-wide SORN No. 09–90–
1601, depending on whether the records
pertain to service on a FACA committee
or service on a non-FACA assignment.
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• Peer Review Programs at the
Administration for Children and
Families (ACF), Health Resources and
Services Administration (HRSA), and
Substance Abuse and Mental Health
Services Administration (SAMHSA) that
recruit and use outside individuals to
serve on peer review committees formed
to review applications for grants and
cooperative agreements. These programs
exist in several HHS components, but
only ACF, HRSA, and SAMHSA
sometimes use a personal identifier (i.e.,
name) to retrieve administrative records
about the outside individuals they
recruit and use. Other components
(including the Office of the Assistant
Secretary for Health (OASH), Centers for
Medicare & Medicaid Services (CMS),
and National Institutes of Health (NIH))
use only non-personal identifiers (e.g.,
expertise type, or funding opportunity
announcement number) for retrieval.
• Consultants on Other SAMHSA
Projects (formerly covered under SORN
09–30–0049). SAMHSA contractors
arrange for outside consultants to be
used in other SAMHSA programs
(besides peer review programs) when
technical assistance is needed in
conferences, meetings, and evaluation
projects that involve a specialized area
of research, review, or advice.
A report on the new system of records
has been sent to Congress and OMB in
accordance with 5 U.S.C. 552a(r).
II. Deletion of Four Related Systems of
Records
The following systems of records are
being deleted as duplicative of new
department-wide System No. 09–90–
1601:
• 09–20–0168 Curricula Vitae of
Consultants to the National Center for
Health Statistics
• 09–30–0049 Consultant Records
Maintained by SAMHSA Contractors
The following system of records is
being deleted as duplicative of System
No. 09–90–0059 Federal Advisory
Committee Membership Files as to files
that pertain to candidates for FACA
committees, and as duplicative of new
department-wide System No. 09–90–
1601 as to files that pertain to
candidates for non-FACA committees
and other activities:
• 09–90–0080 The Secretary’s Advisory
Committee Candidate Files
The following system of records is being
deleted because it is obsolete and the
records no longer exist:
• 9–37–0022 Records of Health Experts
Maintained by the Office of
International Health
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III. The Privacy Act
The Privacy Act (5 U.S.C. 552a)
governs the means by which the U.S.
Government collects, maintains, and
uses information about individuals in a
system of records. A ‘‘system of
records’’ is a group of any records under
the control of a federal agency from
which information about an individual
is retrieved by the individual’s name or
other personal identifier. The Privacy
Act requires each agency to publish in
the Federal Register a system of records
notice (SORN) identifying and
describing each system of records the
agency maintains, including the
purposes for which the agency uses
information about individuals in the
system, the routine uses for which the
agency discloses such information
outside the agency, and how individual
record subjects can exercise their rights
under the Privacy Act.
Dated: November 1, 2016.
Beth Kramer,
Privacy Act Officer, FOIA/Privacy Act
Division, Assistant Secretary for Public
Affairs, Department of Health and Human
Services.
Notice of Deletion of Related Systems
The following systems of record are
deleted, effective 30 days after
publication of this Notice:
1. 09–20–0168 Curricula Vitae of
Consultants to the National Center
for Health Statistics
2. 09–30–0049 Consultant Records
Maintained by SAMHSA
Contractors
3. 09–90–0080 The Secretary’s Advisory
Committee Candidate Files
4. 09–37–0022 Records of Health
Experts Maintained by the Office of
International Health
SYSTEM NUMBER:
09–90–1601
SYSTEM NAME:
Outside Experts Recruited for NonFACA Activities
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
Physical locations include:
• CDC program offices that recruit
consultants to assist in statistical
projects and reporting programs
conducted or sponsored by NCHS, in
Atlanta, GA and Hyattsville, MD;
• FDA’s committee management
office in Silver Spring, MD;
• Program offices at ACF in
Washington, DC, at HRSA in Rockville,
MD, and at SAMHSA in Rockville, MD,
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that recruit individuals to serve as peer
reviewers; and
• Locations of SAMHSA contractors
that arrange use of consultants on
SAMHSA projects.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
Records in this system pertain to
individuals outside the HHS workforce
who serve or are considered for service
on HHS mission-related committees or
other assignments that require specific
outside expertise or experience (for
example, medical, scientific, or
manufacturing expertise, or patient
advocacy experience), but that are not
subject to the Federal Advisory
Committee Act (FACA), 5 U.S.C. App.,
et seq.
