[Federal Register Volume 87, Number 213 (Friday, November 4, 2022)]
[Notices]
[Pages 66711-66714]
[FR Doc No: 2022-24072]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]

Revocation of Two Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection and/or Diagnosis of COVID-19;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Cleveland Clinic Robert J. Tomsich Pathology
and Laboratory Medicine Institute (Cleveland Clinic) for the Cleveland
Clinic SARS-CoV-2 Assay and SelfCheck COVID-19 TaqPath Multiplex PCR.
FDA revoked these Authorizations under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). The revocations, which include an explanation
of the reasons for each revocation, are reprinted in this document.

DATES: The Authorizations for the Cleveland Clinic SARS-CoV-2 Assay and
SelfCheck COVID-19 TaqPath Multiplex PCR are revoked as of October 19,
2022.

ADDRESSES: Submit written requests for a single copy of the revocations
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocations may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. On August 3, 2020, FDA issued an EUA to Cleveland Clinic
for the Cleveland Clinic SARS-CoV-2 Assay, subject to the terms of the
Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on November 20, 2020 (85 FR 74346),
as required by section 564(h)(1) of the FD&C Act. On August 9, 2021,
FDA issued an EUA to Cleveland Clinic for the SelfCheck COVID-19
TaqPath Multiplex PCR, subject to the terms of the Authorization.
Notice of the issuance of this Authorization was published in the
Federal Register on October 28, 2021 (86 FR 59738), as required by
section 564(h)(1) of the FD&C Act. Subsequent updates to the
Authorizations were made available on FDA's website. The authorization
of a device for emergency use under section 564 of the FD&C Act may,
pursuant to section 564(g)(2) of the FD&C Act, be revoked when the
criteria under section 564(c) of the FD&C Act for issuance of such
authorization are no longer met (section 564(g)(2)(B) of the FD&C Act),
or other circumstances make such revocation appropriate to protect the
public health or safety (section 564(g)(2)(C) of the FD&C Act).

II. EUA Revocation Requests

    In a request received by FDA on October 7, 2022, Cleveland Clinic
requested revocation of, and on October 19, 2022, FDA revoked, the
Authorization for the Cleveland Clinic SARS-CoV-2 Assay. Because
Cleveland Clinic notified FDA that it is no longer using the Cleveland
Clinic SARS-CoV-2 Assay and does not plan to use it in the future and
requested FDA revoke the EUA for the Cleveland Clinic SARS-CoV-2 Assay,
FDA has determined that it is appropriate to protect the public health
or safety to revoke this Authorization.
    In a request received by FDA on October 7, 2022, Cleveland Clinic
requested revocation of, and on October 19, 2022, FDA revoked, the
Authorization for the SelfCheck COVID-19 TaqPath Multiplex PCR. Because
Cleveland Clinic notified FDA that it is no longer using the SelfCheck
COVID-19 TaqPath Multiplex PCR and does not plan to use it in the
future and requested FDA revoke the EUA for the SelfCheck COVID-19
TaqPath Multiplex PCR, FDA has determined that it is appropriate to
protect the public health or safety to revoke this Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/.

IV. The Revocations

    Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUAs of Cleveland Clinic for the Cleveland Clinic SARS-
CoV-2 Assay and SelfCheck COVID-19 TaqPath Multiplex PCR. The
revocations in their entirety follow and provide an explanation of the
reasons for each revocation, as required by section 564(h)(1) of the
FD&C Act.
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TN04NO22.074

[GRAPHIC] [TIFF OMITTED] TN04NO22.075

    Dated: October 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24072 Filed 11-3-22; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Notices]
[Pages 21307-21308]
[FR Doc No: 2014-08586]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, April
17, 2014 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matter at the Closed Meeting.
    Commissioner Gallagher, as duty officer, voted to consider the
items listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting will be:
    Institution and settlement of injunctive actions;

    institution and settlement of administrative proceedings; an
adjudicatory matter; and
    other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: April 10, 2014.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2014-08586 Filed 4-11-14; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 13 (Tuesday, January 21, 2014)]
[Notices]
[Page 3425]
[FR Doc No: 2014-00991]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Form F-4; OMB Control No. 3235-0325, SEC File No. 270-
288.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Form F-4 (17 CFR 239.34) is used by foreign issuers to register
securities in business combinations, reorganizations and exchange
offers pursuant to the Securities Act of 1933 (15 U.S.C. 77a et seq.).
The information collected is intended to ensure that the information
required to be filed by the Commission permits verification of
compliance with securities law requirements and assures the public
availability of such information. Form F-4 takes approximately 1,447
hours per response and is filed by approximately 68 respondents. We
estimate that 25% of the 1,447 hours per response (361.75 hours) is
prepared by the registrant for a total annual reporting burden of
24,599 hours (361.75 hours per response x 68 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.
    Please direct your written comment to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: January 14, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-00991 Filed 1-17-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 59 (Thursday, March 27, 2014)]
[Proposed Rules]
[Pages 17077-17082]
[FR Doc No: 2014-06591]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 40

[Docket No. RM13-19-000, RM14-3-000]

Generator Relay Loadability and Revised Transmission Relay
Loadability Reliability Standards

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of proposed rulemaking.

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SUMMARY: Pursuant to section 215 of the Federal Power Act, the
Commission proposes to approve a new Reliability Standard, PRC-025-1
(Generator Relay Loadability), submitted by the North American Electric
Reliability Corporation (NERC), the Commission-approved Electric
Reliability Organization. In addition, the Commission proposes to
approve Reliability Standard PRC-023-3 (Transmission Relay
Loadability), also submitted by NERC, which revises a currently-
effective standard pertaining to transmission relay loadability.

