[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Rules and Regulations]
[Pages 47141-47146]
[FR Doc No: 2019-19370]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 10

[Docket No. USCG-2018-0041]

COMDTINST M16721.48 Merchant Mariner Medical Manual

AGENCY: Coast Guard, DHS.

ACTION: Notification of availability.

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

SUMMARY: The Coast Guard announces the availability of the Merchant
Mariner Medical Manual, Commandant Instruction Manual (COMDTINST
M16721.48). The guidance in this Manual should assist medical
practitioners, the maritime industry, individual mariners, and Coast
Guard personnel in evaluating a mariner applicant's physical and
medical status to meet the requirements of the merchant mariner medical
certificate. This Manual incorporates and consolidates prior guidance
on the medical evaluation of merchant mariners contained in several
Coast Guard documents. The Manual includes guidance on the medical
certificate and related processes, including procedures for
application, issuance, and cancellation of the medical certificate.

DATES: The Merchant Mariner Medical Manual, COMDTINST M16721.4, is
effective on September 9, 2019.

FOR FURTHER INFORMATION CONTACT: For information about this document or
to suggest changes, call or email Adrienne Buggs, M.D., United States
Coast Guard, Office of Merchant Mariner

Credentialing; telephone:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Viewing Documents

    The Merchant Mariner Medical Manual, COMDTINST M16721.4, is
available on the internet at: https://www.dcms.uscg.mil/Our-Organization/Assistant-Commandant-for-C4IT-CG-6/The-Office-of-Information-Management-CG-61/About-CG-Directives-System/ and on
CGPortal at: https://cgportal2.uscg.mil/library/directives/SitePages/Home.aspx. A link to the document will also be located on the National
Maritime Center (NMC) site: https://www.dco.uscg.mil/Our-Organization/Assistant-Commandant-for-Prevention-Policy-CG-5P/National-Maritime-Center/.

Background and Discussion of the Merchant Mariner Medical Manual

    Coast Guard regulations contained in 46 CFR part 10, subpart C,
provide the medical and physical standards that merchant mariner
applicants must meet prior to being issued a merchant mariner medical
certificate. The Merchant Mariner Medical Manual provides guidance to
the regulated community on how to comply with the regulations
pertaining to medical and physical qualifications for merchant
mariners.
    Previously, the Coast Guard provided guidance on the medical and
physical requirements for merchant mariners in the Medical and Physical
Evaluation Guidelines for Merchant Mariner Credentials, Navigation and
Inspection Circular (NVIC) 04-08, Commandant Publication (COMDTPUB)
16700.4; in the Guidance on the Issuance of Medical Certificates (NVIC
01-14); and in Part A of the Marine Safety Manual, Volume III, Marine
Industry Personnel, COMDTINST M16000.8 (Series) [MSM]. The Merchant
Mariner Medical Manual revises, updates and combines the medical
evaluation guidance previously published in NVIC 04-08, Part A of the
MSM, Volume III, and NVIC 01-14. The Coast Guard developed the draft
Manual in consultation with experienced maritime community medical
practitioners and industry stakeholders serving on the Merchant Mariner
Medical Advisory Committee (MEDMAC) and the Merchant Marine Personnel
Advisory Committee (MERPAC). The Manual reflects a synthesis of their
recommendations and the medical requirements of title 46 Code of
Federal Regulations (CFR) part 10, subpart C.
    Members of the public participated in the development of medical
policy by providing comment and serving on working groups at the public
meetings of MEDMAC and MERPAC. Additionally, the public had the
opportunity to comment on drafts of policies contained in this Manual,
and its predecessor, NVIC 04-08. See requests for comment on proposed
policies regarding: Diabetes, cardiomyopathy, and sleep disorders (80
FR 8586, Feb. 18, 2015); Medications (80 FR 4582, Jan. 28, 2015);
Seizures (78 FR 17917, Mar. 25, 2013); and Implantable cardioverter
defibrillators (77 FR 55174, Sep. 7, 2012). The Coast Guard considered
these public comments when developing this Manual.

Public Comments on the Draft Merchant Mariner Medical Manual:

    The Coast Guard published a draft of the Merchant Mariner Medical
Manual in the Federal Register and sought input from the public on the
draft (83 FR 56272, Nov. 13, 2018). The current version of the Manual
includes revisions made to address comments received in response to the
Federal Register notification. While the Coast Guard is not required to
seek or respond to public comments prior to publication of a policy
document, we chose to do so in this case because of the perceived
complexity of the Merchant Mariner Medical Manual, and because doing so
provides us the opportunity to (1) create a guidance document that is
more viable and responsive to the needs of the impacted community; and
(2) to identify and clarify remaining areas of confusion and concern
amongst the regulated community.
    The Coast Guard's notification sought general comments on the draft
Medical Manual, with emphasis on suggestions to improve readability,
clarity, and ease of use; and comments on whether the draft Manual's
proposed medical certificate cancellation policy adequately addresses
safety concerns in situations where the Coast Guard receives
information indicating that a medical certificate holder has developed
a medical condition that poses a significant risk of sudden
incapacitation, or is taking a medication that poses a significant risk
of impairment. The Coast Guard received 37 comment letters in response.

General Comments

    Ten comment letters provided a general opinion of the draft Manual,
with the majority expressing an overall positive opinion. These
commenters found the guidance in the Manual to be thorough,
straightforward and easy to use, and they found that it answered many
questions that had arisen with previous medical policy documents. The
favorable commenters appreciated that the document provides medical
evaluators, mariners and medical providers with needed and relevant
information that will reduce the need for ``back and forth'' between
the mariner and the National Maritime Center. They also found it
helpful that the Manual outlines the Coast Guard's general concerns
with particular medical conditions and discusses the general factors
that the Coast Guard will use to evaluate the medical condition and
make a fitness determination. Comments provided by the National
Transportation Safety Board (NTSB) found that the draft Medical Manual
aptly streamlines the medical certification guidance and provides a
level of detail that should assist medical personnel during the mariner
medical certification exams. The NTSB comment letter also provided the
following observations:

    The combination of the Coast Guard's increased oversight of
medical certification and development of medical guidance appears to
be highly effective at addressing safety concerns regarding medical
conditions that pose a significant risk of sudden incapacitation.
Since 2009, the NTSB has not found any medical conditions to have
contributed to the probable cause of a marine accident. However, the
NTSB continues to find effects from impairing substances (alcohol
and over-the-counter, prescription, or illicit drugs) to have
contributed to the probable cause across all modes of
transportation.

    One comment letter expressed a generally negative opinion of the
draft Medical Manual. This commenter expressed concerns that the
guidance in the Medical Manual would sacrifice maritime safety unless
the Coast Guard provided further clarification and a plan for
implementation. Additionally, the commenter opined that the guidance
does not adequately ensure that medical conditions are sufficiently
controlled for those mariners at higher risk, because the Medical
Manual does not establish clear standards for specific medical
conditions. The Coast Guard does strive to increase clarity with
publication of the Medical Manual, however, the Coast Guard disagrees
that improved clarity requires publication of an implementation plan.
Discussion of the Coast Guard's internal implementation plans are
beyond the scope of the Medical Manual. Moreover, the majority of the
policy contained in the mariner medical manual is not new guidance. It
is the same guidance, explained in greater detail, that was already
implemented in the years following the

publication of NVIC 04-08. The Coast Guard also disagrees with the
assertion that the Medical Manual should establish condition-specific
medical standards. The medical and physical standards for merchant
mariner medical certification have already been established in 46 CFR
part 10, subpart C. Establishing new medical standards is beyond the
scope of a policy document.

Ease of Use and Clarity

    A letter from another commenter requested that the Coast Guard add
an appendix that puts common conditions in a table format for quick
reference, similar to that used in the International Maritime
Organization's (IMO) Guidelines on the Medical Examination of
Seafarers. The Coast Guard disagrees on the basis that a quick
reference table would not adequately capture the discussion,
explanation and rationale that mariners, treating providers and medical
examiners need to understand in order to provide quality examinations
to the Coast Guard.

