Privacy Act of 1974; Implementation, 44382-44383 [E7-15455]
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Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Rules and Regulations
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
V. 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 (PRA) of 1995 is not required.
Elsewhere in this issue of the Federal
Register, FDA is publishing a notice
announcing the availability of the
guidance document entitled ‘‘Class II
Special Controls Guidance Document:
In Vitro HIV Drug Resistance Genotype
Assay.’’ FDA concludes that the special
controls guidance document contains
information collection provisions that
are subject to review by the OMB under
the PRA and that have been approved
by OMB in accordance with the PRA
under the regulations governing
premarket notification submissions (part
807, subpart E, OMB control number
0910–0120).
VI. References
1. Petition from Visible Genetics, Inc.,
dated July 11, 2001.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, Medical
devices.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 866 is
amended as follows:
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for 21 CFR
part 866 continues to read as follows:
I
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Add § 866.3950 to subpart D to read
as follows:
I
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§ 866.3950 In vitro human
immunodeficiency virus (HIV) drug
resistance genotype assay.
(a) Identification. The in vitro HIV
drug resistance genotype assay is a
device that consists of nucleic acid
reagent primers and probes together
with software for predicting drug
resistance/susceptibility based on
results obtained with these primers and
15:29 Aug 07, 2007
Dated: August 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–15475 Filed 8–7–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF JUSTICE
28 CFR Part 16
[AAG/A Order No. 023–2007]
Privacy Act of 1974; Implementation
Department of Justice.
ACTION: Final Rule.
AGENCY:
The following reference has been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
VerDate Aug<31>2005
probes. It is intended for use in
detecting HIV genomic mutations that
confer resistance to specific
antiretroviral drugs, as an aid in
monitoring and treating HIV infection.
(b) Classification. Class II (special
controls). The special control for this
device is FDA’s guidance document
entitled ‘‘Class II Special Controls
Guidance Document: In Vitro HIV Drug
Resistance Genotype Assay.’’ See
§ 866.1(e) for the availability of this
guidance document.
Jkt 211001
SUMMARY: On May 8, 2007, at 72 FR
26037, the Department of Justice issued
a proposed rule to amend Title 28 of the
Code of Federal Regulations, Part 16, to
exempt the following new system of
records from certain provisions of the
Privacy Act: The National Security
Division (NSD), ‘‘Foreign Intelligence
and Counterintelligence Records System
(JUSTICE/NSD–001),’’ which
incorporated three previous systems of
records of the Office of Intelligence
Policy and Review (OIPR). This records
system must be exempted from sections
of the Privacy Act since, in most cases,
disclosure of the existence of records
pertaining to an individual would
hinder authorized United States
intelligence activities by informing that
individual of the existence, nature, or
scope of information that is properly
classified pursuant to Executive Order
12958, as amended, and thereby cause
damage to the national security. Further
it is necessary to exempt this system to
ensure unhampered and effective
collection and analysis of foreign
intelligence and counterintelligence
information and to protect the identities
of confidential sources.
EFFECTIVE DATE: This final rule is
effective August 8, 2007.
FOR FURTHER INFORMATION CONTACT:
GayLa Sessoms, (202) 616–5460 or Mary
Cahill (202) 307–1823.
SUPPLEMENTARY INFORMATION: The notice
of the proposed rule with invitation to
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comment was published in the Federal
Register on May 8, 2007, at 72 FR
26073. No comments were received. The
Department of Justice is exempting
JUSTICE/NSD–001 from 5 U.S.C.
552a(c)(3) and (4); (d); (e)(1), (2), (3),
(4)(G), (H), and (I), (5) and (8); (f); (g);
and (h).
This order relates to individuals
rather than small business entities.
Nevertheless, pursuant to the
requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601–612, this
order will not have a significant impact
on a substantial number of small
business entities.
List of Subjects in 28 CFR Part 16
Administrative Practices and
Procedures, Courts, Freedom of
Information, and Privacy.
I Pursuant to the authority vested in the
Attorney General by 5 U.S.C. 552a and
delegated to me by Attorney General
Order No. 793–78, amend 28 CFR part
16 as follows:
PART 16—PRODUCTION OR
DISCLOSURE OF MATERIAL OR
INFORMATION
1. The authority for part 16 continues
to read as follows:
I
Authority: 5 U.S.C. 301, 551, 552a, 552b(g),
and 553; 18 U.S.C. 4203(a)(1); 28 U.S.C. 509,
510, 534; 31 U.S.C. 3717, and 9701.