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CATEGORIES OF RECORDS IN THE SYSTEM:
The records consist of recruitment
and other administrative records,
including:
• An application and resume or
curricula vitae, describing the
individual’s qualifications;
• Nomination/recommendation
records, or other records used in
evaluating an individual’s qualifications
and any potential conflicts of interest
and selecting an individual for a
specific assignment; and
• Records used to plan and arrange
the individual’s participation in the
assigned activities, including
scheduling records and records used to
coordinate parking, badging, and
payment of any stipend or honorarium.
The records may contain these data
elements:
• The individual’s name and other
identifying information (e.g., sex, place
and date of birth);
• Contact information (e.g., home and
business addresses, telephone numbers,
email addresses);
• Occupation, job titles, employers,
employment status and history, and
whether currently employed by the
federal government;
• Work and organizational
affiliations, memberships, credentials,
and licenses;
• Degrees held, and general
educational and/or experience
background;
• Racial classification or ethnic
background;
• Areas of specialization, expertise, or
experience, and special qualifications
(e.g., language or technical skills, ability
to drive to an assignment);
• Dates and descriptions of past
assignments or past experience;
• Sources and references, and any
information provided by sources/
references; and
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• Information about availability and
any special needs.
Any special needs, medical condition,
or similar information contained in an
individual’s records is maintained and
used in accordance with relevant
provisions of the Rehabilitation Act of
1973, as amended, 29 U.S.C. 791 et seq.,
and implementing regulations at 29 CFR
parts 1614 and 1630, and the Genetic
Information Nondiscrimination Act of
2008 at 42 U.S.C. 2000ff et seq.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
For CDC/NCHS Consultant Records:
42 U.S.C. 242b(b)(3).
For FDA Patient Representative
Records: 21 U.S.C. 360bbb–8c, 371 et
seq., 379d–1(b)(1)(A).
For ACF Peer Reviewer Records: 42
U.S.C. 799(f), 806(e).
For HRSA Peer Reviewer Records: 42
U.S.C. 799(f), 806(e).
For SAMHSA Peer Reviewer and
Other Consultant Records: 42 U.S.C.
241, 249(c), 290aa et seq., 290aa–5,
290bb et seq., 290bb–21 et seq., 290bb–
31 et seq., 5121 et seq., 10801 et seq.;
8 U.S.C. 1522 note; Executive Order
12341.
See also: 5 U.S.C. 3109.
PURPOSE(S):
The records will be used within the
agency on a need-to-know basis for the
purpose of staffing committees and
other assignments and managing
administrative matters pertaining to
individuals serving on committees and
other assignments, including to:
• Prepare reports and lists of past,
present, and recommended members,
vacancies, acceptances, and separations;
• Send recruitment notices to
individual prospective candidates, and
send informational notices to selectees;
• Identify qualified candidates and
document the selections; and
• Manage and coordinate the selected
individuals’ participation in assignment
activities (including sharing information
within the agency to coordinate aspects
such as badging, parking, travel,
training, and payment of any stipend or
honorarium).
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
THE PURPOSES OF SUCH USES:
In addition to the statutory
disclosures of information permitted in
the Privacy Act at 5 U.S.C. 552a(b)(2)
and (b)(4)–(11), HHS may make the
following disclosures of information
about an individual from this system of
records to parties outside the agency
without the individual’s prior, written
consent:
1. Disclosures may be made to federal
agencies and Department contractors
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that have been engaged by HHS to assist
in accomplishment of an HHS function
relating to the purposes of this system
of records and that have a need to have
access to the records in order to assist
HHS in performing the activity. Any
contractor will be required to comply
with the requirements of the Privacy
Act.
2. Records may be disclosed to parties
such as educational institutions, current
and former employers, and qualified
experts, when necessary to check or
obtain an opinion about a candidate’s
qualifications.
3. Records about consultants and
patient advocates may be disclosed to
parties organizing or hosting assignment
activities, such as grantee institutions
and federal, foreign, state, tribal, local,
and other government agencies and
public authorities (e.g., U.S. Embassies
and Ministries of Health), when
necessary to apprise them of an
individual’s qualifications for the
assignment or coordinate the
individual’s participation in the
activities.
4. Records may be disclosed to
supervisors and administrative
assistants at the individual’s place of
employment, for administrative
purposes such as coordinating the
individual’s participation in the
activities.
5. Records may be disclosed to
external parties that audit committee or
assignment activities.
6. Relevant information will be
included in any required reports to the
President, the Office of Management
and Budget (OMB), and the General
Services Administration (GSA) about
committees and other assignments that
are mission-related.
