Privacy Act of 1974; Implementation, 58607-58608 [2015-24791]
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Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations
(C) Instructions on all available modes
or states of the device;
(D) Instructions on all safety features
of the device; and
(E) Validated methods and
instructions for reprocessing/
disinfecting any reusable components;
(iii) A detailed summary of the
mechanical compatibility testing
including:
(A) A table with a complete list of
compatible catheters tested
(manufacturer trade name and model
number), and
(B) A table with detailed test results,
including type of test, acceptance
criteria, and test results (i.e., pass for
meeting acceptance criteria);
(iv) A detailed summary of the in vivo
testing including:
(A) A table with a complete list of
compatible catheters used during testing
(manufacturer trade name and model
number);
(B) Adverse events encountered
pertinent to use of the device under use
conditions;
(C) A detailed summary of the deviceand procedure-related complications;
and
(D) A summary of study outcomes and
endpoints. Information pertinent to the
fluoroscopy times/exposure for the
procedure, patient, and operator
fluoroscopic exposure;
(v) Other labeling items:
(A) A detailed summary of pertinent
non-clinical testing information: EMC,
mechanical, electrical, and sterilization
of device and components;
(B) A detailed summary of the device
technical parameters; and
(C) An expiration date/shelf life and
storage conditions for the sterile
accessories; and
(vi) When available, and according to
the timeframe included in the PMS
protocol agreed upon with FDA, provide
a detailed summary of the PMS data
including:
(A) Updates to the labeling to
accurately reflect outcomes or necessary
modifications based upon data collected
during the PMS experience, and
(B) Inclusion of results and adverse
events associated with utilization of the
device during the PMS.
Dated: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–24624 Filed 9–29–15; 8:45 am]
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 311
[Docket ID: DoD–2015–OS–0077]
Privacy Act of 1974; Implementation
Office of the Secretary, DoD.
Direct final rule with request for
comments.
AGENCY:
ACTION:
The Office of the Secretary of
Defense (OSD) is exempting those
records contained in DPFPA 07, entitled
‘‘Counterintelligence Management
Information System (CIMIS),’’
pertaining to investigatory material
compiled for counterintelligence and
law enforcement purposes (under (k)(2)
of the Act), other than material within
the scope of subsection (j)(2) of the
Privacy Act to enable the protection of
identities of confidential sources who
might not otherwise come forward and
who furnished information under an
express promise that the sources’
identity would be held in confidence.
The exemption will allow DoD to
provide protection against notification
of investigatory material including
certain reciprocal investigations which
might alert a subject to the fact that an
investigation of that individual is taking
place, and the disclosure of which
would weaken the on-going
investigation, reveal investigatory
techniques, and place confidential
informants in jeopardy who furnished
information under an express promise
that the sources’ identity would be held
in confidence. Further, requiring OSD to
grant access to records and amend these
records would unfairly impede the
investigation of allegations of unlawful
activities. To require OSD to confirm or
deny the existence of a record
pertaining to a requesting individual
may in itself provide an answer to that
individual relating to an on-going
investigation. The investigation of
possible unlawful activities would be
jeopardized by agency rules requiring
verification of record, disclosure of the
record to the subject, and record
amendment procedures.
DATES: The rule will be effective on
December 9, 2015 unless adverse
comments are received by November 30,
2015. If adverse comment is received,
the Department of Defense will publish
a timely withdrawal of the rule in the
Federal Register.
ADDRESSES: You may submit comments,
identified by docket number and title,
by any of the following methods:
SUMMARY:
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58607
• Federal Rulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Department of Defense, Office
of the Deputy Chief Management
Officer, Directorate of Oversight and
Compliance, Regulatory and Audit
Matters Office, 9010 Defense Pentagon,
Washington, DC 20301–9010.
Instructions: All submissions received
must include the agency name and
docket number for this Federal Register
document. The general policy for
comments and other submissions from
members of the public is to make these
submissions available for public
viewing on the Internet at https://
www.regulations.gov as they are
received without change, including any
personal identifiers or contact
information.