2. Section 16. 74 is revised to read as
follows:
I
§ 16.74 Exemption of National Security
Division Systems—limited access.
(a) The following system of records is
exempted from subsections (c)(3) and
(4); (d); (e)(1), (2), (3), (4)(G),(H) and (I),
(5) and (8); (f); (g); and (h) of the Privacy
Act pursuant to 5 U.S.C. 552a(j)(2),
(k)(1), (2) and (5): Foreign Intelligence
and Counterintelligence Records System
(JUSTICE/NSD–001). These exemptions
apply only to the extent that
information in the system is subject to
exemption pursuant to 5 U.S.C.
552a(j)(2), (k)(1), (2), and (5).
(b) Exemptions from the particular
subsections are justified for the
following reasons:
(1) Subsection (c)(3). To provide the
target of a surveillance or collection
activity with the disclosure accounting
records concerning him or her would
hinder authorized United States
intelligence activities by informing that
individual of the existence, nature, or
scope of information that is properly
classified pursuant to Executive Order
12958, as amended, and thereby cause
damage to the national security.
(2) Subsection (c)(4). This subsection
is inapplicable to the extent that an
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08AUR1
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Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Rules and Regulations
exemption is being claimed for
subsection (d).
(3) Subsection (d)(1). Disclosure of
foreign intelligence and
counterintelligence information would
interfere with collection activities,
reveal the identity of confidential
sources, and cause damage to the
national security of the United States.
To ensure unhampered and effective
collection and analysis of foreign
intelligence and counterintelligence
information, disclosure must be
precluded.
(4) Subsection (d)(2). Amendment of
the records would interfere with
ongoing intelligence activities thereby
causing damage to the national security.
(5) Subsections (d)(3) and (4). These
subsections are inapplicable to the
extent exemption is claimed from (d)(1)
and (2).
(6) Subsection (e)(1). It is often
impossible to determine in advance if
intelligence records contained in this
system are relevant and necessary, but,
in the interests of national security, it is
necessary to retain this information to
aid in establishing patterns of activity
and provide intelligence leads.
(7) Subsection (e)(2). Although this
office does not conduct investigations,
the collection efforts of agencies that
supply information to this office would
be thwarted if the agencies were
required to collect information with the
subject’s knowledge.
(8) Subsection (e)(3). To inform
individuals as required by this
subsection could reveal the existence of
collection activity and compromise
national security. For example, a target
could, once made aware that collection
activity exists, alter his or her manner
of engaging in intelligence or terrorist
activities in order to avoid detection.
(9) Subsections (e)(4)(G), (H) and (I),
and (f). These subsections are
inapplicable to the extent that this
system is exempt from the access
provisions of subsection (d).
(10) Subsection (e)(5). It is often
impossible to determine in advance if
intelligence records contained in this
system are accurate, relevant, timely
and complete, but, in the interests of
national security, it is necessary to
retain this information to aid in
establishing patterns of activity and
providing intelligence leads.
(11) Subsection (e)(8). Serving notice
could give persons sufficient warning to
evade intelligence collection and antiterrorism efforts.
(12) Subsections (g) and (h). These
subsections are inapplicable to the
extent that this system is exempt from
other specific subsections of the Privacy
Act.
VerDate Aug<31>2005
15:29 Aug 07, 2007
Jkt 211001
Dated: July 27, 2007.
Lee J. Lofthus,
Assistant Attorney General for
Administration.
[FR Doc. E7–15455 Filed 8–7–07; 8:45 am]
BILLING CODE 4410–AW–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 81
[EPA–R05–OAR–2006–0459; FRL–8450–3]
Determination of Attainment, Approval
of Designation of Areas for Air Quality
Planning Purposes; Indiana;
Correction
Environmental Protection
Agency (EPA).
ACTION: Final rule; correcting
amendment.
AGENCY:
SUMMARY: This document corrects errors
in the final rule redesignating LaPorte
County, Indiana (LaPorte CO., IN) to
attainment for the 8-hour ozone
National Ambient Air Quality Standard
(NAAQS). In the final approval for the
redesignation of this area, EPA
inadvertently titled the designation
codification table as ‘‘OHIO OZONE’’
instead of ‘‘Indiana-Ozone’’, and
inadvertently specified the effective
date of this action in the designation
table as August 20, 2007, even though
the effective date of the final rule was
July 19, 2007, as specified in the DATES
portion of the final rule. This technical
correction to the final rule corrects these
errors.
DATES: Effective Date: This final rule is
effective on August 8, 2007.