7. Information may be disclosed to the
U.S. Department of Justice (DOJ) or to a
court or other tribunal, when:
a. The agency or any component
thereof, or
b. Any employee of the agency in his
or her official capacity, or
c. Any employee of the agency in his
or her individual capacity where DOJ
has agreed to represent the employee, or
d. The United States Government,
is a party to litigation or has an interest
in such litigation and, by careful review,
HHS determines that the records are
both relevant and necessary to the
litigation and that, therefore, the use of
such records by the DOJ, court or other
tribunal is deemed by HHS to be
compatible with the purpose for which
the agency collected the records.
8. Records may be disclosed to
student volunteers and other
individuals performing functions for the
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Department but technically not having
the status of agency employees, if they
need access to the records in order to
perform their assigned agency functions.
9. Disclosures may be made to the
National Archives and Records
Administration (NARA) and/or the
General Services Administration (GSA)
for the purpose of records management
inspections conducted under 44 U.S.C.
2904 and 2906.
10. Information may be disclosed to a
Member of Congress or a Congressional
staff member in response to a written
inquiry of the Congressional office made
at the written request of the constituent
about whom the record is maintained.
The Congressional office does not have
any greater authority to obtain records
than the individual would have if
requesting the records directly.
11. Records may be disclosed to the
U.S. 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.
12. Disclosures may be made to
appropriate federal agencies and
Department contractors that have a need
to know the information for the purpose
of assisting the Department’s efforts to
respond to a suspected or confirmed
breach of the security or confidentiality
of information maintained in this
system of records, when the information
disclosed is relevant and necessary to
that assistance.
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM—
STORAGE:
Records are stored in hard-copy files
and electronic media.
RETRIEVABILITY:
Records are retrieved by the
individual’s name.
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SAFEGUARDS:
Safeguards conform to the HHS
Information Security and Privacy
Program, https://www.hhs.gov/ocio/
securityprivacy/. Information
is safeguarded in accordance with
applicable laws, rules and policies,
including the HHS Information
Technology Security Program
Handbook, all pertinent National
Institutes of Standards and Technology
(NIST) publications, and OMB Circular
A–130, Management of Federal
Resources. Records are protected from
unauthorized access through
appropriate administrative, physical,
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and technical safeguards. These
safeguards include protecting the
facilities where records are stored or
accessed with security guards, badges
and cameras, securing hard-copy
records in locked file cabinets, file
rooms or offices during off-duty hours,
limiting access to electronic databases to
authorized users based on roles and
two-factor authentication (user ID and
password), using a secured operating
system protected by encryption,
firewalls, and intrusion detection
systems, requiring encryption for
records stored on removable media, and
training personnel in Privacy Act and
information security requirements.
Records that are eligible for destruction
are disposed of using destruction
methods prescribed by NIST SP 800–88.
RETENTION AND DISPOSAL:
Records pertaining to recruitment and
use of outside peer reviewers are
destroyed three years after final action;
they are retained longer if required for
business use (see General Records
Schedule (GRS) 1.2, Item 010, Grant and
Cooperative Agreement Program
Management Records). Records
pertaining to recruitment and use of
other outside individuals (e.g., experts,
patient advocates, and members of
mission-related non-FACA committees)
are currently unscheduled.
Unscheduled records must be retained
indefinitely pending the agency’s
submission, and NARA’s approval, of a
disposition schedule. HHS anticipates
proposing to NARA, as an appropriate
retention period for these records,
‘‘three years after final action, or longer
if required for business use’’ (similar to
the period provided in GRS 1.2, Item
010) or ‘‘when no longer needed for
administrative purposes’’ (similar to the
periods applicable to similar records not
retrieved by personal identifier which
are not covered under this SORN; i.e.:
N1–442–93–1, Item 37 for the Agency
for Toxic Substances and Disease
Registry’s Curriculum Vitae Files, and
NC1–235–82–1, Item 100–3 for the
Office of the Secretary’s Advisory
Committee Candidate Resume Files).
SYSTEM MANAGER(S) AND ADDRESS(ES):
For CDC/NCHS Consultant Records:
• Centers for Disease Control and
Prevention (CDC), Director, National
Center for Health Statistics, OPHSS,
Prince George’s Metro IV Bldg., Rm.