FOR FURTHER INFORMATION CONTACT:
Ms.
Cindy Allard at (571) 372–0461.
This
direct final rule makes changes to the
Office of the Secretary Privacy Program
rules. These changes will allow the
Department to add an exemption rule to
the Office of the Secretary of Defense
Privacy Program rules that will exempt
applicable Department records and/or
material from certain portions of the
Privacy Act.
This rule is being published as a
direct final rule as the Department of
Defense does not expect to receive any
adverse comments, and so a proposed
rule is unnecessary.
SUPPLEMENTARY INFORMATION:
Direct Final Rule and Significant
Adverse Comments
DoD has determined this rulemaking
meets the criteria for a direct final rule
because it involves non-substantive
changes dealing with DoD’s
management of its Privacy Programs.
DoD expects no opposition to the
changes and no significant adverse
comments. However, if DoD receives a
significant adverse comment, the
Department will withdraw this direct
final rule by publishing a notice in the
Federal Register. A significant adverse
comment is one that explains: (1) Why
the direct final rule is inappropriate,
including challenges to the rule’s
underlying premise or approach; or (2)
why the direct final rule will be
ineffective or unacceptable without a
change. In determining whether a
comment necessitates withdrawal of
this direct final rule, DoD will consider
whether it warrants a substantive
response in a notice and comment
process.
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58608
Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Rules and Regulations
Executive Order 12866, ‘‘Regulatory
Planning and Review’’ and Executive
Order 13563, ‘‘Improving Regulation
and Regulatory Review’’
It has been determined that Privacy
Act rules for the Department of Defense
are not significant rules. This rule does
not (1) Have an annual effect on the
economy of $100 million or more or
adversely affect in a material way the
economy; a sector of the economy;
productivity; competition; jobs; the
environment; public health or safety; or
State, local, or tribal governments or
communities; (2) Create a serious
inconsistency or otherwise interfere
with an action taken or planned by
another Agency; (3) Materially alter the
budgetary impact of entitlements,
grants, user fees, or loan programs, or
the rights and obligations of recipients
thereof; or (4) Raise novel legal or policy
issues arising out of legal mandates, the
President’s priorities, or the principles
set forth in these Executive orders.
Public Law 96–354, ‘‘Regulatory
Flexibility Act’’ (5 U.S.C. Chapter 6)
It has been determined that this
Privacy Act rule for the Department of
Defense does not have significant
economic impact on a substantial
number of small entities because it is
concerned only with the administration
of Privacy Act systems of records within
the Department of Defense. A
Regulatory Flexibility Analysis is not
required.
mstockstill on DSK4VPTVN1PROD with RULES
Public Law 96–511, ‘‘Paperwork
Reduction Act’’ (44 U.S.C. Chapter 35)
It has been determined that this
Privacy Act rule for the Department of
Defense imposes no information
requirements beyond the Department of
Defense and that the information
collected within the Department of
Defense is necessary and consistent
with 5 U.S.C. 552a, known as the
Privacy Act of 1974.
Section 202, Public Law 104–4,
‘‘Unfunded Mandates Reform Act’’
It has been determined that this
Privacy Act rule for the Department of
Defense does not involve a Federal
mandate that may result in the
expenditure by State, local and tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
and that this rulemaking will not
significantly or uniquely affect small
governments.
Executive Order 13132, ‘‘Federalism’’
It has been determined that this
Privacy Act rule for the Department of
Defense does not have federalism
implications. This rule does not have
VerDate Sep<11>2014
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substantial direct effects on the States,
on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Therefore, no
Federalism assessment is required.
List of Subjects in 32 CFR Part 311
Privacy.
Accordingly, 32 CFR part 311 is
amended to read as follows:
PART 311—OFFICE OF THE
SECRETARY OF DEFENSE AND JOINT
STAFF PRIVACY PROGRAM
1. The authority citation for 32 CFR
part 311 continues to read as follows:
■
Authority: 5 U.S.C. 522a.