DATES: Comments are due April 28, 2014.

ADDRESSES: Comments, identified by docket number, may be filed in the
following ways:
     Electronic Filing through http://www.ferc.gov. Documents
created electronically using word processing software should be filed
in native applications or print-to-PDF format and not in a scanned
format.
     Mail/Hand Delivery: Those unable to file electronically
may mail or hand-deliver comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Comment
Procedures Section of this document.

FOR FURTHER INFORMATION CONTACT:
Syed Ahmad (Technical Information), Office of Electric Reliability,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>Julie Greenisen (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

146 FERC ] 61,189

Before Commissioners: Cheryl A. LaFleur, Acting Chairman; Philip D.
Moeller, John R. Norris, and Tony Clark.

(Issued March 20, 2014)

    1. Pursuant to section 215 of the Federal Power Act (FPA),\1\ the
Commission proposes to approve a new Reliability Standard, PRC-025-1
(Generator Relay Loadability), submitted by the North American Electric
Reliability Corporation (NERC). In addition, the Commission proposes to
approve Reliability Standard PRC-023-3 (Transmission Relay
Loadability), also submitted by NERC, which revises a currently-
effective standard pertaining to transmission relay loadability.
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 824o (2012).
---------------------------------------------------------------------------

    2. NERC developed proposed Reliability Standard PRC-025-1 in
response to certain Commission directives issued in Order No. 733,\2\
in which the Commission approved an initial version of a Reliability
Standard governing transmission relay loadability. We believe that the
proposed new standard on generator relay loadability, Reliability
Standard PRC-025-1, will serve to enhance reliability by imposing
mandatory requirements governing generator relay loadability, thereby
reducing the likelihood of premature or unnecessary tripping of
generators during system disturbances. In addition, we believe that the
proposed revisions to PRC-023-2 are appropriate in that they clarify
the applicability of the two standards governing relay loadability
(PRC-025-1 and PRC-023-3), and prevent potential compliance overlap due
to inconsistencies. Finally, we propose to approve the violation risk
factors and violation severity levels as proposed for PRC-025-1, as
well as the proposed implementation plans for the two standards.
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    \2\ Transmission Relay Loadability Reliability Standard, Order
No. 733, 130 FERC ] 61,221 (2010) (Order No. 733); order on reh'g
and clarification, Order No. 733-A, 134 FERC ] 61,127; clarified,
Order No. 733-B, 136 FERC ] 61,185 (2011).
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I. Background

A. Regulatory Background

    3. Section 215 of the FPA requires a Commission-certified Electric
Reliability Organization (ERO) to develop mandatory and enforceable
Reliability Standards, subject to Commission review and approval.\3\
Once approved, the Reliability Standards may be enforced by the ERO
subject to Commission oversight, or by the Commission independently.\4\
In 2006, the Commission certified NERC as the ERO pursuant to FPA
section 215.\5\
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    \3\ 16 U.S.C. 824o(c) and (d).
    \4\ See id. at 824o(e).
    \5\ North American Electric Reliability Corp., 116 FERC ]
61,062, order on reh'g & compliance, 117 FERC ] 61,126 (2006), aff'd
sub nom., Alcoa, Inc. v. FERC, 564 F.3d 1342 (D.C. Cir. 2009).
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B. Relay Protection Systems

    4. Protective relays are devices that detect and initiate the
removal of faults on an electric system.\6\ They are designed to read
electrical measurements, such as current, voltage, and frequency, and
can be set to recognize certain measurements as indicating a fault.
When a protective relay detects a fault on an element of the system
under its protection, it sends a signal to an interrupting device, such
as a circuit breaker, to disconnect the element from the rest of the
system. Impedance relays, which are the most common type of relays used
to protect transmission lines, continuously measure voltage and current
on the protected transmission line and operate when the measured
magnitude and

phase angle of the impedance (voltage/current) falls within the
settings of the relay.
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    \6\ A ``fault'' is defined in the NERC Glossary of Terms used in
Reliability Standards as ``[a]n event occurring on an electric
system such as a short circuit, a broken wire, or an intermittent
connection.''
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C. Development of Reliability Standards on Relay Loadability

    5. Following the August 2003 blackout that affected parts of the
Midwest, the Northeast, and Ontario, Canada, NERC and the U.S.-Canada
Power System Outage Task Force (Task Force) concluded that a
substantial number of transmission lines disconnected during the
blackout when load-responsive phase-protection backup distance and
phase relays operated unnecessarily, i.e. under non-fault conditions.
Although these relays operated according to their settings, the Task
Force determined that the operation of these relays for non-fault
conditions contributed to cascading outages at the start of the
blackout and accelerated the geographic spread of the cascade.\7\
Seeking to prevent or minimize the scope of future blackouts, both NERC
and the Task Force developed recommendations to ensure that these types
of protective relays do not contribute to future blackouts.\8\
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    \7\ U.S.-Canada Power System Outage Task Force, Final Report on
the August 14, 2003 Blackout in the United States and Canada: Causes
and Recommendations, at 80 (2004) (Final Blackout Report).
    \8\ See Final Blackout Report, Recommendation 21A; North
American Electric Reliability Council, August 14, 2003 Blackout:
NERC Actions to Prevent and Mitigate the Impacts of Future Cascading
Blackouts, at 13 and Recommendation 8a (2004).
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    6. NERC developed Reliability Standard PRC-023-1 (Transmission
Relay Loadability) to address these recommendations, and submitted it
for Commission approval under FPA section 215. On March 10, 2010, in
Order No. 733, the Commission approved Reliability Standard PRC-023-
1.\9\ In addition, the Commission directed NERC to (1) make certain
modifications to the Reliability Standard, (2) submit a timeline for
the development of a new Reliability Standard to address generator
protective relay loadability, and (3) develop a new Reliability
Standard addressing the issue of protective relay operation during
stable power swings.
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    \9\ Order No. 733, 130 FERC ] 61,221.
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D. NERC Petition and Proposed Standards PRC-025-1 and PRC-023-3