Requirements for Medical Certification

    Three comment letters recommended that the Medical Manual provide
additional medical requirements for medical certification. One letter
commented that the Medical Manual should require all mariners to meet
the same medical standard, and should provide ``specific acceptable
parameters'' for many conditions to include BMI, pulmonary function,
glucose levels, blood pressure, and cardiac function. Another comment
letter suggested that the Coast Guard should implement a random medical
testing program, similar to that used for drug testing. The third
comment letter stated that the physical ability requirements should
also include criteria for the speed and facility with which a mariner
performs required tasks. The Coast Guard disagrees with these comments.
While some of the recommendations pertaining to medical standards may
warrant future discussion, changes or additions to the medical and
physical requirements for medical certification are beyond the scope of
this document. As discussed earlier, the medical and physical standards
for medical certification are provided in 46 CFR part 10, subpart C,
and changes to those requirements would require a rulemaking.

Guidance on the Conduct of the General Medical Examination

    One comment letter addressed the guidance pertaining to the general
medical examination and recommended that the mariner medical
examination include an evaluation of the mariner's oral/dental health
condition to ensure that there are no untreated infections or other
dental problems that could cause significant impairment while at sea.
The Coast Guard agrees that such guidance may prove helpful and will
work with MEDMAC to consider whether and what type of guidance would be
appropriate for inclusion in a future version of the Medical Manual.

Frequency of Required Medical Examinations

    Four comments letters addressed the frequency of required medical
examinations. Three commenters opined that it is excessive to require
mariners to undergo a medical examination every two years. They
recommended that the medical examination for all mariners, including
those sailing under the authority of their Standards of Training,
Certification, and Watchkeeping (STCW) endorsement, should remain valid
for a period of 5 years, unless the mariner's medical condition
warrants issuance of a shorter-duration medical certificate. A
different commenter requested clarity on how often a mariner is
required to obtain a medical exam, noting that in some instances
maritime employers require an annual medical examination, even when the
Coast Guard does not.
    The Merchant Mariner Medical Manual provides detailed discussion of
medical examination and medical certification requirements for specific
endorsements, and cites the corresponding regulatory references. It is
important to note that the medical certificate validity period and the
frequency of required medical examinations may differ between
endorsements because of the differing legal requirements. Since these
requirements are established in regulation, changing them would require
a rulemaking and is beyond the scope of this policy document. The
medical examination requirements of individual employers are also
outside the scope of this policy document.

Medical Exam Forms

    One comment letter requested that the Medical Manual provide a list
of medical examination forms that would be acceptable in place of the
Form CG-719K or KE. The Coast Guard disagrees and did not provide a
list of alternative forms because 46 CFR 10.302(a) requires the
following: ``to qualify for a medical certificate, a mariner must
provide evidence of meeting the medical and physical standards . . . on
a CG-719-K or CG-719-K/E, as appropriate.''

Medical Examiners

    Ten comment letters provided comments on the topic of medical
examiners. Three commenters requested additional information on the
Designated Medical Examiner (DME) program, with one requesting that the
Coast Guard publish its timeline and intent to create the DME program.
The Coast Guard understands that there is significant interest in the
DME program and will publish additional information, as and when
appropriate.
    Five commenters recommended changes to the regulations regarding
individuals who may perform examinations for purposes of the mariner
medical certification examination. The Coast Guard considered each of
these recommendations, but noted that changes to the regulations are
beyond the scope of this policy document.

Internal National Maritime Center Processes

    Two comment letters requested that the Manual provide more detail
on internal National Maritime Center (NMC) processes. One of these
comments expressed concern that the Manual's instructions would allow
non-medical personnel to make medical determinations for U.S.
mariners.'' This commenter recommended that the Coast Guard add
language to specify that all medical certification decisions will be
supervised by a licensed medical officer. The second comment noted that
the Manual does not contain ``any reassurance or check and balance of
examiners, examination quality, or the NMC medical certification
process.'' This commenter requested that the Coast Guard add language
to address these concerns. The Coast Guard considered both of the
comments, but does not concur with them. The staffing and internal
quality assurance practices of the NMC are beyond the scope of this
document. Nonetheless, the Coast Guard affirms that the activities of
the NMC Medical Evaluations Division, particularly those related to
medical certification, are supervised by a licensed medical officer. On
the issue of providing quality assurance for medical examiners, it is
important to recognize that medical examiners are not regulated by the
Coast Guard. Therefore, providing reassurance or checks and balances of
examiners and their exam quality, is inappropriate and is beyond the
scope of this document.

Positive Drug Tests

    Two comment letters complained that the Manual does not provide
guidance

for the evaluation of mariners who test positive for illegal drug use.
One also requested that the Coast Guard add language to the Medical
Manual requiring medical treatment for any mariner who fails a USCG
required drug test. The Coast Guard does not concur with these
commenters. The Medical Manual does not address requirements related to
positive drug tests because the regulations and guidance on the
management and disposition of individuals who have a positive drug test
are contained in 46 CFR parts 5, 10, and 16. Changes to the DOT and
Coast Guard drug testing regulation and policy are beyond the scope of
this policy document. The Medical Manual contains guidance on how the
Coast Guard will conduct the medical certification evaluation for
individuals who have been diagnosed with a substance abuse disorder.
The Medical Manual does not, however, direct treatment nor provide
diagnostic instruction, because such areas are beyond the scope this
policy document.

Reporting Material Changes in Medical Condition for Mariners

    One commenter asked whether a mariner who holds a medical waiver is
required to report a material change in their medical condition. The
Coast Guard notes that the answer to this question will depend on the
provisions outlined in the mariner's medical waiver letter. Some waiver
letters require that the mariner report changes in medical condition to
the Coast Guard within a specified period of time. If no such provision
is provided in the mariner's waiver letter, then the mariner is not
required to disclose the change in medical condition until the time of
the next medical certificate application.
    Three commenters asked whether employers have an obligation to
report to the Coast Guard information regarding a change in condition.
One of these same commenters also asked how employees could protect
themselves from inaccurate reports. The Coast Guard considered each of
these comments and advises that this manual does not impose any new
reporting requirements on anyone. In response to the concerns about how
mariners will be able to protect themselves from inaccurate reports,
the Coast Guard offers that the Merchant Mariner Medical Manual only
proposes to take action on medical information that the Coast Guard has
determined as credible. The information that the Coast Guard would deem
credible differs depending upon the circumstances, but generally will
include medical provider documentation, formal incident reports,
emergency medical services reports, and investigative reports. The
Coast Guard also asserts that mariners will be able to protect
themselves from inaccurate reports because this manual provides a
standard process for evaluating these reports and further provides
mariners with notice of, and the opportunity to respond to, information
that indicates that they are no longer fit for medical certification.

Medications

    Two comment letters noticed discrepancies in the language in
Chapter 7 related to required disclosures of over-the-counter (OTC)
medications. One of the commenters also observed that the guidance in
the Manual highlighted an error on the most recent version of the
Application for Medical Certificate (Form CG-719K, Rev 04/17, Exp. Date
03/31/2021) which incorrectly states that applicants must disclose all
OTC medications taken within 30 days prior to the date the applicant
signs the CG-719K. Both commenters noted that prior versions of the CG-
719K and the Medical Manual only instructed mariners to disclose OTC
medications if the medications were used for a period of 30 days or
more within the 90 days prior to the date the applicant signs the
application to the Coast Guard. They requested that the Coast Guard
provide additional language in the Medical Manual to clarify that
applicants need only disclose OTC medications, when such medications
were used for a period of 30 days or more within the 90 days prior to
the date the applicant signs the application to the Coast Guard. The
Coast Guard agrees that the language change regarding OTC medication
disclosures on the most recent version of the CG-719K was an
inadvertent change, and language was added to Chapter 7 of the Medical
Manual to clarify the reporting requirements for OTC medications. The
Coast Guard will be pursuing a change to CG-719K in the future to
correct this change.
    Attendant with the language change regarding OTC medications, the
Coast Guard also considered the NTSB's comments about impairing
medication effects that have contributed to the probable cause of
accidents across all modes of transportation. In light of these
concerns, the Coast Guard determined that it would be prudent to add
additional guidance regarding OTC medications to the Important Safety
Warnings paragraph of Chapter 7. Specifically, the additional guidance
warns that some OTC medications and preparations may contain
intoxicants or other dangerous drugs prohibited by Department of
Transportation regulations.