2. Section 311.8 is amended by adding
paragraph (c)(25) to read as follows:
■
§ 311.8
Procedures for exemptions.
*
*
*
*
*
(c) * * *
(25) System identifier and name:
DPFPA 07, Counterintelligence
Management Information System
(CIMIS).
(i) Exemptions: Portions of this
system that fall within 5 U.S.C. 552a
(k)(2) are exempt from the following
provisions of 5 U.S.C. 552a, section
(c)(3); (d); (e)(1); (e)(4) (G) through (I);
and (f) of the Act, as applicable.
(ii) Authority: 5 U.S.C. 552a(k)(2).
(iii) Reasons:
(A) From subsections (c)(3) because
making available to a record subject the
accounting of disclosure from records
concerning him or her would
specifically reveal any investigative
interest in the individual. Revealing this
information could reasonably be
expected to compromise ongoing efforts
to investigate a known or suspected
offender by notifying the record subject
that he or she is under investigation.
This information could also permit the
record subject to take measures to
impede the investigation, e.g., destroy
evidence, intimidate potential
witnesses, or flee the area to avoid or
impede the investigation.
(B) From subsection (d) because these
provisions concern individual access to
and amendment of certain records
contained in this system, including
counterintelligence, law enforcement,
and investigatory records. Compliance
with these provisions could alert the
subject of an investigation of the fact
and nature of the investigation, and/or
the investigative interest of agencies;
compromise sensitive information
related to national security; interfere
with the overall counterintelligence and
PO 00000
Frm 00036
Fmt 4700
Sfmt 9990
investigative process by leading to the
destruction of evidence, improper
influencing of witnesses, fabrication of
testimony, and/or flight of the subject;
could identify a confidential source or
disclose information which would
constitute an unwarranted invasion of
another’s personal privacy; reveal a
sensitive investigation or constitute a
potential danger to the health or safety
of law enforcement personnel,
confidential informants, and witnesses.
Amendment of these records would
interfere with ongoing
counterintelligence investigations and
analysis activities and impose an
excessive administrative burden by
requiring investigations, analyses, and
reports to be continuously
reinvestigated and revised.
(C) From subsection (e)(1) because it
is not always possible to determine
what information is relevant and
necessary at an early stage in a given
investigation. Also, because Pentagon
Force Protection Agency and other
agencies may not always know what
information about a known or suspected
offender may be relevant to for the
purpose of conducting an operational
response.
(D) From subsections (e)(4)(G) through
(I) (Agency Requirements) because
portions of this system are exempt from
the access and amendment provisions of
subsection (d).
(E) From subsection (f) because
requiring the Agency to grant access to
records and establishing agency rules
for amendment of records would
compromise the existence of any
criminal, civil, or administrative
enforcement activity. To require the
confirmation or denial of the existence
of a record pertaining to a requesting
individual may in itself provide an
answer to that individual relating to the
existence of an on-going investigation.
Counterintelligence investigations
would be jeopardized by agency rules
requiring verification of the record,
disclosure of the record to the subject,
and record amendment procedures.
Dated: July 31, 2015.
Aaron Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2015–24791 Filed 9–29–15; 8:45 am]
BILLING CODE 5001–06–P
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Agencies
[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Rules and Regulations]
[Pages 58607-58608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24791]
=======================================================================
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 311
[Docket ID: DoD-2015-OS-0077]
Privacy Act of 1974; Implementation
AGENCY: Office of the Secretary, DoD.
ACTION: Direct final rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: The Office of the Secretary of Defense (OSD) is exempting
those records contained in DPFPA 07, entitled ``Counterintelligence
Management Information System (CIMIS),'' pertaining to investigatory
material compiled for counterintelligence and law enforcement purposes
(under (k)(2) of the Act), other than material within the scope of
subsection (j)(2) of the Privacy Act to enable the protection of
identities of confidential sources who might not otherwise come forward
and who furnished information under an express promise that the
sources' identity would be held in confidence. The exemption will allow
DoD to provide protection against notification of investigatory
material including certain reciprocal investigations which might alert
a subject to the fact that an investigation of that individual is
taking place, and the disclosure of which would weaken the on-going
investigation, reveal investigatory techniques, and place confidential
informants in jeopardy who furnished information under an express
promise that the sources' identity would be held in confidence.