1. Proposed Reliability Standard PRC-025-1
    7. On September 30, 2013, NERC submitted a petition seeking
approval of Reliability Standard PRC-025-1 (Generator Relay
Loadability).\10\ NERC states in its petition that the proposed
standard ``is designed to prevent generator tripping when conditions do
not pose a direct risk to the generator and associated equipment and
will reduce the risk of unnecessary generator tripping--events that
increase the severity of the disturbance.'' \11\ NERC further states
that the proposed standard is intended to address the second part of
the Commission's Order No. 733 directives, requiring development of a
standard governing generator protective relay loadability.\12\ NERC
notes that it addressed the first Order No. 733 directive, requiring
modification of PRC-023-1, through its revised standard PRC-023-2
(currently in effect).\13\ NERC indicates that it is addressing the
third portion of the Order No. 733 directives, relay operation during
stable power swings, as part of a separate phase of the project.\14\
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    \10\ Proposed Reliability Standards PRC-025-1 and PRC-023-3 are
not attached to this Notice of Proposed Rulemaking. The complete
texts of these proposed Reliability Standards are available on the
Commission's eLibrary document retrieval system in Docket Nos. RM13-
19-000 and RM14-3-000, and are posted on NERC's Web site, available
at: http://www.nerc.com.
    \11\ Petition of the North American Electric Reliability Corp.
for Approval of Proposed Reliability Standard PRC-025-1 (Generator
Relay Loadability), Docket No. RM13-19-000, at 4 (Sept. 30, 2013)
(Sept. 30 Petition or Petition). NERC requested that the Commission
delay its consideration of PRC-025-1 until NERC could finalize and
submit for approval certain related revisions to its transmission
relay loadability standard, PRC-023-2. Those revisions were
submitted on Dec. 17, 2013, as discussed further below.
    \12\ See id. at 8.
    \13\ Id. (citing Transmission Relay Loadability Reliability
Standard, Order No. 759, 138 FERC ] 61,197 (2012)).
    \14\ Id. NERC indicated that this third phase of its response to
Order No. 733 is tentatively scheduled to be completed in December
2014. Id.
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    8. The stated purpose of PRC-025-1 is ``[t]o set load-responsive
protective relays associated with generation Facilities at a level to
prevent unnecessary tripping of generators during a system disturbance
for conditions that do not pose a risk of damage to the associated
equipment.'' \15\ Proposed Reliability Standard PRC-025-1 would apply
to any generator owner, transmission owner, or distribution provider
``that applies load-responsive protective relays at the terminals of
the Elements listed in 3.2, Facilities.'' \16\ ``Facilities,'' in turn,
are defined in section 3.2 of the proposed standard as:
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    \15\ Sept. 30 Petition, Ex. A at 3. While NERC has not proposed
a definition for the term ``load-responsive protective relays,''
Attachment A of existing Reliability Standard PRC-023-2, which also
uses the term ``load-responsive protective relays'' states that the
standard includes ``any protective functions which could trip with
or without time delay, on load current.'' NERC Reliability Standard
PRC-023-2, available at http://www.nerc.com/_layouts/PrintStandard.aspx?standardnumber=PRC-023-2&title=Transmission%20Relay%20Loadability&jurisdiction=United%20States.
    \16\ Sept. 30 Petition, Ex. A at 3. NERC further explains that
the standard should ``include all load-responsive protective relays
that are affected by increased generator output in response to
system disturbances.'' Sept. 30 Petition, Ex. A at 25 (Guidelines
and Technical Basis) (hereinafter Guidelines).

    Elements associated with Bulk Electric System (BES) generating
units and generating plants, including those * * * identified as
Blackstart Resources in the Transmission Operator's system
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restoration plan:

    3.2.1 Generating unit(s).
    3.2.2 Generator step-up (i.e., GSU) transformer(s).
    3.2.3 Unit auxiliary transformer(s) (UAT) that supply overall
auxiliary power necessary to keep generating unit(s) online.
    3.2.4 Elements that connect the GSU transformer(s) to the
Transmission system that are used exclusively to export energy
directly from a BES generating unit or generating plant. Elements
may also supply generating plant loads.
    3.2.5 Elements utilized in the aggregation of dispersed power
producing resources.

    9. Proposed Reliability Standard PRC-025-1 has only one
requirement, that each applicable entity ``shall apply settings that
are in accordance with PRC-025-1--Attachment 1: Relay Settings, on each
load-responsive protective relay while maintaining reliable fault
protection.'' \17\ The relay setting options are defined in Table 1 of
Attachment 1, and include the specific bus voltage and other inputs to
be used depending on the application (e.g., synchronous or asynchronous
generator, generator step-up transformer, or unit auxiliary
transformer) and the type of relay. For most applications of each type
of relay, the proposed standard would give applicable entities the
option of adopting relay settings that meet the stated criteria as
determined through (1) a relatively simple calculation, (2) a more
complex calculation, or (3) a described simulation. As stated in the
standard, the criteria in Attachment 1 ``represent short-duration
conditions during which generation Facilities are capable of providing
system reactive resources, and for which generation Facilities have
been historically recorded to disconnect, causing events to become more
severe.'' \18\
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    \17\ Id. 18, and Ex. A at 4.
    \18\ Id., Ex. A at 4 (Rationale for R1).
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    10. NERC further explains in its petition that the specific relay
setting criteria are based on system conditions observed during the
August 2003 Blackout.\19\ The criteria for relays applied on
synchronous generators, and