FOR FURTHER INFORMATION CONTACT:
Edward Doty, Environmental Scientist,
Criteria Pollutant Section, Air Programs
Branch (AR–18J), Environmental
Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604,
(312) 886–6057, doty.edward@epa.gov.
SUPPLEMENTARY INFORMATION: EPA
published a notice of final rulemaking
to redesignate LaPorte County, Indiana
(LaPorte CO., IN) to attainment of the 8hour ozone standard on July 19, 2007
(72 FR 39574). In the designation
codification table used to revise the 8hour ozone designation of this area, EPA
incorrectly titled the table as ‘‘OHIO
OZONE.’’ This should have read as
‘‘Indiana-Ozone.’’ In the same
designation codification table, EPA
incorrectly specified the effective date
of the redesignation as August 20, 2007.
This differed from the actual effective
date of the final rule, July 19, 2007, as
specified in the DATES section of the
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44383
final rule. EPA intended to make the
redesignation of this area effective upon
the date of the publication of the final
rule.
Correction
For LaPorte County in the final rule
published in the Federal Register on
July 19, 2007 (72 FR 39574), on page
39576 in the codification table, the table
title: ‘‘OHIO OZONE’’ is corrected to
read ‘‘Indiana-Ozone’’. In the second
column of the same codification table,
the Date: ‘‘8/20/07’’ is corrected to read
‘‘7/19/07’’. EPA is making changes in 40
CFR 81.315 in order to correct the
codification of the 8-hour ozone
designation for LaPorte County, Indiana.
Section 553 of the Administrative
Procedure Act, 5 U.S.C. 553(b)(B),
provides that, when an agency for good
cause finds that notice and public
procedure are impracticable,
unnecessary or contrary to the public
interest, the agency may issue a rule
without providing notice and an
opportunity for public comment. We
have determined that there is good
cause for making today’s rule final
without prior proposal and opportunity
for comment because we are merely
correcting errors in a previous action.
Thus, notice and public procedure are
unnecessary. We find that this
constitutes good cause under 5 U.S.C.
553(b)(B).
Statutory and Executive Order Reviews
Under Executive Order 12866 (58 FR
51735, October 4, 1993), this action is
not a ‘‘significant regulatory action’’ and
is, therefore, not subject to review by the
Office of Management and Budget. For
this reason, this action is also not
subject to Executive Order 13211,
‘‘Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355 (May
22, 2001)). Because the agency has made
a ‘‘good cause’’ finding that this action
is not subject to notice-and-comment
requirements under the Administrative
Procedures Act or any other statute as
indicated in the SUPPLEMENTARY
INFORMATION section above, it is not
subject to the regulatory flexibility
provisions of the Regulatory Flexibility
Act (5 U.S.C 601 et seq.), or to sections
202 and 205 of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L.
104–4). In addition, this action does not
significantly or uniquely affect small
governments or impose a significant
intergovernmental mandate, as
described in sections 203 and 204 of
UMRA. This rule also does not have a
substantial direct effect on one or more
Indian tribes, on the relationship
between the Federal Government and
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08AUR1
Agencies
[Federal Register Volume 72, Number 152 (Wednesday, August 8, 2007)]
[Rules and Regulations]
[Pages 44382-44383]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15455]
=======================================================================
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DEPARTMENT OF JUSTICE
28 CFR Part 16
[AAG/A Order No. 023-2007]
Privacy Act of 1974; Implementation
AGENCY: Department of Justice.
ACTION: Final Rule.
-----------------------------------------------------------------------
SUMMARY: On May 8, 2007, at 72 FR 26037, the Department of Justice
issued a proposed rule to amend Title 28 of the Code of Federal
Regulations, Part 16, to exempt the following new system of records
from certain provisions of the Privacy Act: The National Security
Division (NSD), ``Foreign Intelligence and Counterintelligence Records
System (JUSTICE/NSD-001),'' which incorporated three previous systems
of records of the Office of Intelligence Policy and Review (OIPR). This
records system must be exempted from sections of the Privacy Act since,
in most cases, disclosure of the existence of records pertaining to an
individual would hinder authorized United States intelligence
activities by informing that individual of the existence, nature, or
scope of information that is properly classified pursuant to Executive
Order 12958, as amended, and thereby cause damage to the national
security. Further it is necessary to exempt this system to ensure
unhampered and effective collection and analysis of foreign
intelligence and counterintelligence information and to protect the
identities of confidential sources.
EFFECTIVE DATE: This final rule is effective August 8, 2007.
FOR FURTHER INFORMATION CONTACT: GayLa Sessoms, (202) 616-5460 or Mary
Cahill (202) 307-1823.