Further, requiring OSD to grant access to records and amend these
records would unfairly impede the investigation of allegations of
unlawful activities. To require OSD to confirm or deny the existence of
a record pertaining to a requesting individual may in itself provide an
answer to that individual relating to an on-going investigation. The
investigation of possible unlawful activities would be jeopardized by
agency rules requiring verification of record, disclosure of the record
to the subject, and record amendment procedures.
DATES: The rule will be effective on December 9, 2015 unless adverse
comments are received by November 30, 2015. If adverse comment is
received, the Department of Defense will publish a timely withdrawal of
the rule in the Federal Register.
ADDRESSES: You may submit comments, identified by docket number and
title, by any of the following methods:
Federal Rulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Department of Defense, Office of the Deputy Chief
Management Officer, Directorate of Oversight and Compliance, Regulatory
and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-
9010.
Instructions: All submissions received must include the agency name
and docket number for this Federal Register document. The general
policy for comments and other submissions from members of the public is
to make these submissions available for public viewing on the Internet
at https://www.regulations.gov as they are received without change,
including any personal identifiers or contact information.
FOR FURTHER INFORMATION CONTACT: Ms. Cindy Allard at (571) 372-0461.
SUPPLEMENTARY INFORMATION: This direct final rule makes changes to the
Office of the Secretary Privacy Program rules. These changes will allow
the Department to add an exemption rule to the Office of the Secretary
of Defense Privacy Program rules that will exempt applicable Department
records and/or material from certain portions of the Privacy Act.
This rule is being published as a direct final rule as the
Department of Defense does not expect to receive any adverse comments,
and so a proposed rule is unnecessary.
Direct Final Rule and Significant Adverse Comments
DoD has determined this rulemaking meets the criteria for a direct
final rule because it involves non-substantive changes dealing with
DoD's management of its Privacy Programs. DoD expects no opposition to
the changes and no significant adverse comments. However, if DoD
receives a significant adverse comment, the Department will withdraw
this direct final rule by publishing a notice in the Federal Register.
A significant adverse comment is one that explains: (1) Why the direct
final rule is inappropriate, including challenges to the rule's
underlying premise or approach; or (2) why the direct final rule will
be ineffective or unacceptable without a change. In determining whether
a comment necessitates withdrawal of this direct final rule, DoD will
consider whether it warrants a substantive response in a notice and
comment process.
[[Page 58608]]
Executive Order 12866, ``Regulatory Planning and Review'' and Executive
Order 13563, ``Improving Regulation and Regulatory Review''
It has been determined that Privacy Act rules for the Department of
Defense are not significant rules. This rule does not (1) Have an
annual effect on the economy of $100 million or more or adversely
affect in a material way the economy; a sector of the economy;
productivity; competition; jobs; the environment; public health or
safety; or State, local, or tribal governments or communities; (2)
Create a serious inconsistency or otherwise interfere with an action
taken or planned by another Agency; (3) Materially alter the budgetary
impact of entitlements, grants, user fees, or loan programs, or the
rights and obligations of recipients thereof; or (4) Raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in these Executive orders.
Public Law 96-354, ``Regulatory Flexibility Act'' (5 U.S.C. Chapter 6)
It has been determined that this Privacy Act rule for the
Department of Defense does not have significant economic impact on a
substantial number of small entities because it is concerned only with
the administration of Privacy Act systems of records within the
Department of Defense. A Regulatory Flexibility Analysis is not
required.
Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter 35)
It has been determined that this Privacy Act rule for the
Department of Defense imposes no information requirements beyond the
Department of Defense and that the information collected within the
Department of Defense is necessary and consistent with 5 U.S.C. 552a,
known as the Privacy Act of 1974.