their associated generator step-up transformers (GSUs) and connecting
elements, are based on the response of the synchronous generator to
depressed transmission system voltage (with allowances for reactive
power losses across the GSU transformer). The criteria for relays
applied on asynchronous generators and their associated GSU
transformers and connecting elements are based on the more limited
response of an asynchronous generator to the depressed voltage (with no
allowance for loss of reactive power across the GSU transformer because
such losses are not significant).\20\ The criteria for relays applied
on unit auxiliary transformers (UATs) that supply station service are
based on the increased current requirements of station service load
during a depressed voltage condition.
---------------------------------------------------------------------------

    \19\ Id. 10.
    \20\ Id. 11.
---------------------------------------------------------------------------

    11. In its justification for approval of the proposed standard,
NERC explains that ``[a]nalyses of power system disturbances over the
past twenty-five years have found generators to have tripped
unnecessarily--an occurrence that has the potential to extend the scope
and duration of a disturbance.'' \21\ According to NERC, during the
recovery phase of a disturbance, system voltage may be widely depressed
and may fluctuate. To support the system during this phase of a
disturbance, NERC explains that the proposed standard ``establishes
criteria for setting load-responsive relays such that individual
generators may provide Reactive Power within their dynamic capability
during transient time periods,'' thereby avoiding unnecessary tripping
of generators and ensuring that ``dynamic capability is available to
support system recovery.'' \22\
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    \21\ Id. 9.
    \22\ Id. 9-10.
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    12. NERC proposes Requirement R1 of PRC-025-1 be assigned a
``High'' violation risk factor, and a ``Severe'' violation severity
level for failure to apply settings as required. NERC's Implementation
Plan proposes that applicable entities must be in compliance with the
new standard: (1) 60 months after regulatory approval where compliance
can be achieved without replacement or removal of relays; or (2) 84
months after regulatory approval if replacement or removal of relays is
necessary.\23\
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    \23\ See Sept. 30 Petition, Ex. B (Implementation Plan).
---------------------------------------------------------------------------

2. Proposed Reliability Standard PRC-023-3
    13. On December 17, 2013, NERC submitted proposed clarifying
changes to Reliability Standard PRC-023-2, as reflected in PRC-023-3,
as ``Supplemental Information'' to its Sept. 30 Petition.\24\ NERC
explains in its Supplemental Filing that these changes were identified
during development of PRC-025-1 as ``necessary to establish a bright-
line distinction between the applicability of load-responsive
protective relays in the transmission and generator relay loadability
Reliability Standards.'' \25\ NERC explains that stakeholders became
concerned about potential compliance overlap between the new generator
relay loadability standard, PRC-025-1, and existing standard PRC-023-2,
which currently applies to certain elements that connect GSU
transformers to the transmission system.
---------------------------------------------------------------------------

    \24\ Supplemental Information to the Petition of the North
American Electric Reliability Corp. for Approval of Proposed
Reliability Standard PRC-025-1 (Generator Relay Loadability), Docket
No. RM14-3-000 (Dec. 17, 2013) (Supplemental Filing).
    \25\ Id. 1-2.
---------------------------------------------------------------------------

    14. In order to clarify that proposed standard PRC-025-1 is
intended to cover ``all load responsive protective relays applied at
the terminals of generators and GSU transformers,'' \26\ NERC proposes
to remove Criteria 6 of Requirement R1 from PRC-023-2 in its entirety.
That sub-requirement currently requires applicable entities to:
---------------------------------------------------------------------------

    \26\ See id. at 4.

    Set transmission line relays applied on transmission lines
connected to generation stations remote to load so they do not
operate at or below 230% of the aggregated generation nameplate
capability.\27\
---------------------------------------------------------------------------

    \27\ See Supplemental Filing, Ex. A, Redline of PRC-023-2 at 6.

NERC also proposes to change the applicability section of PRC-023-2 to
exclude ``Elements that connect the GSU transformer(s) to the
Transmission system that are used exclusively to export energy directly
from a BES generating unit or generating plant.'' \28\
---------------------------------------------------------------------------

    \28\ See Supplemental Filing at 4, and Ex. A, Proposed
Reliability Standard PRC-023-3, Sections <IP_ADDRESS> and <IP_ADDRESS>.
---------------------------------------------------------------------------

    15. NERC explains in its Supplemental Filing that the two relay
loadability standards, as revised, would be based on the location where
the relays are applied and not on the intended protection functions,
which it believes is advantageous because it:

    (i) Facilitates the establishment of generator relay loadability
requirements based on the physics associated with increased
generator output during stressed system conditions.
    (ii) Avoids ambiguity as to whether the intended protection
function is for the generating unit or the Transmission System. . .
.
    (iii) Provides clear division of applicability between the
Generator and Transmission Relay Loadability Reliability Standards
based on the physical location, independent of the entity that owns
the relay.\29\
---------------------------------------------------------------------------

    \29\ Supplemental Filing at 5.