NMC Medical Evaluation Procedures for Mariners With Existing Waivers

    One commenter expressed confusion over the discussion of the term
clear error in Paragraph I.3. of Chapter 3 of the Medical Manual.
Paragraph I discusses NMC medical evaluation procedures for mariners
with existing waivers, and Paragraph I.3. states that the Coast Guard
is not bound to honor a medical waiver that was issued in clear error,
contrary to duly promulgated policy in effect at time of issuance. The
commenter mistakenly interpreted the clear error discussion to mean
that the Coast Guard would not take responsibility for any erroneous
certification decisions that might lead to mishaps or untoward medical
situations at sea. In order to clear up this area of confusion, the
Coast Guard added language to Paragraph I.3. of Chapter 3, to clarify
that the discussion of clear error pertains to medical waivers that
were issued in error.

Alternative Testing Methodologies for Color Vision

    One comment letter asserted that the discussion of alternative
testing methodologies for demonstrating satisfactory color vision
contained Paragraph A.1.d.(2)(c) contains an error because it indicates
that the Farnsworth D-15 may be used as a potential alternative color
vision test for Deck personnel. The Coast Guard disagrees. Title 46 CFR
10.305(a) provides that mariners must demonstrate satisfactory color
sense through one of the tests listed in the regulation, or through an
alternative test acceptable to the Coast Guard. Paragraph A.1.d.(2) of
the Medical Manual provides guidance for mariner applicants seeking to
demonstrate satisfactory color vision sense through use of an
alternative test, and describes the type of information that the Coast
Guard will consider in determining whether an alternative test is
sufficient for issuance of the medical certificate. The guidance does
not guarantee that any singular test will be accepted as an alternative
methodology for any particular mariner applicant, but rather states
that the Coast Guard retains final authority for determining whether
the testing is acceptable, and recommends that any alternative test be
accompanied by a formal color vision evaluation from an ophthalmologist
or optometrist.

Coast Guard Mission and Motives With Respect to Medical Credentialing

    One commenter asserted that the Coast Guard should ``consider its
mission and motives with respect to medical credentialing,'' and
expressed displeasure that the Medical Manual focuses on ``medical
credentialing without making any decisions on mariner fitness for
duty.'' The Coast Guard considered this commenter's concerns and noted
that the Medical Manual's purpose, as stated in Paragraph 1 of the
Letter of Promulgation for the Merchant Mariner Medical Manual, is to
``provide guidance for evaluating the physical and medical condition of
applicants for merchant mariner medical certificates.'' The Coast Guard
also notes that making a determination of fitness for certification is
distinctly different from making a determination of fitness for duty,
and refers the reader to the discussion that follows.
    Fitness-for-certification. The medical and physical standards for
merchant mariner medical certification are contained in 46 CFR part 10,
subpart C. The Coast Guard mariner medical evaluation and certification
process seeks to determine whether an applicant meets the medical and
physical standards for merchant mariners based upon the information
available to the Coast Guard at the time of the certification decision.
In accordance with 46 CFR 10.301, the Coast Guard will issue a medical
certificate to a mariner meeting the medical and physical standards for
merchant mariners. This decision is necessarily a snapshot of the
mariner's medical and physical condition at a single point in time.
    Fitness-for-duty. In general, fitness for duty refers to an
employee's ability to perform his/her essential job functions, as
specified by the employer, without impairment from medical conditions
or medications. There are some important considerations with respect to
fitness for duty. First, an individual's fitness-for-duty status is not
static, thus it should be considered whenever an individual reports for
duty. Fitness-for-duty status can change suddenly due to an acute
illness, injury or incident. As an example, an individual with no
medical problems who has been issued a medical certificate and who
normally performs their essential job functions without impairment,
could become ``not-fit-for duty'' because of an impairing illness such
as the flu, and/or due to impairing medications used to treat an acute
illness. The second important consideration is that a ``fitness-for
duty'' determination refers to an evaluation ordered by an employer to
assess an employee's ability to perform the essential functions of
their assigned job (as specified by the employer). Such an evaluation
might be requested when the employer has a reasonable belief that an
employee will not be able to perform essential job functions because of
their medical condition. A variety of state and Federal laws govern
fitness for duty determinations depending upon the specific
circumstances. Generally, a fitness for duty physical must be job-
related and consistent with business necessity. One other important
consideration is that the merchant mariner medical qualification
standards in part 10, subpart C, are the minimum acceptable standards.
Some maritime employers may choose to establish medical and/or physical
ability requirements for their employees that are more stringent than
the Coast Guard medical certification standards based on factors such
as specific duty requirements, austere work environments, and
operational tempo. In these cases, the employer's fitness-for-duty
determinations may differ from the medical certification determination
because they are based upon different standards. The Merchant Mariner
Medical Manual does not preclude marine employers from establishing
more rigorous medical or physical ability guidelines; however, there
are additional laws and regulations that apply.

Line-by-Line List of Changes

    Two commenters requested a detailed, line-by-line list of proposed
changes that compares the current language in NVIC 04-08 with each
change, addition and deletion made in the Medical Manual. The Coast
Guard considered this comment, but determined that a line-by-line list
of changes would not be helpful because of the extensive changes in
wording, format and organization between the two documents. Instead,
the Coast Guard has already provided a fairly comprehensive discussion
of the major changes in Paragraph 6 of the Letter of Promulgation for
the Medical Manual.

Medical Certificate Cancellation

    Commenters were both supportive of, and objected to, the proposed
medical certificate cancellation policy. After considering the
comments, we decided to proceed with the proposed policy. One commenter
who opposed the policy nevertheless provided a number of suggested
edits to the text which were adopted. Those opposed to the cancellation
policy suggested the Suspension and Revocation (S&R) process (46 CFR
part 5) as an alternative. The Suspension and Revocation (S&R) process
has limited jurisdiction over mariner medical issues. On this subject,
S&R is authorized in circumstances where a credentialed mariner has
committed an act of incompetence relating to the operation of a vessel
(see 46 U.S.C. 7703(4)). A mariner having a disqualifying medical
condition is not something addressed through S&R unless and until it
has impacted vessel operation. Accordingly, the medical certificate
cancellation and waiver processes set forth in the manual effectively
address mariner medical qualification and fitness for duty concerns in
ways that the S&R system cannot. There are also situations such as
mariners using dangerous drugs or operating vessels under the influence
of alcohol or other intoxicants that present both medical qualification
and S&R concerns, so it may be appropriate for the Coast Guard to
utilize both the procedures set forth in this manual and the S&R
process to address and resolve these issues in the interest of safety.

Waivers, Limitations, Restrictions

    One commenter requested more detail on limitations and
restrictions. The commenter noted that waivers seem not to have been
consistently applied to conditions. The Coast Guard agrees in part and
over the last few years has provided further guidance on waivers for
the most frequently occurring conditions. Those changes to NVIC 04-08
have been carried forward into this manual.

Process for Removing Waivers, Limitations and Restrictions

    One commenter complained that the process for removing restrictions
and waivers ``seems uncomfortably weighted toward taking away one's
ability to sail, without considering that many conditions--even very
serious ones--are temporary in nature.'' The Coast Guard disagrees and
notes that the Medical Manual provides specific guidance on medical
evaluation procedures for mariners with short-term conditions (see
paragraph J. of Chapter 3 of the Medical Manual). These provisions were
included to reduce the burden of imposing and then removing waivers and
restrictions for conditions that are expected to resolve in the short-
term.
    This document is issued under the authority of 5 U.S.C. 552(a), 46
U.S.C. 7101, and 46 U.S.C. 7302.