SUPPLEMENTARY INFORMATION: The notice of the proposed rule with
invitation to comment was published in the Federal Register on May 8,
2007, at 72 FR 26073. No comments were received. The Department of
Justice is exempting JUSTICE/NSD-001 from 5 U.S.C. 552a(c)(3) and (4);
(d); (e)(1), (2), (3), (4)(G), (H), and (I), (5) and (8); (f); (g); and
(h).
This order relates to individuals rather than small business
entities. Nevertheless, pursuant to the requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601-612, this order will not have a
significant impact on a substantial number of small business entities.
List of Subjects in 28 CFR Part 16
Administrative Practices and Procedures, Courts, Freedom of
Information, and Privacy.
0
Pursuant to the authority vested in the Attorney General by 5 U.S.C.
552a and delegated to me by Attorney General Order No. 793-78, amend 28
CFR part 16 as follows:
PART 16--PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION
0
1. The authority for part 16 continues to read as follows:
Authority: 5 U.S.C. 301, 551, 552a, 552b(g), and 553; 18 U.S.C.
4203(a)(1); 28 U.S.C. 509, 510, 534; 31 U.S.C. 3717, and 9701.
0
2. Section 16. 74 is revised to read as follows:
Sec. 16.74 Exemption of National Security Division Systems--limited
access.
(a) The following system of records is exempted from subsections
(c)(3) and (4); (d); (e)(1), (2), (3), (4)(G),(H) and (I), (5) and (8);
(f); (g); and (h) of the Privacy Act pursuant to 5 U.S.C. 552a(j)(2),
(k)(1), (2) and (5): Foreign Intelligence and Counterintelligence
Records System (JUSTICE/NSD-001). These exemptions apply only to the
extent that information in the system is subject to exemption pursuant
to 5 U.S.C. 552a(j)(2), (k)(1), (2), and (5).
(b) Exemptions from the particular subsections are justified for
the following reasons:
(1) Subsection (c)(3). To provide the target of a surveillance or
collection activity with the disclosure accounting records concerning
him or her would hinder authorized United States intelligence
activities by informing that individual of the existence, nature, or
scope of information that is properly classified pursuant to Executive
Order 12958, as amended, and thereby cause damage to the national
security.
(2) Subsection (c)(4). This subsection is inapplicable to the
extent that an
[[Page 44383]]
exemption is being claimed for subsection (d).
(3) Subsection (d)(1). Disclosure of foreign intelligence and
counterintelligence information would interfere with collection
activities, reveal the identity of confidential sources, and cause
damage to the national security of the United States. To ensure
unhampered and effective collection and analysis of foreign
intelligence and counterintelligence information, disclosure must be
precluded.
(4) Subsection (d)(2). Amendment of the records would interfere
with ongoing intelligence activities thereby causing damage to the
national security.
(5) Subsections (d)(3) and (4). These subsections are inapplicable
to the extent exemption is claimed from (d)(1) and (2).
(6) Subsection (e)(1). It is often impossible to determine in
advance if intelligence records contained in this system are relevant
and necessary, but, in the interests of national security, it is
necessary to retain this information to aid in establishing patterns of
activity and provide intelligence leads.
(7) Subsection (e)(2). Although this office does not conduct
investigations, the collection efforts of agencies that supply
information to this office would be thwarted if the agencies were
required to collect information with the subject's knowledge.
(8) Subsection (e)(3). To inform individuals as required by this
subsection could reveal the existence of collection activity and
compromise national security. For example, a target could, once made
aware that collection activity exists, alter his or her manner of
engaging in intelligence or terrorist activities in order to avoid
detection.
(9) Subsections (e)(4)(G), (H) and (I), and (f). These subsections
are inapplicable to the extent that this system is exempt from the
access provisions of subsection (d).
(10) Subsection (e)(5). It is often impossible to determine in
advance if intelligence records contained in this system are accurate,
relevant, timely and complete, but, in the interests of national
security, it is necessary to retain this information to aid in
establishing patterns of activity and providing intelligence leads.
(11) Subsection (e)(8). Serving notice could give persons
sufficient warning to evade intelligence collection and anti-terrorism
efforts.
(12) Subsections (g) and (h). These subsections are inapplicable to
the extent that this system is exempt from other specific subsections
of the Privacy Act.
Dated: July 27, 2007.
Lee J. Lofthus,
Assistant Attorney General for Administration.
[FR Doc. E7-15455 Filed 8-7-07; 8:45 am]
BILLING CODE 4410-AW-P