    16. Under NERC's proposed implementation plan, Reliability Standard
PRC-023-3 will become effective on the first day of the first calendar
quarter beyond the date that the standard is approved by the applicable
regulatory authority. Reliability Standard PRC-023-2 would be retired
immediately prior to the effective date of PRC-023-3, except that
Criterion 6 of Requirement R1 would remain in effect until the
effective date of PRC-025-1. Any implementation dates or milestones
established under PRC-023-2 would remain in place.\30\
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    \30\ As part of its Supplemental Filing, NERC also submitted a
report on UAT relay loadability to address concerns raised by
minority commenters during the development of PRC-025-1 as to
whether UAT relays on the low-voltage side should be included. See
id. at 6 and Ex. E. The report concludes that there is no adverse
reliability impact from Reliability Standard PRC-025-1 as proposed,
and finds that ``based on a comparison of the simulation models and
the actual event data, the simulation results are conservative. The
model results, coupled with the NERC Generating Availability Data
System (GADS) analysis, are indicative that a reliability gap does
not result from excluding relays on the low-voltage side of the UAT
from PRC-025-1.'' Supplemental Filing at 6, Ex. E at 6.
---------------------------------------------------------------------------

II. Discussion

    17. Pursuant to section 215(d)(2) of the FPA, the Commission
proposes to approve Reliability Standard PRC-025-1, including its
associated violation risk factors and violation severity levels,
Reliability Standard PRC-023-3, and NERC's proposed implementation
plans for the new and revised standards. PRC-025-1 appears to
adequately address the Commission directive in Order No. 733 that NERC
develop a separate Reliability Standard that addresses generator step-
up and auxiliary transformer loadability, and do so ``in a way that is
coordinated with the Requirements and expected outcomes of PRC-023-1.''
\31\ In addition, we believe that PRC-025-1 will enhance reliability by
imposing mandatory requirements governing generator relay loadability
settings, thereby reducing the likelihood of premature or unnecessary
tripping of generators during system disturbances.
---------------------------------------------------------------------------

    \31\ See Order No. 733, 130 FERC ] 61,221 at PP 104-106.
---------------------------------------------------------------------------

    18. We also propose to approve the clarifying modifications
reflected in Reliability Standard PRC-023-3,

because we agree they serve to clarify the applicability of the two
standards governing relay loadability and prevent potential compliance
overlap due to inconsistencies.

III. Information Collection Statement

    19. The collection of information contained in this Notice of
Proposed Rulemaking is subject to review by the Office of Management
and Budget (OMB) under section 3507(d) of the Paperwork Reduction Act
of 1995.\32\ OMB's regulations require approval of certain information
collection requirements imposed by agency rules.\33\ Upon approval of a
collection(s) of information, OMB will assign an OMB control number and
an expiration date. Respondents subject to the filing requirements of a
rule will not be penalized for failing to respond to these collections
of information unless the collections of information display a valid
OMB control number.
---------------------------------------------------------------------------

    \32\ 44 U.S.C. 3507(d) (2012).
    \33\ 5 CFR 1320.11 (2013).
---------------------------------------------------------------------------

    20. We solicit comments on the need for this information, whether
the information will have practical utility, the accuracy of the burden
estimates, ways to enhance the quality, utility, and clarity of the
information to be collected or retained, and any suggested methods for
minimizing respondents' burden, including the use of automated
information techniques. Specifically, the Commission asks that any
revised burden or cost estimates submitted by commenters be supported
by sufficient detail to understand how the estimates are generated.
    21. The Commission proposes to approve Reliability Standard PRC-
025-1 and to approve revisions to PRC-023-2. Proposed Reliability
Standard PRC-025-1 will impose new requirements to set certain
generator protective relays in accordance with prescribed criteria, and
will apply to transmission owners, distribution providers, and
generator owners with applicable relays. Affected entities will have to
ensure that their relays are set in accordance with these criteria and
maintain records or other evidence demonstrating their compliance with
the standard's requirements. The revisions to PRC-023-2 will result in
a change in how relay settings are calculated for certain kinds of
relays, but will not result in reporting or recordkeeping requirements
or burden.
    Public Reporting Burden: Proposed Reliability Standard PRC-025-1
does not require responsible entities to file information with the
Commission. However, the Reliability Standard requires applicable
entities to develop and maintain certain information, subject to audit
by a Regional Entity. In particular, transmission owners, generator
owners and distribution providers must ``have evidence'' to show that
each of its load-responsive protective relays are set according to one
of the options in Attachment 1 to Reliability Standard PRC-025-1. Our
estimate below regarding the number of respondents is based on the NERC
compliance registry as of January 31, 2014. According to the NERC
compliance registry, NERC has registered 539 distribution providers,
903 generator owners and 344 transmission owners. However, under NERC's
compliance registration program, entities may be registered for
multiple functions, so these numbers incorporate some double counting.
The number of unique entities responding will be approximately 1,019
\34\ entities registered as a transmission owner, a distribution
provider, or a generator owner that is also a transmission owner and/or
a distribution owner. The Commission estimates the annual reporting
burden and cost as follows:
---------------------------------------------------------------------------

    \34\ This estimate assumes all of the unique entities apply
load-responsive protective relays.
    \35\ Normally these reporting and recordkeeping requirements
would be included under FERC-725G (OMB Control No. 1902-0252).
However, only one request per OMB Control Number can be pending OMB
review at a time. Because a pending and unrelated rulemaking also
affects other aspects of FERC-725G, the reporting and record
retention requirements for this NOPR in RM13-19 and RM14-3 will be
submitted to OMB for review under FERC-725Q.
    \36\ GO = Generator Owner, DP = Distribution Provider, TO =
Transmission Owner, each of whom applies load-responsive protective
relays at the terminals of the Elements listed (in the Standard)
3.2, Facilities.
    \37\ The estimated hourly costs (salary plus benefits) are based
on Bureau of Labor and Statistics (BLS) information (available at
http://bls.gov/oes/current/naics3_221000.htm#17-0000) for an
electrical engineer ($59.62/hour for review and documentation), and
for a file clerk ($28.95/hour for record retention).