    Dated: September 3, 2019.
J. G. Lantz,
Director, Commercial Regulations and Standards, U.S. Coast Guard.
[FR Doc. 2019-19370 Filed 9-6-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36509-36510]
[FR Doc No: 2022-13069]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3662]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance on Reagents
for Detection of Specific Novel Influenza A Viruses

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by July 18, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0584. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance on Reagents for Detection of Specific Novel Influenza A
Viruses--21 CFR Part 866

OMB Control Number 0910-0584--Extension

    In accordance with section 513 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360c), FDA evaluated an application
for an in vitro diagnostic device for detection of influenza subtype H5
(Asian lineage), commonly known as avian flu. FDA concluded that this
device is properly classified into class II in accordance with section
513(a)(1)(B) of the FD&C Act, because it is a device for which the
general controls by themselves are insufficient to provide reasonable
assurance of the safety and effectiveness of the device, but there is
sufficient information to establish special controls to provide such
assurance. The statute permits FDA to establish as special controls
many different things, including postmarket surveillance, development
and dissemination of guidance recommendations, and ``other appropriate
actions as the Secretary [of HHS] deems necessary'' (section
513(a)(1)(B) of the FD&C Act). This information collection is a measure
that FDA determined to be necessary to provide reasonable assurance of
safety and effectiveness of reagents for detection of specific novel
influenza A viruses.
    FDA issued an order classifying the H5 (Asian lineage) diagnostic
device into class II on March 22, 2006 (71 FR 14377), establishing the
special controls necessary to provide reasonable assurance of the
safety and effectiveness of that device and similar future devices. The
new classification was codified in 21 CFR 866.3332, a regulation that
describes the new

classification for reagents for detection of specific novel influenza A
viruses and sets forth the special controls that help to provide a
reasonable assurance of the safety and effectiveness of devices
classified under that regulation. The regulation refers to the document
entitled ``Class II Special Controls Guidance Document: Reagents for
Detection of Specific Novel Influenza A Viruses,'' which provides
recommendations for measures to help provide a reasonable assurance of
safety and effectiveness for these reagents. The guidance recommends
that sponsors obtain and analyze postmarket data to ensure the
continued reliability of their device in detecting the specific novel
influenza A virus that it is intended to detect, particularly given the
propensity for influenza viruses to mutate and the potential for
changes in disease prevalence over time. The guidance document is
available on our website at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078583.htm.
    As updated sequences for novel influenza A viruses become available
from the World Health Organization, National Institutes of Health, and
other public health entities, sponsors of reagents for detection of
specific novel influenza A viruses will collect this information,
compare them with the primer/probe sequences in their devices, and
incorporate the result of these analyses into their quality management
system, as required by 21 CFR 820.100(a)(1). These analyses will be
evaluated against the device design validation and risk analysis
required by 21 CFR 820.30(g) to determine if any design changes may be
necessary.
    In the Federal Register of January 25, 2022 (87 FR 3812), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                   TABLE 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping regarding reagents for detection of specific novel                 12                2               24               15              360
 influenza A viruses...............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an
overall increase of 330 hours and a corresponding increase of 22
records. We attribute this adjustment to an increase in the number of
devices of this type being manufactured over the last few years.

    Dated: June 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13069 Filed 6-16-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 19, 2006 (Volume 71, Number 181)]
[Notices]
[Page 54809-54810]
[DOCID:fr19se06-38]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP05-92-001; CP05-93-001; CP05-94-002]

Liberty Gas Storage LLC; Notice of Application To Amend
Certificate

September 13, 2006.
    Take notice that on September 7, 2006, Liberty Gas Storage LLC
(Liberty), 101 Ash Street, San Diego, CA 92101, filed in the above
referenced dockets, an application pursuant to section 7(c) of the
Natural Gas Act (NGA), requesting authorization to amend its
certificate of public convenience and necessity that was issued
pursuant to section 7 of the NGA, and its blanket certificates issued
pursuant to 18 CFR Parts 157 and 284, all as more fully set forth in
the application which is on file with the Commission and open to public
inspection. The filing may also be viewed on the web at http://www.ferc.gov
 using the ``eLibrary'' link. Enter the docket number

excluding the last three digits in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,

contact<PHONE_NUMBER>.
    Specifically, Liberty requests authorization from the Commission to
enter into a transaction necessary for Liberty to receive a real
property tax exemption with respect to the pipeline, compression and
appurtenant facilities in Calcasieu Parish, Louisiana that have been
authorized by the Commission. The transaction will consist of the
transfer of legal title to such facilities to a local governmental
agency, the Industrial Development Board of Calcasieu Parish, Louisiana
(Development Board). The Development Board will, upon transfer of
title, lease the facilities back to Liberty. Liberty

will thus retain operational control of, and responsibility for, the
facilities. Liberty asserts that the transaction will have no effect on
the natural gas storage and other services that Liberty will provide to
its customers. Upon termination of the lease, Liberty will reacquire
title to the facilities.
    Any questions regarding Liberty Gas Storage, LLC's application
should be directed to: William D. Rapp, Senior Regulatory Counsel,
Sempra Energy, 101 Ash Street, HQ 13, San Diego, CA 92101, phone: (619)
699-5050, e-mail<EMAIL_ADDRESS>or to: Stacy Van Goor, Director,
Federal Energy Regulatory Affairs, Sempra Global, 101 Ash Street, HQ 8,
San Diego, CA 92101, phone<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date, file with the Federal Energy Regulatory
Commission, 888 First Street, NE, Washington, DC 20426, a motion to
intervene in accordance with the requirements of the Commission's Rules
of Practice and Procedure (18 CFR 385.214 or 385.211) and the
Regulations under the NGA (18 CFR 157.10). A person obtaining party
status will be placed on the service list maintained by the Secretary
of the Commission and will receive copies of all documents filed by the
applicant and by all other parties. A party must submit 14 copies of
filings made with the Commission and must mail a copy to the applicant
and to every other party in the proceeding. Only parties to the
proceeding can ask for court review of Commission orders in the
proceeding.
    Persons who wish to comment only on the environmental review of
this project, or in support of or in opposition to this project, should
submit an original and two copies of their comments to the Secretary of
the Commission. Environmental commenters will be placed on the
Commission's environmental mailing list, will receive copies of the
environmental documents, and will be notified of meetings associated
with the Commission's environmental review process. Environmental
commenters will not be required to serve copies of filed documents on
all other parties. The Commission's rules require that persons filing
comments in opposition to the project provide copies of their protests
only to the applicant. However, the non-party commenters will not
receive copies of all documents filed by other parties or issued by the
Commission (except for the mailing of environmental documents issued by
the Commission) and will not have the right to seek court review of the
Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

    Comment Date: October 4, 2006

Magalie R. Salas,
 Secretary.
[FR Doc. E6-15525 Filed 9-18-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Page 50586]
[FR Doc No: 2021-19557]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT: 86 FR 50201,
September 7, 2021.

PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING: Thursday, September
9, 2021 at 2:00 p.m.

CHANGES IN THE MEETING: The Closed Meeting scheduled for Thursday,
September 9, 2021 at 2:00 p.m., has been changed to Thursday, September
9, 2021 at 3:00 p.m.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: September 7, 2021.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2021-19557 Filed 9-7-21; 4:15 pm]
BILLING CODE 8011-01-P


              EPA Meeting with Fiberglass Tank and Pipe Institute
                               January 25, 2012

Attendees:
EPA OUST:  Mark Barolo, Liz McDermott, Linda Gerber, Tim Smith, Paul Miller, Tim Roberts, Erin Knighton, Cho Yi Kwan

FTPI:
Sully Curran, FTPI
Tom Tietjen, Xerxes Corp.
Clay Findley, Containment Solutions
Ron Shaffer, Containment Solutions
Chris Johnston, LFM Fiberglass
Joie Folkers, NOV Fiberglass Systems
Jeff Leiter, Leiter and Cramer PLLC

At this meeting EPA and the Fiberglass Tank and Pipe Institute (FTPI) discussed the proposed changes to the UST regulations.  The discussion included FTPI's comments on many of the changes, including secondary containment, continuous monitoring, operation and maintenance, compatibility and codes of practice.


[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Page 23418]
[FR Doc No: 2021-09188]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4534-DR; Docket ID FEMA-2021-0001]

Idaho; Amendment No. 4 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Idaho (FEMA-4534-DR), dated April 9, 2020, and related
determinations.

DATES: This amendment was issued March 11, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Idaho is hereby amended to include Individual
Assistance limited to COVID-19 Funeral Assistance under Other Needs
Assistance for those areas determined to have been adversely affected
by the event declared a major disaster by the President in his
declaration of April 9, 2020.

    Individual Assistance limited to COVID-19 Funeral Assistance
under Other Needs Assistance for all areas in the State of Idaho
(already designated for Individual Assistance, limited to the Crisis
Counseling Program and emergency protective measures [Category B]
not authorized under other Federal statutes, including direct
Federal assistance).