Section 202, Public Law 104-4, ``Unfunded Mandates Reform Act''
It has been determined that this Privacy Act rule for the
Department of Defense does not involve a Federal mandate that may
result in the expenditure by State, local and tribal governments, in
the aggregate, or by the private sector, of $100 million or more and
that this rulemaking will not significantly or uniquely affect small
governments.
Executive Order 13132, ``Federalism''
It has been determined that this Privacy Act rule for the
Department of Defense does not have federalism implications. This rule
does not have substantial direct effects on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Therefore, no Federalism assessment is required.
List of Subjects in 32 CFR Part 311
Privacy.
Accordingly, 32 CFR part 311 is amended to read as follows:
PART 311--OFFICE OF THE SECRETARY OF DEFENSE AND JOINT STAFF
PRIVACY PROGRAM
0
1. The authority citation for 32 CFR part 311 continues to read as
follows:
Authority: 5 U.S.C. 522a.
0
2. Section 311.8 is amended by adding paragraph (c)(25) to read as
follows:
Sec. 311.8 Procedures for exemptions.
* * * * *
(c) * * *
(25) System identifier and name: DPFPA 07, Counterintelligence
Management Information System (CIMIS).
(i) Exemptions: Portions of this system that fall within 5 U.S.C.
552a (k)(2) are exempt from the following provisions of 5 U.S.C. 552a,
section (c)(3); (d); (e)(1); (e)(4) (G) through (I); and (f) of the
Act, as applicable.
(ii) Authority: 5 U.S.C. 552a(k)(2).
(iii) Reasons:
(A) From subsections (c)(3) because making available to a record
subject the accounting of disclosure from records concerning him or her
would specifically reveal any investigative interest in the individual.
Revealing this information could reasonably be expected to compromise
ongoing efforts to investigate a known or suspected offender by
notifying the record subject that he or she is under investigation.
This information could also permit the record subject to take measures
to impede the investigation, e.g., destroy evidence, intimidate
potential witnesses, or flee the area to avoid or impede the
investigation.
(B) From subsection (d) because these provisions concern individual
access to and amendment of certain records contained in this system,
including counterintelligence, law enforcement, and investigatory
records. Compliance with these provisions could alert the subject of an
investigation of the fact and nature of the investigation, and/or the
investigative interest of agencies; compromise sensitive information
related to national security; interfere with the overall
counterintelligence and investigative process by leading to the
destruction of evidence, improper influencing of witnesses, fabrication
of testimony, and/or flight of the subject; could identify a
confidential source or disclose information which would constitute an
unwarranted invasion of another's personal privacy; reveal a sensitive
investigation or constitute a potential danger to the health or safety
of law enforcement personnel, confidential informants, and witnesses.
Amendment of these records would interfere with ongoing
counterintelligence investigations and analysis activities and impose
an excessive administrative burden by requiring investigations,
analyses, and reports to be continuously reinvestigated and revised.
(C) From subsection (e)(1) because it is not always possible to
determine what information is relevant and necessary at an early stage
in a given investigation. Also, because Pentagon Force Protection
Agency and other agencies may not always know what information about a
known or suspected offender may be relevant to for the purpose of
conducting an operational response.
(D) From subsections (e)(4)(G) through (I) (Agency Requirements)
because portions of this system are exempt from the access and
amendment provisions of subsection (d).
(E) From subsection (f) because requiring the Agency to grant
access to records and establishing agency rules for amendment of
records would compromise the existence of any criminal, civil, or
administrative enforcement activity. To require the confirmation or
denial of the existence of a record pertaining to a requesting
individual may in itself provide an answer to that individual relating
to the existence of an on-going investigation.
Counterintelligence investigations would be jeopardized by agency
rules requiring verification of the record, disclosure of the record to
the subject, and record amendment procedures.
Dated: July 31, 2015.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2015-24791 Filed 9-29-15; 8:45 am]
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