                                                FERC-725Q, \35\ as Modified in NOPR in RM13-19 and RM14-3
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Annual number                                          Total annual burden
                                      Number and type of    of responses    Total number     Averge  burden and      hours and total        Cost per
                                       respondents \36\    per respondent   of responses     cost per response         annual cost       respondent \37\
                                    (1)..................             (2)                  (3)..................  (1) x (2) x (3).....
--------------------------------------------------------------------------------------------------------------------------------------------------------
(One-time) Review & documentation   1,019 GO/DP/TO.......               1           1,019  20 hrs. & $59.62/hour  20,380 hours &                   $1192
 of relay settings to ensure                                                                                $1,215,056.
 compliance.
(On-going) Record Retention (of     1,019 GO/DP/TO.......               1           1,019  2 hrs. & $28.95/hour.  2,038 hours &                   $57.90
 compliance records for R1 and M1,                                                                                $59,000.
 for 3 years or until mitigation
 complete).
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Title: Mandatory Reliability Standards for the Bulk-Power System.
    Action: Proposed FERC-725Q.
    OMB Control No: To Be Determined.
    Respondents: Businesses or other for-profit institutions; not-for-
profit institutions.
    Frequency of Responses: One-time and ongoing.
    Necessity of the Information: The Generator Relay Loadability
Reliability Standard, if adopted, would implement the Congressional
mandate of the Energy Policy Act of 2005 to develop mandatory and
enforceable Reliability Standards to better ensure the reliability of
the nation's Bulk-Power System. Specifically, the purpose of the
proposed Reliability Standard is to set load-responsive protective
relays associated with generation facilities at a level to prevent
unnecessary tripping of generators during a system disturbance for
conditions that do not pose a risk of damage to the associated
equipment. The proposed Reliability Standard requires entities to
maintain records subject to review by the Commission and NERC to ensure
compliance with the Reliability Standard.

    Internal Review: The Commission has reviewed the requirements
pertaining to the proposed Reliability Standard for the Bulk-Power
System and determined that the proposed requirements are necessary to
meet the statutory provisions of the Energy Policy Act of 2005. These
requirements conform to the Commission's plan for efficient information
collection, communication and management within the energy industry.
The Commission has assured itself, by means of internal review, that
there is specific, objective support for the burden estimates
associated with the information requirements.
    22. Interested persons may obtain information on the reporting
requirements by contacting the following: Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426 [Attention:
Ellen Brown, Office of the Executive Director, email:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>].
    23. Comments concerning the information collections proposed in
this NOPR and the associated burden estimates should be sent to the
Commission in these dockets and may also be sent to the Office of
Management and Budget, Office of Information and Regulatory Affairs
[Attention: Desk Officer for the Federal Energy Regulatory Commission].
For security reasons, comments should be sent by email to OMB at the
following email address<EMAIL_ADDRESS>Please reference
FERC-725Q and the docket numbers of this Notice of Proposed Rulemaking
(Docket Nos. RM13-19-000 and RM14-3-000) in your submission.

IV. Regulatory Flexibility Act Certification

    24. The Regulatory Flexibility Act of 1980 (RFA) \38\ generally
requires a description and analysis of proposed rules that will have
significant economic impact on a substantial number of small entities.
The RFA mandates consideration of regulatory alternatives that
accomplish the stated objectives of a proposed rule and that minimize
any significant economic impact on a substantial number of small
entities. The Small Business Administration's (SBA's) Office of Size
Standards develops the numerical definition of a small business.\39\
The SBA recently revised its size standard for electric utilities
(effective January 22, 2014) to a standard based on the number of
employees, including affiliates (from a standard based on megawatt
hours).\40\ Under SBA's new size standards, generator owners,
distribution providers, and transmission owners likely come under one
of the following categories and associated size thresholds: \41\
---------------------------------------------------------------------------

    \38\ 5 U.S.C. 601-612 (2012).
    \39\ 13 CFR 121.101 (2013).
    \40\ SBA Final Rule on ``Small Business Size Standards:
Utilities,'' 78 FR 77343 (12/23/2013).
    \41\ 13 CFR 121.201, Sector 22, Utilities.
---------------------------------------------------------------------------

     Hydroelectric power generation, at 500 employees.
     Fossil fuel electric power generation, at 750 employees.
     Nuclear power generation, at 750 employees.
     Other electric power generation (e.g. solar, wind,
geothermal, and others), at 250 employees.
     Electric bulk power transmission and control, at 500
employees.
     Electric power distribution, at 1,000 employees.
    25. Based on U.S. economic census data,\42\ the approximate
percentages of small firms in these categories varies from 24 percent
to 94 percent. However, currently FERC does not have information on how
the economic census data compares with entities registered with NERC
and is unable to estimate the number of small GOs, DPs, and TOs using
the new SBA definitions.\43\ Regardless, FERC recognizes that the rule
will likely impact small GOs, DPs, and TOs and estimates the economic
impact on each entity below.
---------------------------------------------------------------------------

    \42\ Data and further information are available from SBA
available at http://www.sba.gov/advocacy/849/12162.
    \43\ Using the previous SBA definition, 230 of the 1,019
entities affected by the proposed PRC-025-1 would have qualified as
small entities.
---------------------------------------------------------------------------