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-09188 Filed 4-30-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 9 (Tuesday, January 14, 2020)]
[Notices]
[Pages 2127-2128]
[FR Doc No: 2020-00439]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC20-29-000.
    Applicants: Northeast Energy Associates, A Limited Partnership,
North Jersey Energy Associates, A Limited Partnership, Vistra Energy
Corp., NextEra Energy, Inc.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act, et al. of Northeast Energy Associates, A Limited
Partnership, et al.
    Filed Date: 1/7/20.
    Accession Number: 20200107-5110.
    Comments Due: 5 p.m. ET 1/28/20.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER13-2100-005; ER13-2109-009; ER13-434-007; ER16-
1750-006; ER16-2601-004; ER17-2292-004; ER17-2381-003; ER19-1656-003.
    Applicants: Virginia Electric and Power Company, Dominion Energy
Generation Marketing, Inc., Fowler Ridge Wind Farm LLC, Summit Farms
Solar, LLC, Southampton Solar, LLC, Scott-II Solar LLC, Wilkinson Solar
LLC.
    Description: Notice of Non-Material Change in Status of the
Dominion Energy PJM Companies.
    Filed Date: 1/7/20.
    Accession Number: 20200107-5122.
    Comments Due: 5 p.m. ET 1/28/20.

    Docket Numbers: ER19-1501-001.
    Applicants: Appalachian Power Company, PJM Interconnection, L.L.C.

    Description: Compliance filing: PJM TOs submit revisions in
compliance with the Commission's 12/19/2019 to be effective 4/22/2016.
    Filed Date: 1/7/20.
    Accession Number: 20200107-5108.
    Comments Due: 5 p.m. ET 1/28/20.

    Docket Numbers: ER20-743-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Amended Service Agreement
Procter & Gamble Paper Products Company to be effective 1/1/2020.
    Filed Date: 1/7/20.
    Accession Number: 20200107-5099.
    Comments Due: 5 p.m. ET 1/28/20.

    Docket Numbers: ER20-744-000.
    Applicants: Actual Energy, Inc.
    Description: Baseline eTariff Filing: Market-Based Rate Tariff
Application to be effective 1/8/2020.
    Filed Date: 1/7/20.
    Accession Number: 20200107-5100.
    Comments Due: 5 p.m. ET 1/28/20.

    Docket Numbers: ER20-745-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: Calpine NITSA Rev 13 to be
effective 1/1/2020.
    Filed Date: 1/7/20.
    Accession Number: 20200107-5101.
    Comments Due: 5 p.m. ET 1/28/20.

    Docket Numbers: ER20-746-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Service Agreement No. 375
Papago LLC to be effective 12/23/2019.
    Filed Date: 1/7/20.
    Accession Number: 20200107-5102.
    Comments Due: 5 p.m. ET 1/28/20.

    Docket Numbers: ER20-747-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of Service
Agreement No. 3466, Queue No. NQ77 to be effective 3/14/2020.
    Filed Date: 1/7/20.
    Accession Number: 20200107-5103.
    Comments Due: 5 p.m. ET 1/28/20.

    Docket Numbers: ER20-748-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Service Agreement Nos. 367
and 376 to be effective 12/9/2019.
    Filed Date: 1/7/20.
    Accession Number: 20200107-5104.
    Comments Due: 5 p.m. ET 1/28/20.

    Docket Numbers: ER20-749-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEPTX-Woodward Mountain Wind
GIA 3rd Amended and Restated to be effective 12/19/2019.
    Filed Date: 1/7/20.
    Accession Number: 20200107-5106.
    Comments Due: 5 p.m. ET 1/28/20.

    Docket Numbers: ER20-750-000.
    Applicants: Dominion Energy South Carolina, Inc.
    Description: Late-Filed Borderline Agreement, et al. of Dominion
Energy South Carolina, Inc.
    Filed Date: 1/7/20.
    Accession Number: 20200107-5119.
    Comments Due: 5 p.m. ET 1/28/20.

    Docket Numbers: ER20-751-000.
    Applicants: El Paso Electric Company.
    Description: Sec.  205(d) Rate Filing: Service Agreement No. 327,
Short-Term Conditional Firm PTP Agreement with EDF to be effective 3/9/
2020.
    Filed Date: 1/8/20.
    Accession Number: 20200108-5062.
    Comments Due: 5 p.m. ET 1/29/20.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 8, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-00439 Filed 1-13-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 15, 2009 (Volume 74, Number 239)]
[Notices]
[Page 66398-66400]
[DOCID:fr15de09-112]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2009-0170]

Highway Safety Programs; Conforming Products List of Screening
Devices To Measure Alcohol in Bodily Fluids

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice.

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

SUMMARY: This Notice amends and updates the list of devices that
conform to the Model Specifications for Screening Devices to Measure
Alcohol in Bodily Fluids.

DATES: Effective Date: December 15, 2009.

FOR FURTHER INFORMATION CONTACT: Ms. De Carlo Ciccel, Behavioral
Research Division, NTI-131, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590;
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On August 2, 1994, NHTSA published Model
Specifications for Screening Devices to Measure Alcohol in Bodily
Fluids (59 FR 39382). These specifications established performance
criteria and methods for testing alcohol screening devices to measure
alcohol content. The specifications support State laws that target
youthful offenders (e.g., ``zero tolerance'' laws) and the Department
of Transportation's workplace alcohol testing program. NHTSA published
its first Conforming Products List (CPL) for screening devices on
December 2, 1994 (59 FR 61923, with corrections on December 16, 1994 in
59 FR 65128), identifying the devices that meet NHTSA's Model
Specifications for Screening Devices to Measure Alcohol in Bodily
Fluids. Five devices appeared on that first list. Thereafter, NHTSA
amended the CPL on August 15, 1995 (60 FR 42214) and on May 4, 2001 (66
FR 22639), adding 7 devices to the CPL in those two actions. On
September 19, 2005, NHTSA published an updated CPL (70 FR 54972),
adding several devices to the list and removing several other devices.
Subsequently NHTSA discovered an error regarding the name of a device
listed on the CPL and republished the CPL on December 5, 2005 (70 FR
72502) to correct the error. NHTSA last published an update to the CPL
on January 31, 2007 (72 FR 4559), adding 3 new devices.
    On March 31, 2008, NHTSA published revised Model Specifications for
Screening Devices to Measure Alcohol in Bodily Fluids (73 FR 16956).
These specifications removed testing of interpretive screening devices
(ISDs) because ISDs did not provide an unambiguous test result. These
specifications also removed from use the Breath Alcohol Sample
Simulator as it is not necessary for testing breath alcohol screening
devices. All other performance criteria and test methods were
maintained.
    Since the publication of the last CPL, NHTSA has evaluated
additional devices at the Volpe National Transportation Systems Center
(VNTSC) in Cambridge, Massachusetts, resulting in the addition of 14
new breath alcohol screening devices to the CPL. One device is being
removed from the CPL as it is no longer supported or sold by the
manufacturer and several devices are being renamed.
    (1) AK Solutions USA, LLC, submitted 3 screening devices for
testing, several trade name revisions, and the removal of 1 device from
the CPL. The trade names of the new conforming devices are: AlcoMate
AccuCell AL-9000, a handheld device with a fuel cell sensor; AlcoMate
Premium AL-7000, a handheld device that utilizes replaceable
semiconductor detectors, and AlcoMate Prestige (AL-6000), also a
handheld device that utilizes replaceable semiconductor detectors. The
replaceable detectors also conform to the model specifications and are
specific to each device. Alcoscan AL-5000 is being removed from the
list. This device is no longer being sold or supported by the
manufacturer. The following three devices are being renamed: SafeMate
(formerly known as AlcoChecker), SafeDrive (formerly known as AlcoKey),
and AlcoMate Core (formerly known as Alcoscan AL-6000). (2) BAC
Solutions, Inc., submitted a screening device for testing. The trade
name for this device is BACmaster. This is a bench top stationary
screening device with an infrared detector. (3) B.E.S.T. Labs, Inc.,
submitted a device for testing. The PB 9000e is a handheld device with
a fuel cell sensor. (4) CMI, Inc., submitted a device for testing. This
device, the Intoxilyzer 500, with a handheld fuel cell sensor conforms
to the model specification for alcohol screening devices. This is the
same device listed below as the Alcometer 500, distributed by Lion
Laboratories, Ltd. (5) First Innovative Technology Group, Ltd.,
submitted a device, the AAT198 Pro. This is a handheld device with a
semiconductor detector. (6) Guth Laboratories, Inc., submitted the
Alcotector WAT90 for testing. This conforming device is handheld with a
fuel cell sensor. (7) KHN Solutions, LLC, submitted 2 screening devices
for

testing. Their trade names are: BACTRACK Select S50 and the BACTRACK
Select S80 and both devices are handheld. The BACTRACK Select S50 has a
semiconductor detector while the S80 has a fuel cell sensor. (8) Lion
Laboratories, Ltd. submitted the Alcometer 500. This is the same device
as the Intoxilyzer 500 submitted by CMI, Inc., listed above. (9) Q3
Innovations, Inc. submitted 2 screening devices for testing. The
AlcoHAWK PT500 and the AlcoHAWK Slim 2 are handheld with semiconductor
detectors. All of the above devices meet the NHTSA Model Specifications
for Screening Devices to Measure Alcohol in Bodily Fluids.
    Consistent with paragraphs (1) and (2) above, NHTSA amends the
Conforming Products List of Screening Devices to Measure Alcohol in
Bodily Fluids to read as follows:

