Privacy Act of 1974; Implementation, 22807-22808 [2011-9747]
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Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations
submitting a 510(k) premarket
notification for a TOCE will need to
address the issues covered in the special
controls guidance. However, the firm
need only show that its device meets the
recommendations of the guidance or in
some other way provides equivalent
assurances of safety and effectiveness.
Section 510(m) of the FD&C Act
(21 U.S.C. 360(m)) provides that FDA
may exempt a class II device from the
premarket notification requirements
under section 510(k) of the FD&C Act if
FDA determines that premarket
notification is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device. FDA has
determined that premarket notification
is necessary to provide reasonable
assurance of the safety and effectiveness
of the TOCE and, therefore, this device
type is not exempt from premarket
notification requirements.
jdjones on DSKHWCL6B1PROD with RULES
V. Environmental Impact
The agency has determined under
21 CFR 25.34(b) that this reclassification
action is of a type that does not
individually or cumulatively have a
significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
VI. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act
(5 U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4). Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). The
agency believes that this final rule is not
a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because the final rule
reclassifying this device from class III to
class II will relieve all manufacturers of
the device of the cost of complying with
the premarket approval requirements of
section 515 of the FD&C Act, it will
impose no significant economic impact
on any small entities, and it may permit
small potential competitors to enter the
marketplace by lowering their costs, and
the agency certifies that the final rule
will not have a significant economic
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impact on a substantial number of small
entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is
$135 million, using the most current
(2009) Implicit Price Deflator for the
Gross Domestic Product. FDA does not
expect this final rule to result in any
1-year expenditure that would meet or
exceed this amount.
VII. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. Section 4(a)
of the Executive order requires agencies
to ‘‘construe * * * a Federal statute to
preempt State law only where the
statute contains an express preemption
provision or there is some other clear
evidence that the Congress intended
preemption of State law, or where the
exercise of State law conflicts with the
exercise of Federal authority under the
Federal statute.’’ Federal law includes
an express preemption provision that
preempts certain State requirements
‘‘different from or in addition to’’ certain
Federal requirements applicable to
devices. (See section 521 of the FD&C
Act (21 U.S.C. 360k); Medtronic Inc., v.
Lohr, 518 U.S. 470 (1996); Riegel v.
Medtronic Inc., 128 S. Ct. 999 (2008)).
The special controls established by this
final rule create ‘‘requirements’’ for
specific medical devices under
21 U.S.C. 360k, even though product
sponsors have some flexibility in how
they meet those requirements. See
Papike v. Tambrands, Inc., 107 F.3d
737, 740–742 (9th Cir. 1997).
VIII. Paperwork Reduction Act of 1995
This final rule contains no collections
of information. Therefore, clearance by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3520) is not required. FDA concludes
that the special controls guidance
document identified by this rule
contains information collection
provisions that are subject to review and
clearance by OMB under the PRA.
Elsewhere in this issue of the Federal
Register, FDA is publishing a notice
announcing the availability of the
guidance document entitled, ‘‘Class II
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22807
Special Controls Guidance Document:
Topical Oxygen Chamber for
Extremities.’’ The notice contains an
analysis of the paperwork burden for the
guidance.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 878 is
amended as follows:
PART 878—GENERAL AND PLASTIC
SURGERY DEVICES
1. The authority citation for 21 CFR
part 878 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Section 878.5650 is revised to read
as follows:
■
§ 878.5650 Topical oxygen chamber for
extremities.
(a) Identification. A topical oxygen
chamber for extremities is a device that
is intended to surround a patient’s limb
and apply humidified oxygen topically
at a pressure slightly greater than
atmospheric pressure to aid healing of
chronic skin ulcers such as bedsores.
(b) Classification. Class II (special
controls). The special control for this
device is FDA’s ‘‘Class II Special
Controls Guidance: Topical Oxygen
Chamber for Extremities.’’ See § 878.1(e)
for the availability of this guidance
document.
Dated: April 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–9899 Filed 4–22–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DoD–2011–OS–0008]
32 CFR Part 321
Privacy Act of 1974; Implementation
Defense Security Service, DoD.
Direct final rule with request for
comments.
AGENCY:
ACTION:
The Defense Security Service
is deleting an exemption rule for V5–05
entitled ‘‘Joint Personnel Adjudication
System (JPAS)’’ in its entirety. The
system has been transferred to the Office
of the Secretary of Defense.
This direct final rule makes
nonsubstantive changes to the Defense
SUMMARY:
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22808
Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations
jdjones on DSKHWCL6B1PROD with RULES
Security Service Privacy Program rules.
These changes will allow the
Department to transfer this system to
another organization within the
Department. This will improve the
efficiency and effectiveness of DoD’s
program by preserving the exempt status
of the records when the purposes
underlying the exemption are valid and
necessary to protect the contents of the
records.
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.
DATES: The rule will be effective on July
5, 2011 unless comments are received
that would result in a contrary
determination. Comments will be
accepted on or before June 24, 2011.
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: Federal Docket Management
System Office, Room 3C843, 1160
Defense Pentagon, Washington, DC
20301–1160.
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: Mr.
Leslie Blake at (703) 325–9450.
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 nonsubstantive
changes dealing with DoD’s
management of its Privacy Progams.
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
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comment necessitates withdrawal of
this direct final rule, DoD will consider
whether it warrants a substantive
response in a notice and comment
process.