    26. Proposed Reliability Standard PRC-025-1 will serve to enhance
reliability by imposing mandatory requirements governing generator
relay loadability, thereby reducing the likelihood of premature or
unnecessary tripping of generators during system disturbances. The
Commission estimates that each of the small entities to whom the
proposed Reliability Standard PRC-025-1 applies will incur one-time
compliance costs of $4,480 (i.e., the cost of re-setting any relays
found to be out of compliance),\44\ plus paperwork and record retention
costs of $1,192 (one-time implementation) and $57.90 (annual
ongoing).\45\ Per entity, the total one-time implementation costs are
estimated to be $5,672 (including paperwork and non-paperwork costs)
and the annual ongoing costs are estimated to be $57.90.
---------------------------------------------------------------------------

    \44\ These are non-paperwork related costs, which are not
reflected in the burden described in the Information Collection
Section above, and instead reflect the burden of re-setting relays
in order to comply with the new requirements of PRC-025-1.
Specifically, this figure reflects an estimated time of 8 hours per
relay, assuming an average of 8 digital relays which will need to be
re-set per small entity, at a cost of $70 per hour (the average of
the salary plus benefits for a manager and an engineer, from Bureau
of Labor and Statistics available at http://bls.gov/oes/current/naics3_221000.htm and http://www.bls.gov/news.release/ecec.nr0.htm).
    \45\ The one-time paperwork-related implementation cost estimate
is based on a burden of 20 hours at $59.62/hour, and the annual
record-keeping cost estimate is based on a burden of 2 hours at
$28.95/hour. See supra at 21 and P 1 note/39.
---------------------------------------------------------------------------

    27. The Commission does not consider the estimated costs per small
entity to have a significant economic impact on a substantial number of
small entities. Accordingly, the Commission certifies that this NOPR
will not have a significant economic impact on a substantial number of
small entities.

V. Environmental Analysis

    28. The Commission is required to prepare an Environmental
Assessment or an Environmental Impact Statement for any action that may
have a significant adverse effect on the human environment.\46\ The
Commission has categorically excluded certain actions from this
requirement as not having a significant effect on the human
environment. Included in the exclusion are rules that are clarifying,
corrective, or procedural or that do not substantially change the
effect of the regulations being amended.\47\ The actions proposed
herein fall within this categorical exclusion in the Commission's
regulations.
---------------------------------------------------------------------------

    \46\ Regulations Implementing the National Environmental Policy
Act of 1969, Order No. 486, FERC Stats. & Regs. ] 30,783 (1987).
    \47\ 18 CFR 380.4(a)(2)(ii).
---------------------------------------------------------------------------

VI. Comment Procedures

    29. The Commission invites interested persons to submit comments on
the matters and issues proposed in this notice to be adopted, including
any related matters or alternative proposals that commenters may wish
to discuss. Comments are due April 28, 2014. Comments must refer to
Docket Nos. RM13-19-000 and RM14-3-000, and must include the
commenter's name, the organization they represent, if applicable, and
address.
    30. The Commission encourages comments to be filed electronically
via the eFiling link on the Commission's Web site at http://www.ferc.gov. The Commission accepts most standard word processing
formats. Documents created electronically using word processing
software should be filed in native applications or print-to-PDF format
and not in a scanned format. Commenters filing electronically do not
need to make a paper filing.

    31. Commenters that are not able to file comments electronically
must send an original of their comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    32. All comments will be placed in the Commission's public files
and may be viewed, printed, or downloaded remotely as described in the
Document Availability section below. Commenters on this proposal are
not required to serve copies of their comments on other commenters.

VII. Document Availability

    33. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
Internet through the Commission's Home Page (http://www.ferc.gov) and
in the Commission's Public Reference Room during normal business hours
(8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE., Room 2A,
Washington, DC 20426.
    34. From the Commission's Home Page on the Internet, this
information is available on eLibrary. The full text of this document is
available on eLibrary in PDF and Microsoft Word format for viewing,
printing, and/or downloading. To access this document in eLibrary, type
the docket number excluding the last three digits of this document in
the docket number field.
    35. User assistance is available for eLibrary and the Commission's
Web site during normal business hours from the Commission's Online
Support at<PHONE_NUMBER> (toll free at 1-866-208-3676) or email at
<EMAIL_ADDRESS>or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. Email the Public Reference Room at
<EMAIL_ADDRESS>
    By direction of the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-06591 Filed 3-26-14; 8:45 am]
BILLING CODE 6717-01-P


Gas station test/component pricing

Perkins, Rick
 to:
 Lynn Dail
                                                            05/04/2011 11:17 AM

Cc:
 "Hagan, Fred D"

Dail,
Sorry for the delay but below is a price list of Stage II versus conventional gasoline station parts.  These are approximate prices from various sources.  Maine stations follow CARB requirements such as annual pressure decay and A/L testing for most with blockage required every five years (unless retesting is triggered).  I believe you have product drop tube prices so they are not included here.  Contact either Fred Hagan<PHONE_NUMBER>) or me with any questions.  Good luck and looking forward to EPA's final decision on ST-30 (1994) versus TP-201.3.

Rick Perkins
Maine DEP, Bureau of Air Quality
312 Canco Road
Portland, Maine 04103
(207) 822-6355 (p)
(207) 822-6303 (f)
<EMAIL_ADDRESS>

Stage II Testing- Larger Station (more than 6 dispensers):
   * Flat rate of about $900 to include (PD, TIE, P/V, BLK, A/L).

Stage II Testing- Smaller Station (6 dispensers or less):
   * Flat rate of about $750 to include (PD, TIE, P/V, BLK, A/L).