          Conforming Products List of Alcohol Screening Devices
------------------------------------------------------------------------
       Distributors/manufacturer                     Devices
------------------------------------------------------------------------
AK Solutions, USA, LLC., Palisades        AlcoScan AL-2500.
 Park, New Jersey.\1\.
                                          SafeMate.\2\
                                          SafeDrive.
                                          AlcoMate.\3\ (aka:
                                          AlcoHAWK Pro by Q3
                                          Innovations).
                                          AlcoMate Accu Cell AL-
                                          9000.
                                          AlcoMate Pro.\3\
                                          AlcoMate Core.\4\
                                          AlcoMate Premium AL-
                                          7000, with replaceable Premium
                                          Sensor Modules (SM-7000).4 5
                                          AlcoMate Prestige AL-
                                          6000, with replaceable
                                          Prestige Sensor Modules (SM-
                                          6000).4 6
Alco Check International, Hudsonville,   Alco Check 3000 D.O.T.\7\
 Michigan.
                                         Alco Check 9000.\7\
Akers Biosciences, Inc., Thorofare, New  Breath Alcohol [check] .02
 Jersey.                                  Detection System.\8\
BAC Solutions, Inc., Birmingham,         BACmaster.
 Michigan.
B.E.S.T. Labs., Boardman, Ohio.........  PB 9000e.
Chematics, Inc., North Webster, Indiana  ALCO-SCREEN 02 \TM\.\9\
CMI, Inc., Owensboro, Kentucky.........  Intoxilyzer 500 (aka: Alcometer
                                          500--Lion Laboratories).
First Innovative Technology Group,       AAT198--Pro.
 Ltd., Hong Kong.
Guth Laboratories, Inc., Harrisburg,      Alco Tector Mark X.
 Pennsylvania.
                                          Mark X Alcohol
                                          Checker.
                                          Alcotector WAT89EC-1.
                                          Alcotector WAT90.
Han International Co., Ltd.,\2\ Seoul,   A.B.I. (Alcohol Breath
 Korea.                                   Indicator) (aka: AlcoHAWK ABI
                                          by Q3 Innovations).
KHN Solutions, LLC, San Francisco,       BACTRACK Select S50 \10\
 California.                             BACTRACK Select S80.\10\
Lion Laboratories, Ltd., Wales, United   Alcometer 500 (aka: Intoxilyzer
 Kingdom.                                 500--CMI, Inc.).
OraSure Technologies, Inc., Bethlehem,   Q.E.D. A150 Saliva Alcohol
 Pennsylvania.                            Test.
PAS Systems International, Inc.,         PAS Vr.
 Fredericksburg, Virginia.
Q3 Innovations, Inc., Independence,       AlcoHAWK Precision.
 Iowa.
                                          AlcoHAWK Slim.
                                          AlcoHAWK Slim 2.
                                          AlcoHAWK Elite.
                                          AlcoHAWK ABI (aka:
                                          A.B.I. (Alcohol Breath
                                          Indicator) by Han Intl.).
                                          AlcoHAWK Micro.
                                          AlcoHAWK PRO (aka:
                                          AlcoMate by AK Solutions).
                                          AlcoHAWK PT 500.
Repco Marketing, Inc., Raleigh, North    Alco Tec III.
 Carolina.
Seju Engineering Co., Taejeon, Korea...  Safe-Slim.
Sound Off, Inc., Hudsonville, Michigan.  Digitox D.O.T.\7\.
Varian, Inc., Lake Forest, California..  On-Site Alcohol.\11\
------------------------------------------------------------------------
\1\ The AlcoMate was manufactured by Han International of Seoul, Korea,
  but marketed and sold in the U.S. by AK Solutions.
\2\ Manufactured by Seju Engineering, Korea.
\3\ Han International does not market or sell devices directly in the
  U.S. market. Other devices manufactured by Han International are
  listed under AK Solutions, Inc. and Q-3 Innovations, Inc.
\4\ Manufactured by Sentech Korea Corp.
\5\ These devices utilize replaceable semiconductor detectors. Instead
  of re-calibrating the device, a new calibrated detector can be
  installed. This device comes with 4 detectors including the one that
  was already installed.
\6\ These devices utilize replaceable semiconductor detectors. Instead
  of re-calibrating the device, a new calibrated detector can be
  installed. This device comes with 5 detectors including the one that
  was already installed.
\7\ While these devices are still being sold, they are no longer
  manufactured or supported.
\8\ The Breath Alcohol [check] .02 Detection System consists of a single-
  use disposable breath tube used in conjunction with an electronic
  analyzer that determines the test result. The electronic analyzer and
  the disposable breath tubes are lot specific and manufactured to
  remain calibrated throughout the shelf-life of the device. This
  screening device cannot be used after the expiration date.
\9\ While the ALCO-SCREEN 02TM saliva-alcohol screening device
  manufactured by Chematics, Inc. passed the requirements of the Model
  Specifications when tested at 40 [deg]C (104 [deg]F), the manufacturer
  has indicated that the device cannot exceed storage temperatures of 27
  [deg]C (80 [deg]F). Instructions to this effect are stated on all
  packaging accompanying the device. Accordingly, the device should not
  be stored at temperatures above 27 [deg]C (80 [deg]F). If the device
  is stored at or below 27 [deg]C (80 [deg]F) and used at higher
  temperatures (i.e., within a minute), the device meets the Model
  Specifications and the results persist for 10-15 minutes. If the
  device is stored at or below 27 [deg]C (80 [deg]F) and equilibrated at
  40 [deg]C (104 [deg]F) for an hour prior to sample application, the
  device fails to meet the Model Specifications. Storage at temperatures
  above 27 [deg]C (80 [deg]F), for even brief periods of time, may
  result in false negative readings.
\10\ Manufactured by DA Tech Co., Ltd., Korea.

\11\ While this device passed all of the requirements of the Model
  Specifications, readings should be taken only after the time specified
  by the manufacturer. For valid readings, the user should follow the
  manufacturer's instructions. Readings should be taken one (1) minute
  after a sample is introduced at or above 30 [deg]C (86 [deg]F);
  readings should be taken after two (2) minutes at 18 [deg]C-29 [deg]C
  (64.4 [deg]-84.2 [deg]F); and readings should be taken after five (5)
  minutes when testing at temperatures at or below 17 [deg]C (62.6
  [deg]F). If the reading is taken before five (5) minutes has elapsed
  under the cold conditions, the user is likely to obtain a reading that
  underestimates the actual saliva-alcohol level.

    Authority: 23 U.S.C. 403; 49 CFR 1.50; 49 CFR part 501.

    Issued on: November 18, 2009.
Jeff Michael,
Associate Administrator for the Office of Research and Program
Development.
[FR Doc. E9-29822 Filed 12-14-09; 8:45 am]

BILLING CODE 4910-59-P


ALPHA GAMMA T E C H N O L O G I E S , 1 N C . A 70 4 5  2 F B  y MEMORANDC'M DATE: March 22, 2002 i i arge Municipal SUBJECT: Summary of Equations used to Calcu i Waste Combustion Units Following MACT Retrofit ( Test Data)

FROM: Bradley Nelson Alpha Gama Technologies, Inc.