7209, MS P08, Centers for Disease
Control and Prevention, 3311 Toledo
Road, Hyattsville, MD 20782
For FDA Patient Representative
Records:
• Food and Drug Administration
(FDA), Advisory Committee Oversight &
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83249
Management Staff, 10903 New
Hampshire Avenue, Bldg. WO32, Rm.
5129, Silver Spring, MD 20993–002
For ACF Peer Reviewer Records:
• Administration for Children and
Families (ACF), Privacy Act Contact,
Office of Information Systems 330 C
Street, NW., Washington, DC 20201
For HRSA Peer Reviewer Records:
• Health Resources and Services
Administration (HRSA), Chief, Policy,
Analysis & Training Branch, Division of
Independent Review, Office of Federal
Assistance Management, 5600 Fishers
Lane, Rockville, MD 20857
For SAMHSA Peer Reviewer Records:
• Substance Abuse and Mental Health
Services Administration (SAMHSA),
Director, Division of Grant Review, 5600
Fishers lane, Rockville, MD 20852
For Other Consultant Records,
Maintained by SAMHSA Contractors:
• Substance Abuse and Mental Health
Services Administration (SAMHSA),
Director, Division of Contracts
Management, Office of Program
Services, 5600 Fishers Lane, Rockville,
MD 20852
NOTIFICATION PROCEDURE:
An individual who wishes to know if
this system contains records about him
or her should submit a written request
to the relevant System Manager
indicated above. The individual 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 for acquisition of a
record pertaining to an individual under
false pretenses is a criminal offense
under the Privacy Act, subject to a five
thousand dollar fine.
RECORD ACCESS PROCEDURE:
An individual seeking access to
records about him in this system should
submit a request following the same
procedure indicated under ‘‘Notification
Procedure.’’
CONTESTING RECORD PROCEDURE:
An individual seeking to amend the
content of information about him or her
in this system should contact the
relevant System Manager indicated
above and reasonably identify the
record, specify the information
contested, state the corrective action
sought, and provide the reasons for the
amendment, with supporting
justification.
RECORD SOURCE CATEGORIES:
Most information is obtained directly
from the individual record subject.
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Information pertaining to references and
recommendations is obtained from other
private individuals, educational
institutions, current and former
employers, HHS program personnel,
biographical reference books, private
organizations, Members of Congress,
and other government sources.
EXEMPTIONS CLAIMED FOR THE SYSTEM:
None.
[FR Doc. 2016–27959 Filed 11–18–16; 8:45 am]
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: November 15, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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.
[FR Doc. 2016–27876 Filed 11–18–16; 8:45 am]
BILLING CODE P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Human Virome in Heart, Lung, and Blood
Health and Resilience.
Date: December 9, 2016.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Kristen Page, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7185, Bethesda, MD 20892, 301–496–2434,
kristen.page@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
T32—Training Programs for Institutions that
Promote Diversity.
Date: December 9, 2016.
Time: 11:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7189, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Stephanie L. Constant,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7189, Bethesda, MD 20892, 301–
443–8784, constantsl@nhlbi.nih.gov.
VerDate Sep<11>2014
18:09 Nov 18, 2016
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National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), 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
Drug Abuse Special Emphasis Panel, Multisite Clinical Trials SEP III.
Date: December 9, 2016.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Susan O. McGuire, Ph.D.,
Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, National Institutes of Health,
DHHS, 6001 Executive Blvd., Room 4245,
Rockville, MD 20852, (301) 827–5817,
mcguireso@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: November 15, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–27878 Filed 11–18–16; 8:45 am]
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National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Name of Committee: Heart, Lung, and
Blood Initial Review Group, NHLBI
Institutional Training Mechanism Review
Committee.
Date: December 9, 2016.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7194, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Charles Joyce, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7194, Bethesda, MD 20892–7924, 301–435–
0288, cjoyce@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: November 15, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–27875 Filed 11–18–16; 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
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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
E:\FR\FM\21NON1.SGM
21NON1
Agencies
[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Notices]
[Pages 83246-83250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27959]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Privacy Act of 1974; System of Records Notice
AGENCY: Department of Health and Human Services (HHS), Office of the
Secretary (OS)
ACTION: Notice to establish a new system of records, and to delete
related systems.
-----------------------------------------------------------------------
SUMMARY: In accordance with the requirements of the Privacy Act of
1974, as amended, HHS is establishing a new, department-wide system of
records, System No. 09-90-1601 ``Outside Experts Recruited for Non-FACA
Activities,'' and deleting four related systems of records that are
obsolete or that will be rendered duplicative by the new system. The
new system will cover recruitment and other administrative records
about individuals outside the HHS workforce who serve or are considered
for service on HHS mission-related committees and other assignments
requiring specific outside expertise or experience (excluding those
that are subject to the Federal Advisory Committee Act (FACA), which
are covered under System No. 09-90-0059). The new department-wide
System No. 09-90-1601 and the related system deletions are more fully
explained in the Supplementary Information section of this Notice.