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. The rules do
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.
The rules do 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.
List of Subjects in 32 CFR Part 321
Privacy.
Accordingly, 32 CFR 321 is amended
as follows:
PART 321—DEFENSE SECURITY
SERVICE PRIVACY PROGRAM
1. The authority citation for 32 CFR
part 321 continues to read as follows:
■
Authority: Pub. L. 93–579, 88 Stat. 1896
(5 U.S.C. 552a).
2. In § 321.13, remove and reserve
paragraph (h) to read as follows:
■
§ 321.13
*
Exemptions.
*
*
*
(h) [Reserved].
*
Dated: April 8, 2011.
Patricia Topping,
OSD Federal Register Liaison Officer,
Department of Defense.
[FR Doc. 2011–9747 Filed 4–22–11; 8:45 am]
Public Law 96–354, ‘‘Regulatory
Flexibility Act’’ (5 U.S.C. Chapter 6)
It has been determined that Privacy
Act rules for the Department of Defense
do not have significant economic impact
on a substantial number of small entities
because they are concerned only with
the administration of Privacy Act
systems of records within the
Department of Defense.
BILLING CODE 5001–06–P
Public Law 96–511, ‘‘Paperwork
Reduction Act’’ (44 U.S.C. Chapter 35)
It has been determined that Privacy
Act rules for the Department of Defense
impose no additional information
collection requirements on the public
under the Paperwork Reduction Act of
1995.
AGENCY:
Section 202, Public Law 104–4,
‘‘Unfunded Mandates Reform Act’’
It has been determined that Privacy
Act rulemaking 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 such rulemaking will not
significantly or uniquely affect small
governments.
Executive Order 13132, ‘‘Federalism’’
It has been determined that Privacy
Act rules for the Department of Defense
do not have federalism implications.
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DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DoD–2011–OS–0009]
32 CFR Part 323
Privacy Act of 1974; Implementation
Defense Logistics Agency, DoD.
Direct final rule with request for
comments.
ACTION:
The Department of Defense is
updating the Defense Logistics Agency
Privacy Act Program Rules, by adding
the exemption rules (j)(2), (k)(2), (k)(3),
(k)(4), (k)(5), (k)(6), and (k)(7) for
S510.30, Freedom of Information Act/
Privacy Act Requests and
Administrative Appeal Records to
accurately describe the basis for
exempting the records. The S510.30
system of records notice was printed on
January 22, 2009 in the Federal
Register.
This direct final rule makes
nonsubstantive changes to the Defense
Logistics Agency Privacy Program rules.
These changes will allow the
Department to exempt records from
certain portions of the Privacy Act. This
will improve the efficiency and
effectiveness of DoD’s program by
preserving the exempt status of the
SUMMARY:
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]]>Agencies
[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Rules and Regulations]
[Pages 22807-22808]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9747]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DoD-2011-OS-0008]
32 CFR Part 321
Privacy Act of 1974; Implementation
AGENCY: Defense Security Service, DoD.
ACTION: Direct final rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: The Defense Security Service is deleting an exemption rule for
V5-05 entitled ``Joint Personnel Adjudication System (JPAS)'' in its
entirety. The system has been transferred to the Office of the
Secretary of Defense.
This direct final rule makes nonsubstantive changes to the Defense
[[Page 22808]]
Security Service Privacy Program rules. These changes will allow the
Department to transfer this system to another organization within the
Department. This will improve the efficiency and effectiveness of DoD's
program by preserving the exempt status of the records when the
purposes underlying the exemption are valid and necessary to protect
the contents of the records.
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.
DATES: The rule will be effective on July 5, 2011 unless comments are
received that would result in a contrary determination. Comments will
be accepted on or before June 24, 2011.
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: Federal Docket Management System Office, Room 3C843,
1160 Defense Pentagon, Washington, DC 20301-1160.
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: Mr. Leslie Blake at (703) 325-9450.
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 nonsubstantive changes dealing with
DoD's management of its Privacy Progams. 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.
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. The rules do 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 Privacy Act rules for the Department of
Defense do not have significant economic impact on a substantial number
of small entities because they are concerned only with the
administration of Privacy Act systems of records within the Department
of Defense.
Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter 35)
It has been determined that Privacy Act rules for the Department of
Defense impose no additional information collection requirements on the
public under the Paperwork Reduction Act of 1995.
Section 202, Public Law 104-4, ``Unfunded Mandates Reform Act''
It has been determined that Privacy Act rulemaking 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 such rulemaking will not significantly or uniquely affect small
governments.
Executive Order 13132, ``Federalism''
It has been determined that Privacy Act rules for the Department of
Defense do not have federalism implications. The rules do 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.
List of Subjects in 32 CFR Part 321
Privacy.
Accordingly, 32 CFR 321 is amended as follows:
PART 321--DEFENSE SECURITY SERVICE PRIVACY PROGRAM
0
1. The authority citation for 32 CFR part 321 continues to read as
follows:
Authority: Pub. L. 93-579, 88 Stat. 1896 (5 U.S.C. 552a).
0
2. In Sec. 321.13, remove and reserve paragraph (h) to read as
follows:
Sec. 321.13 Exemptions.
* * * * *
(h) [Reserved].
Dated: April 8, 2011.
Patricia Topping,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2011-9747 Filed 4-22-11; 8:45 am]
BILLING CODE 5001-06-P