TO: ' Wait Stevenson, EPNCombustion Group The purpose of this memorandum is to present the equations used to calculate the annual pollutant emissions from large Municipal Waste Combustor ( MWC) units. This memorandum is randum titled " Emissions from Large Municipal Waste Combustion ) Following MACT Retrofit ( Year 2000 Test Data); Docket A 90 45; VIII B 3.

line the steps that were used to calculate MWC unit emissions.

to convert compliance test data into an nts, which include dioxins/ fUrans ( CDD/ CDF),

cadmium ( Cd), hydrochloric acid ( HCI), s u k r dioxide ( SO,), nitrogen oxides ( NO,), and ter ( PM). Emissions for CDDICDF were calculated in units of grams per year total mass and TEQ' basis.

ns were summed to Toxic Equivalency Quantity ( TEQ) values based on 1989 NATO Toxic Equivalency Factors. As background, the Emission Guidelines ( EG) for large MWC units under Section 129 of the Clean Air Act were adopted in 1995 ( 40 CFR part 60, subpart Cb), and required all large MWC units to be in. compliance with either a compliance test reports due by Au 167 large NWC units located ants in 24 states. From these reports, data was extracted on pollutant emission concentratio compliance test, steam rate during the compliance test, and annu as used to calculate the annual emissions for each Section 129 pollutant for each of the 167 large MFVC units. Annual waste combusted data ( tons waste cornbusted pe ratios and provide information on the total plant specific data were used except for th or a Federal Plan by December 2000, with obtained the compliance te ted and used to calculate process ted in the U. S. In all cases,

i Conversion Factors SO, Ratio  The EG requires all unit the annual emission calcu to convert SO, geometric mean units provided values for generate usable data for units of 1.12 to 1 was calculated. a geometric mean. For TEQ Ratio  All units provided CD under the Emission Guidelines. T were calculated. From the data,

and TEQ basis. A total mass/ TEQ rat units not reporting TEQ data. The to mass basis. This is required The equations used to calculate the annual emissions of the Section f29 pollutants are provided in Attachment 1. The calculation ed a three step proce C:\ SrnallMWC\ Docket\ 70802submitt~ 9~ v~~ 9. wpd 2 The compliance test pollutant emission rate ( masdtime) was calculated by multiplying the poUutant concentration ( mass/ volume) by the stack flow rate ( volume/ time) during the test.

The pollutant emission rate ( masdtime) was divided by the steam flow rate during the test ( ib steamltime) to calculate a pollutant to steam factor ( mass/ lb steam).

The pollutant to steam factor ( massfib steam) was multiplied by the annual steam output ( Ib steamlyear) to calculate the annual pollutant emission rate ( madyear).

The pollutant concentration units varies between poUutants and are as follows; ng/ dscm and HCI). All data are presented on a dry basis, corrected to 7% 0,. For NO, and SO, the fEst 24 hour CEM average was used for emission calculations. Q ( CDD/ CDF), mg/ dscm ( PM, Cd, Pb, and Hg) and ppmV ( NO,, SO,, CO, Attachment 1 1000 mg/ g. The equation for calculating compliance test pollutant emission rate ( E) is as follows:

C V * 6 0 E Where:

E = Pollutant emission rate (@ our);

C = Concentration of pollutant ( m F = Stack flow rate ( dscdmin @ I 60 min/ hr; and P S F * AS 453.593 * 2000 A E =

Where:

AE = Annual emission ( tons/ yr);

ant/ Steam factor ( g pollutant/ lb steam);

AS = Annual steam flow for unit ( Ib steady);

453.593 gjIb; and 2000 lb/ ton.

Since some of the pollutant concentration data in the compliance tests were not given in mg/ dscm,

conversion factors were calculated and used to convert the given values into mgld convert the poilut multipiied by the conversion factor. The conversion factors that were used are given in the following table. concentration to mg/ dscm the concentration value ( ppmV or ng/ dscm} is Attachment 2 The purpose of this section is to provide a sample calculation to show the steps and equations that are used to calculate the Combustor ( MWC) units. A 750 ton p calculation. Sample calculations are sho om large Municipal Waste Sample Calculation ( 750 TPD MWC Unit):

Flue gas rate during compliance test ( F)

Steam rate during compliance rest ( SF)

Steam generation per year ( AS) = I P Dioxifluran, Total M Concentration of CDD/ CDF, total mass b Using the conversion ,

Thus, E= 1.6~ 10~~* 2159* 60/ tOOO E = 2.07 x IO4 f i r PSF = 2.07 x lo4 / 184,500 PSF = 1. f 2338 x 1 0 9 gllb steam AE = 1.12338 x io" * 1,433,041,000 AE = 1.61 g/ yr CDD/ CD ersion from tons to grams)

DioxinsJFurans, TEQ Basis:

6 C:\ SmaliMWC\ Oocket\ 70802submittal\ A9045d Concentration of CDDICDF, TEQ basis = 0.032 ng/ dscm ( given)

Using the conversion factor the CDD/ CDF concentration is 3.2 x IO' mg/ dscm Thus, E = 3.2 x lo' * 2159 * 60 / 1000 E = 4.1453 x IOv6 g/ hr PSF = 4.1453 x PSF = 2.2468 x 10'" g/ lb steam / 184,500 Mercury ( Hg):

Concentrarion of Hg = 0.0197 mgldscm ( given)

Thus, E = 0.0197 * 2159 * 60 / 1000 PSF = 2.55 I9 / 184,500 PSF = 1.383 x g/ Ib steam AE = 1.383 x to' * 1,433,04Z, oOO / ( 453.593 * 2000)

AE = 0.02 18 ton/ yr Hg Lead ( plb):

I Doeket\ 7O802su bmittafV49045viiibS. wpd 7 , I Concentration of Pb = 0.039 mgldscm ( given)

Thus, E = 0.039 * 2 60 / 1000 E = 5.052 g h r PSF = 5.052 / 184,500 PSF = 2.738 x IO' g/ lb steam AE = 2.738 x *

AE = 0.0433 todyr Pb Cahaium ( Cd):

Concentration of Cd = 0.0033 mgldscm ( given)

Thus, E = 0.0033 * 2159 * 60 / 1000 E = 0.4275 g/ hr PSF = 0.4275 / 184,500 7 x ! O 6 g/ Ib steam AE = 2.3 17 x lo6 * 1,433,041,000 J ( 453.

AE = 0.00366 todyr Cd Hydrochloric Acid ( HCl):

Concentration of HCl = 9.4 ppmV ( given) Using the conversion factor the HCI concentration is 14.25 mg/ dscm Thus, E = 14.25 * 2159 * 601 1000 E = I846 g/ hr PSF = 1846 / 184,500 PSF = 0.01 g/ lb steam AEi = 0.01 * 1,433,041,000 / ( 453.593 * 2000)

AE = 15.8 todyr HCI Sulfur Dioxide ( SO&

The concentration of SO, = 4.9 ppmV ( given)

Using the conversion factor the SO, concentration is 13.05 mg/ dscm Thus, E = 13.05 * 2159 * 60 / 1000 E = 1690 g/ hr PSF = 1590 /` 184,500 PSF = 0.00916 g/ lb steam AE = 0.009 16 * 1,433,041,000 / ( 453.593 * 2000)

AE = 14.5 ton/ yr SO,

Nitrogen Oxides ( Nod: Thus,

E = 350 * 2159 * 60 / LO00 E = 45,324 PSF = 45,324 /' 184.500 PSF = 0.24566 gRb steam i AE = 0.24566 * I, 433,041,000 / ( 453.593 * 2000) I AE = 388 todyr NO,

Particuiate Matter ( PM):

Concentration of PM = 7.3 mgldscm (

Thus, *

E = 7.3 * 2159 * 60 / lo00 E = 945.6 g h r  J PSF = 945.6 / 184,500 PSF = 0.005 126 g/ lb steam

AE = O. 005126 * 1,433,041 1 AE = 8.10 toniys PM


[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Page 79079]
[FR Doc No: 2010-31515]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent to Rule on Request to Release Airport Property
at New Century AirCenter, New Century, Kansas

AGENCY: Federal Aviation Administration, (FAA), DOT.

ACTION: Notice of request to release airport property.

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

SUMMARY: The FAA proposes to rule and invites public comment on the
release of land at New Century AirCenter under the provisions of
Section 125 of the Wendell H. Ford Aviation Investment Reform Act for
the 21st Century (AIR 21).

DATES: Comments must be received on or before January 18, 2011.