DATES: The new system of records established in this Notice is
effective upon publication, with the exception of the routine uses. The
routine uses will be effective 30 days after publication of this
Notice, unless comments are received that warrant a revision to this
Notice. Written comments on the Notice should be submitted within 30
days. The deletion of System Numbers 09-20-0168, 09-30-0049, 09-37-
0022, and 09-90-0080 will be effective 30 days after publication of
this Notice.
ADDRESSES: The public should address written comments to: Beth Kramer,
HHS Privacy Act Officer, FOIA/PA Division, Hubert H. Humphrey
Building--Suite 729H, 200 Independence Avenue SW., Washington, DC
20201, beth.kramer@hhs.gov.
FOR FURTHER INFORMATION CONTACT: Beth Kramer, HHS Privacy Act Officer,
FOIA/PA Division, Hubert H. Humphrey Building--Suite 729H, 200
Independence Avenue SW.,
[[Page 83247]]
Washington, DC 20201, beth.kramer@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Explanation of New System No. 09-90-1601
The records to be covered in the new system of records are similar
in type and function to the records covered in System No. 09-90-0059,
which pertain to individuals who serve or are considered for service on
committees that are subject to the Federal Advisory Committee Act
(FACA), 5 U.S.C. App., et seq.; the key difference is that they will be
about outside individuals serving or considered for service on mission-
related committees and other activities that are not subject to FACA.
Following are the non-FACA-related programs at HHS that recruit and
utilize individuals with outside expertise or experience and maintain
records about the outside individuals in systems that retrieve the
records by personal identifier:
Curricula Vitae of Consultants to the National Center for
Health Statistics (NCHS) within the Centers for Disease Control and
Prevention (CDC) (formerly covered under SORN 09-20-0168). This program
maintains records about individuals with special expertise, training,
and professional experience who may be enlisted to assist CDC/NCHS as
consultants. The records are used by CDC/NCHS to select individuals to
participate in assignments such as: planning and conducting surveys,
studies, statistical reporting programs, and statistical analyses of
data; providing training and technical assistance; and planning and
conducting conferences. These records currently are covered under SORN
No. 09-20-0168, which is being deleted and subsumed under the new
department-wide SORN No. 09-90-1601.
The Food and Drug Administration (FDA) Patient
Representative Program. This program enlists individuals with patient
advocacy experience to serve as patient representatives on both FACA
committees and non-FACA assignments. For example, patient
representatives may provide input that is used in making decisions to
approve devices or drugs, or may contribute to discussions at
presentations and conferences. Records about patient representatives
are retrieved by the representatives' names, and will be covered under
either SORN No. 09-90-0059 or the new department-wide SORN No. 09-90-
1601, depending on whether the records pertain to service on a FACA
committee or service on a non-FACA assignment.
Peer Review Programs at the Administration for Children
and Families (ACF), Health Resources and Services Administration
(HRSA), and Substance Abuse and Mental Health Services Administration
(SAMHSA) that recruit and use outside individuals to serve on peer
review committees formed to review applications for grants and
cooperative agreements. These programs exist in several HHS components,
but only ACF, HRSA, and SAMHSA sometimes use a personal identifier
(i.e., name) to retrieve administrative records about the outside
individuals they recruit and use. Other components (including the
Office of the Assistant Secretary for Health (OASH), Centers for
Medicare & Medicaid Services (CMS), and National Institutes of Health
(NIH)) use only non-personal identifiers (e.g., expertise type, or
funding opportunity announcement number) for retrieval.
Consultants on Other SAMHSA Projects (formerly covered
under SORN 09-30-0049). SAMHSA contractors arrange for outside
consultants to be used in other SAMHSA programs (besides peer review
programs) when technical assistance is needed in conferences, meetings,
and evaluation projects that involve a specialized area of research,
review, or advice.
A report on the new system of records has been sent to Congress and
OMB in accordance with 5 U.S.C. 552a(r).