Individual Cost/Breakdown of Stage II Tests:
   * PD= $350
   * TIE= $50
   * P/V= $75
   * BLK= $275
   * A/L= $350

Cost of Stage II Equipment (this would not include labor which averages about $70/hour):
   * Vac Assist Nozzle= $235
   * Balance Nozzle= $200
   * Breakaway= $125
   * 12" Whip Hose= $60
   * 8' Hose= $185
   * Flow restrictor= $75
   * Swivel Fill Adapter= $185
   * Swivel Vapor Adapter= $230
   * Plastic Fill Cap= $30
   * Plastic Vapor Cap= $32
   * Low Profile Fill Cap= $65
   * Low Profile Vapor Cap= $62
   * Standard 4" brass fill adapter= $45
   * Standard 4" Aluminum Vapor Adapter= $85
   * P/V Vent Cap= $110
   * Vac Motor= $430 (plus $179 core charge)

Conventional Dispenser Equipment Costs
   * Nozzle= $52
   * Hose (10')= $41
   * Breakaway= $28
   * Breakaway hose (8")= $15.00


[Federal Register: January 23, 2008 (Volume 73, Number 15)]
[Notices]
[Page 3967-3968]
[DOCID:fr23ja08-44]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2005-0044; FRL-8098-9]

National Lead Laboratory Accreditation Program (NLLAP); Notice of
Availability of Revisions to the NLLAP; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the availability of the revised EPA
National Lead Laboratory Accreditation Program (NLLAP) in the document
titled ``Laboratory Quality System Requirements (LQSR) Revision 3.0''
dated July 5, 2007. Revisions to the LQSR include the expansion of
NLLAP to cover: (1) Lead laboratory analysis programs that conduct lead
analysis for the field (Field Sampling and Measurement Organizations),
and (2) revised training requirements for laboratory personnel. The
Agency will phase-in LQSR 3.0 over the next 18 months.

DATES: LQSR 3.0 will become effective July 23, 2009. In order to be
recognized by the NLLAP, laboratories and accreditation organizations
that currently administer the NLLAP may comply with the requirements of
the LQSR 2.0 dated August 1, 1996, or LQSR 3.0 dated July 5, 2007.
After, July 23, 2009 all NLLAP recognized organizations must implement
and comply with the requirements of LQSR 3.0.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
    For technical information contact: Benjamin Lim, National Program
Chemicals Division (7404T), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You might potentially be affected by this action if you are or may
be required to follow the Agency's regulations regarding testing for
lead. Specifically, entities potentially affected by these revisions
are Fixed-Site, Mobile, and Field Sampling and Measurement
Organizations (FSMOs) that perform lead testing. Analytical testing
laboratories currently recognized by the NLLAP, and accreditation
organizations that currently administer the NLLAP (i.e., the American
Industrial Hygiene Association (AIHA) and the American Association for
Laboratory Accreditation (A2LA)) or other organizations that might seek
a Memorandum of Understanding (MOU) with the Agency to become an
accreditation organization could be affected by today's revisions. In
addition, certified inspectors, certified risk assessors, developers,
manufacturers, distributors of equipment and supplies used by FSMOs
testing lead might also be affected by these revisions; and EPA-
authorized state and tribal lead-based paint training and certification
programs may also be affected by these revisions.
    Other entities potentially affected by changes to the NLLAP for
lead testing are the owners and managers of target housing and child-
occupied facilities, as well as realtors, lessees, and residents, who
ultimately pay for the testing services and stand to benefit by
obtaining lead test results quicker.
    Since other entities may also be interested, the Agency has not
attempted to describe all of the specific entities that may be affected
by this notice. If you have any questions regarding the applicability
of this notice to a particular entity, consult the technical person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. Materials cited in this notice are available in docket
number EPA-HQ-OPPT-2005-0044. All documents in the docket are listed in
the regulations.gov index. To access the electronic docket, go to

http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in

hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. The telephone number of the EPA/DC Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. You may also access this

document at the Office of Pollution Prevention and Toxics Lead Home
Page at http://www.epa.gov/lead/new.htm.

II. Background

    Under the Congressional mandate stated in section 405(b) of Title
X, The Residential Lead-Based Paint Hazard Reduction Act of 1992, EPA
has established the NLLAP. The program has been established by EPA in
order to assure the public that analytical laboratories recognized by
the EPA NLLAP have demonstrated they are capable of analyzing for lead
in paint chip, dust, and/or soil samples. A list of EPA recognized lead
laboratories is updated on a periodic basis and is available from the
National Lead Information Center Clearinghouse upon request (1-800-424-
LEAD) or at the Office of Pollution Prevention and Toxics Lead Home
Page at http://www.epa.gov/lead/pubs/nllap.htm.

    The Agency is announcing changes to NLLAP to encourage the
recognition of all lead testing service providers (e.g., FSMOs) and to
bring the NLLAP into compliance with current consensus standards (e.g.,
American Society for Testing and Materials (ASTM), American National
Standards Institute (ANSI), and International Organization for
Standardization (ISO)). This may, in turn, increase lead testing
options, reduce costs, and save time for those who purchase analytical
services related to lead hazard identification and control.

III. What Action is the Agency Taking?

    The Agency made these revisions to the NLLAP to provide a vehicle
and remove barriers so that all types of lead testing service providers
could participate in the NLLAP. These changes also provide the tools
for smaller lead testing organizations to obtain NLLAP recognition.
Also these revisions are making the NLLAP more efficient and cost-
effective while maintaining the high standard of quality, science and
technology necessary to ensure public health protection in supporting
EPA and U.S. Department of Housing and Urban Development (HUD) lead
regulations.

List of Subjects

    Environmental protection, Lead testing accreditation, National Lead
Laboratory Accreditation Program (NLLAP), Laboratory Quality System
Requirements (LQSR).

    Dated: January 16, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E8-1110 Filed 1-22-08; 8:45 am]

BILLING CODE 6560-50-S


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