II. Deletion of Four Related Systems of Records
The following systems of records are being deleted as duplicative
of new department-wide System No. 09-90-1601:
09-20-0168 Curricula Vitae of Consultants to the National
Center for Health Statistics
09-30-0049 Consultant Records Maintained by SAMHSA Contractors
The following system of records is being deleted as duplicative of
System No. 09-90-0059 Federal Advisory Committee Membership Files as to
files that pertain to candidates for FACA committees, and as
duplicative of new department-wide System No. 09-90-1601 as to files
that pertain to candidates for non-FACA committees and other
activities:
09-90-0080 The Secretary's Advisory Committee Candidate Files
The following system of records is being deleted because it is obsolete
and the records no longer exist:
9-37-0022 Records of Health Experts Maintained by the Office
of International Health
III. The Privacy Act
The Privacy Act (5 U.S.C. 552a) governs the means by which the U.S.
Government collects, maintains, and uses information about individuals
in a system of records. A ``system of records'' is a group of any
records under the control of a federal agency from which information
about an individual is retrieved by the individual's name or other
personal identifier. The Privacy Act requires each agency to publish in
the Federal Register a system of records notice (SORN) identifying and
describing each system of records the agency maintains, including the
purposes for which the agency uses information about individuals in the
system, the routine uses for which the agency discloses such
information outside the agency, and how individual record subjects can
exercise their rights under the Privacy Act.
Dated: November 1, 2016.
Beth Kramer,
Privacy Act Officer, FOIA/Privacy Act Division, Assistant Secretary for
Public Affairs, Department of Health and Human Services.
Notice of Deletion of Related Systems
The following systems of record are deleted, effective 30 days
after publication of this Notice:
1. 09-20-0168 Curricula Vitae of Consultants to the National Center for
Health Statistics
2. 09-30-0049 Consultant Records Maintained by SAMHSA Contractors
3. 09-90-0080 The Secretary's Advisory Committee Candidate Files
4. 09-37-0022 Records of Health Experts Maintained by the Office of
International Health
SYSTEM NUMBER:
09-90-1601
SYSTEM NAME:
Outside Experts Recruited for Non-FACA Activities
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
Physical locations include:
CDC program offices that recruit consultants to assist in
statistical projects and reporting programs conducted or sponsored by
NCHS, in Atlanta, GA and Hyattsville, MD;
FDA's committee management office in Silver Spring, MD;
Program offices at ACF in Washington, DC, at HRSA in
Rockville, MD, and at SAMHSA in Rockville, MD,
[[Page 83248]]
that recruit individuals to serve as peer reviewers; and
Locations of SAMHSA contractors that arrange use of
consultants on SAMHSA projects.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
Records in this system pertain to individuals outside the HHS
workforce who serve or are considered for service on HHS mission-
related committees or other assignments that require specific outside
expertise or experience (for example, medical, scientific, or
manufacturing expertise, or patient advocacy experience), but that are
not subject to the Federal Advisory Committee Act (FACA), 5 U.S.C.
App., et seq.
CATEGORIES OF RECORDS IN THE SYSTEM:
The records consist of recruitment and other administrative
records, including:
An application and resume or curricula vitae, describing
the individual's qualifications;
Nomination/recommendation records, or other records used
in evaluating an individual's qualifications and any potential
conflicts of interest and selecting an individual for a specific
assignment; and
Records used to plan and arrange the individual's
participation in the assigned activities, including scheduling records
and records used to coordinate parking, badging, and payment of any
stipend or honorarium.
The records may contain these data elements:
The individual's name and other identifying information
(e.g., sex, place and date of birth);
Contact information (e.g., home and business addresses,
telephone numbers, email addresses);
Occupation, job titles, employers, employment status and
history, and whether currently employed by the federal government;
Work and organizational affiliations, memberships,
credentials, and licenses;
Degrees held, and general educational and/or experience
background;
Racial classification or ethnic background;
Areas of specialization, expertise, or experience, and
special qualifications (e.g., language or technical skills, ability to
drive to an assignment);
Dates and descriptions of past assignments or past
experience;
Sources and references, and any information provided by
sources/references; and
Information about availability and any special needs.
Any special needs, medical condition, or similar information
contained in an individual's records is maintained and used in
accordance with relevant provisions of the Rehabilitation Act of 1973,
as amended, 29 U.S.C. 791 et seq., and implementing regulations at 29
CFR parts 1614 and 1630, and the Genetic Information Nondiscrimination
Act of 2008 at 42 U.S.C. 2000ff et seq.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
For CDC/NCHS Consultant Records: 42 U.S.C. 242b(b)(3).
For FDA Patient Representative Records: 21 U.S.C. 360bbb-8c, 371 et
seq., 379d-1(b)(1)(A).
For ACF Peer Reviewer Records: 42 U.S.C. 799(f), 806(e).
For HRSA Peer Reviewer Records: 42 U.S.C. 799(f), 806(e).
For SAMHSA Peer Reviewer and Other Consultant Records: 42 U.S.C.
241, 249(c), 290aa et seq., 290aa-5, 290bb et seq., 290bb-21 et seq.,
290bb-31 et seq., 5121 et seq., 10801 et seq.; 8 U.S.C. 1522 note;
Executive Order 12341.
See also: 5 U.S.C. 3109.
PURPOSE(S):
The records will be used within the agency on a need-to-know basis
for the purpose of staffing committees and other assignments and
managing administrative matters pertaining to individuals serving on
committees and other assignments, including to:
Prepare reports and lists of past, present, and
recommended members, vacancies, acceptances, and separations;
Send recruitment notices to individual prospective
candidates, and send informational notices to selectees;
Identify qualified candidates and document the selections;
and
Manage and coordinate the selected individuals'
participation in assignment activities (including sharing information
within the agency to coordinate aspects such as badging, parking,
travel, training, and payment of any stipend or honorarium).
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
In addition to the statutory disclosures of information permitted
in the Privacy Act at 5 U.S.C. 552a(b)(2) and (b)(4)-(11), HHS may make
the following disclosures of information about an individual from this
system of records to parties outside the agency without the
individual's prior, written consent:
1. Disclosures may be made to federal agencies and Department
contractors that have been engaged by HHS to assist in accomplishment
of an HHS function relating to the purposes of this system of records
and that have a need to have access to the records in order to assist
HHS in performing the activity. Any contractor will be required to
comply with the requirements of the Privacy Act.
2. Records may be disclosed to parties such as educational
institutions, current and former employers, and qualified experts, when
necessary to check or obtain an opinion about a candidate's
qualifications.
3. Records about consultants and patient advocates may be disclosed
to parties organizing or hosting assignment activities, such as grantee
institutions and federal, foreign, state, tribal, local, and other
government agencies and public authorities (e.g., U.S. Embassies and
Ministries of Health), when necessary to apprise them of an
individual's qualifications for the assignment or coordinate the
individual's participation in the activities.
4. Records may be disclosed to supervisors and administrative
assistants at the individual's place of employment, for administrative
purposes such as coordinating the individual's participation in the
activities.
5. Records may be disclosed to external parties that audit
committee or assignment activities.
6. Relevant information will be included in any required reports to
the President, the Office of Management and Budget (OMB), and the
General Services Administration (GSA) about committees and other
assignments that are mission-related.
7. Information may be disclosed to the U.S. Department of Justice
(DOJ) or to a court or other tribunal, when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity
where DOJ has agreed to represent the employee, or
d. The United States Government, is a party to litigation or has an
interest in such litigation and, by careful review, HHS determines that
the records are both relevant and necessary to the litigation and that,
therefore, the use of such records by the DOJ, court or other tribunal
is deemed by HHS to be compatible with the purpose for which the agency
collected the records.
8. Records may be disclosed to student volunteers and other
individuals performing functions for the
[[Page 83249]]
Department but technically not having the status of agency employees,
if they need access to the records in order to perform their assigned
agency functions.
9. Disclosures may be made to the National Archives and Records
Administration (NARA) and/or the General Services Administration (GSA)
for the purpose of records management inspections conducted under 44
U.S.C. 2904 and 2906.
10. Information may be disclosed to a Member of Congress or a
Congressional staff member in response to a written inquiry of the
Congressional office made at the written request of the constituent
about whom the record is maintained. The Congressional office does not
have any greater authority to obtain records than the individual would
have if requesting the records directly.
11. Records may be disclosed to the U.S. 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.
12. Disclosures may be made to appropriate federal agencies and
Department contractors that have a need to know the information for the
purpose of assisting the Department's efforts to respond to a suspected
or confirmed breach of the security or confidentiality of information
maintained in this system of records, when the information disclosed is
relevant and necessary to that assistance.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM--
STORAGE:
Records are stored in hard-copy files and electronic media.
RETRIEVABILITY:
Records are retrieved by the individual's name.
SAFEGUARDS:
Safeguards conform to the HHS Information Security and Privacy
Program, https://www.hhs.gov/ocio/securityprivacy/.
Information is safeguarded in accordance with applicable laws, rules
and policies, including the HHS Information Technology Security Program
Handbook, all pertinent National Institutes of Standards and Technology
(NIST) publications, and OMB Circular A-130, Management of Federal
Resources. Records are protected from unauthorized access through
appropriate administrative, physical, and technical safeguards. These
safeguards include protecting the facilities where records are stored
or accessed with security guards, badges and cameras, securing hard-
copy records in locked file cabinets, file rooms or offices during off-
duty hours, limiting access to electronic databases to authorized users
based on roles and two-factor authentication (user ID and password),
using a secured operating system protected by encryption, firewalls,
and intrusion detection systems, requiring encryption for records
stored on removable media, and training personnel in Privacy Act and
information security requirements. Records that are eligible for
destruction are disposed of using destruction methods prescribed by
NIST SP 800-88.
RETENTION AND DISPOSAL:
Records pertaining to recruitment and use of outside peer reviewers
are destroyed three years after final action; they are retained longer
if required for business use (see General Records Schedule (GRS) 1.2,
Item 010, Grant and Cooperative Agreement Program Management Records).
Records pertaining to recruitment and use of other outside individuals
(e.g., experts, patient advocates, and members of mission-related non-
FACA committees) are currently unscheduled. Unscheduled records must be
retained indefinitely pending the agency's submission, and NARA's
approval, of a disposition schedule. HHS anticipates proposing to NARA,
as an appropriate retention period for these records, ``three years
after final action, or longer if required for business use'' (similar
to the period provided in GRS 1.2, Item 010) or ``when no longer needed
for administrative purposes'' (similar to the periods applicable to
similar records not retrieved by personal identifier which are not
covered under this SORN; i.e.: N1-442-93-1, Item 37 for the Agency for
Toxic Substances and Disease Registry's Curriculum Vitae Files, and
NC1-235-82-1, Item 100-3 for the Office of the Secretary's Advisory
Committee Candidate Resume Files).
SYSTEM MANAGER(S) AND ADDRESS(ES):
For CDC/NCHS Consultant Records:
Centers for Disease Control and Prevention (CDC),
Director, National Center for Health Statistics, OPHSS, Prince George's
Metro IV Bldg., Rm. 7209, MS P08, Centers for Disease Control and
Prevention, 3311 Toledo Road, Hyattsville, MD 20782
For FDA Patient Representative Records:
Food and Drug Administration (FDA), Advisory Committee
Oversight & Management Staff, 10903 New Hampshire Avenue, Bldg. WO32,
Rm. 5129, Silver Spring, MD 20993-002
For ACF Peer Reviewer Records:
Administration for Children and Families (ACF), Privacy
Act Contact, Office of Information Systems 330 C Street, NW.,
Washington, DC 20201
For HRSA Peer Reviewer Records:
Health Resources and Services Administration (HRSA),
Chief, Policy, Analysis & Training Branch, Division of Independent
Review, Office of Federal Assistance Management, 5600 Fishers Lane,
Rockville, MD 20857
For SAMHSA Peer Reviewer Records:
Substance Abuse and Mental Health Services Administration
(SAMHSA), Director, Division of Grant Review, 5600 Fishers lane,
Rockville, MD 20852
For Other Consultant Records, Maintained by SAMHSA Contractors:
Substance Abuse and Mental Health Services Administration
(SAMHSA), Director, Division of Contracts Management, Office of Program
Services, 5600 Fishers Lane, Rockville, MD 20852
NOTIFICATION PROCEDURE:
An individual who wishes to know if this system contains records
about him or her should submit a written request to the relevant System
Manager indicated above. The individual 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 for acquisition of a
record pertaining to an individual under false pretenses is a criminal
offense under the Privacy Act, subject to a five thousand dollar fine.
RECORD ACCESS PROCEDURE:
An individual seeking access to records about him in this system
should submit a request following the same procedure indicated under
``Notification Procedure.''
CONTESTING RECORD PROCEDURE:
An individual seeking to amend the content of information about him
or her in this system should contact the relevant System Manager
indicated above and reasonably identify the record, specify the
information contested, state the corrective action sought, and provide
the reasons for the amendment, with supporting justification.
RECORD SOURCE CATEGORIES:
Most information is obtained directly from the individual record
subject.
[[Page 83250]]
Information pertaining to references and recommendations is obtained
from other private individuals, educational institutions, current and
former employers, HHS program personnel, biographical reference books,
private organizations, Members of Congress, and other government
sources.
EXEMPTIONS CLAIMED FOR THE SYSTEM:
None.
[FR Doc. 2016-27959 Filed 11-18-16; 8:45 am]
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