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Federal Aviation Administration,
Central Region, Airports Division, 901 Locust, Kansas City, Missouri
64106-2325.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to R.E. Metcalfe, A.A.E., Executive Director,
Johnson County Airport Commission, One New Century Parkway, New
Century, Kansas, 66031.

FOR FURTHER INFORMATION CONTACT: Nicoletta Oliver, Airports Compliance
Specialist, FAA, Central Region, 901 Locust, Kansas City, MO 64106-
2325,<PHONE_NUMBER>.
    The request to release property may be reviewed in person at this
same location.

SUPPLEMENTARY INFORMATION: The FAA proposes to rule and invites public
comment on the request to release property at New Century AirCenter
under the provisions of AIR21.
    On December 3, 2010, the FAA determined that the request to release
property at New Century AirCenter, submitted by the Johnson County
Airport Commission, met the procedural requirements of the Federal
Aviation Administration. The FAA will approve or disapprove the
request, in whole or in part, no later than February 15, 2011.
    The following is a brief overview of the request.
    The Johnson County Airport Commission requests the release of
approximately 9.81 acres of airport property. The land is currently not
being used for aeronautical purposes. This parcel has a building
constructed by a private developer for commercial use. The purpose of
this release is to sell the land to the Johnson County Parks and
Recreation Board who intends to convert the building to an indoor
soccer facility with outdoor fields adjacent to the building and within
the boundary of the parcel. The sale of this property will generate
fair market value revenue for the airport.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the application,
notice and other documents that are relevant to the request, in person
at New Century AirCenter, New Century, Kansas.

    Issued in Kansas City, Missouri, on December 10, 2010.
Rodney N. Joel,
Acting Manager, Airports Division, Central Region.
[FR Doc. 2010-31515 Filed 12-16-10; 8:45 am]
BILLING CODE 4910-13-M


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Wednesday, September 14, 2016 2:14 PM
To:
Jonelle S Scheetz<EMAIL_ADDRESS>Cc:
Terry L Redenbaugh<EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
RE: U. S. Steel Clairton Works - ICR Test Question

The answers, I have been told, are as follows:

1.        Use the WHO 2005 factors.
2.        ND should be set equal to the estimated detection limit (EDL)
3.        Please submit lab data as an attachment to the ERT.

If this doesn't help your issue, let me know.
_____________________________________________________________
Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D 243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

From: Jonelle S Scheetz<EMAIL_ADDRESS>Sent: Wednesday, September 14, 2016 10:37 AM
To: Jones, DonnaLee<EMAIL_ADDRESS>Cc: Terry L Redenbaugh<EMAIL_ADDRESS>Subject: U. S. Steel Clairton Works - ICR Test Question

Dr. Jones,

I was looking for some guidance on the question below that was submitted from the lab that is conducting water sample analysis.

TEQ  -  it is noted in the table on page 15 of 40 to report TEQs.  This is a calculation using the individual homologue results multiplied by toxicity factors (there are several sources of factors) and usually includes the OCDF and OCDF in the calculation.  There are also different ways to do the calculation with regards to ND (not detect) results.  Use a value of ND=`0', use a value of ND=0.5xEDL, or use a value of ND=EDL, where the EDL is the estimated detection limit.  So two questions:  1.  Which toxicity factors should we be using for the calculation (I believe most folks use the WHO 2005 factors) and 2.  Which way should the ND results be treated?

Thank you,

Jonelle Scheetz
Clairton Environmental
United States Steel Corporation
Office:<PHONE_NUMBER>
Cell:<PHONE_NUMBER>


                             Summary of Meetings
                          With St. Marys Cement (SMC)

Following the publication on August 6, 2012 of the notice of proposed rulemaking regarding Michigan's regional haze plan, EPA held three meetings with St. Marys Cement:

October 10, 2012 meeting
   	SMC attendees: Cortney Schmidt, Matt Gower, Celso Martini (by phone), Ann Straw, Fred Dindoffer (outside counsel)
   	EPA attendees: Douglas Aburano, John Summerhays, Jane Woolums, Dan Schaufelberger
   	Michigan attendees: Bob Irvine, Asad Khan (by phone)
   	Synopsis:  SMC presented its views on EPA's proposed BART requirements.  SMC asserted that the existing facility cannot achieve more than 15 percent reduction from selective noncatalytic reduction (SNCR) on a sustained basis, that the problems of material buildup that arise from use of SNCR could be solved by replacing the plant's pre-calciner, but SMC did not have the $18 million that such a project would require.  EPA noted the possibility of injecting lime to reduce the flue gas sulfur associated with material buildup; SMC responded that lime injection would not work.  SMC proposed that EPA set a limit of 4.85 pounds per ton of clinker, reflecting a 25 percent reduction from a value 3 standard deviations above mean emissions, to be achieved by reducing emissions 15 percent by SNCR and 10 percent by system changes.  EPA asked what system changes SMC contemplated;  SMC responded that it would investigate water injection, process control, staged combustion, and other options.  EPA primarily listened to SMC.

October 24, 2012 call
   	SMC attendees: Cortney Schmidt, Matt Gower, Ann Straw, Fred Dindoffer (outside counsel)
   	EPA attendees: Douglas Aburano, John Summerhays, Jane Woolums, Dan Schaufelberger
   	Michigan attendees: Bob Irvine
   	Synopsis:  SMC retracted its prior offer to achieve 25 percent NOx emission reduction.  SMC described a bypass system between its second and third stage preheater to reduce alkali in the flue gas.  SMC presented a graph showing that three standard deviations above and below the mean (in a normal distribution) account for 99.73 percent of the values.  EPA responded that the relevant statistic is not the percent of values within a set distance from the mean, but rather the total percent of values below a point the set distance above the mean, including all values down to zero.  SMC continued to characterize the value three standard deviations above the mean as the 99.73 percentile value.  SMC characterized SNCR efforts at its Bowmanville, Ontario plant as achieving 30 percent reduction with injection of ammonia with an equal molar ratio with flue gas NOx.  (This plant, identified as Plant A in a paper by Joe Horton of Suwannee American Cement (a sister company of SMC) was reported as achieving 53.5 percent reduction when tested with 0.56 moles ammonia per mole of NOx.)  SMC indicated that it believed that significant plant modifications in 1979, based on a February 1978 permit, meant that the plan as current configured was not operational in the BART eligibility period, so that the plant should not be considered subject to a requirement for BART.  SMC made arrangements with Michigan to visit the Michigan offices for historical information on the 1978 permit.

November 2, 2012 Meeting
   	SMC attendees: Celso Martini, Cortney Schmidt, Dirk Cox, Ann Straw, Fred Dindoffer (outside counsel)
   	EPA attendees: George Czerniak, Douglas Aburano, John Summerhays, Jane Woolums, Dan Schaufelberger
   	Michigan attendees: Bob Irvine (by phone)
   	Sypnosis:


[Federal Register: May 6, 2008 (Volume 73, Number 88)]
[Notices]
[Page 25073-25074]
[DOCID:fr06my08-125]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57737; File No. SR-Phlx-2008-28]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Regarding Position and Exercise Limits for Options on the DIAMONDS
Trust

April 29, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 24, 2008, the Philadelphia Stock Exchange, Inc. (``Exchange''
or ``Phlx'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
The Exchange has designated this proposal as non-controversial under
Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 1001 (Position Limits) to
establish increased position limits for options on the Diamonds Trust,
Series 1 (``DIA'' or ``DIA Options'').
    The text of the proposed rule change is available on the Exchange's
Web site (http://www.Phlx.com), at the offices of the Exchange, and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is proposing to amend Phlx Rule 1001 pertaining to
position limits for options on DIA. In particular, the Exchange
proposes to increase position limits for DIA Options to 300,000
contracts on the same side of the market, which should encourage a more
liquid and competitive market environment to the benefit of customers
interested in the product. The Commission previously approved a similar
proposal of the Chicago Board Options Exchange (``CBOE'').\5\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 47346 (February 11,
2003), 68 FR 8316 (February 20, 2003) (SR-CBOE-2002-26) (approving
an increase in the position limits and exercise limits to 300,000
for DIA options). The Commission stated that ``given the
surveillance capabilities of the [CBOE] and the depth and liquidity
in both the DIA options and the underlying cash market in DIAs, the
Commission believes it is permissible to significantly raise
position and exercise limits for DIA options without risk of
disruption to the options or underlying cash markets.'' The
Commission also stated that ``financial and reporting requirements .
. . should allow [CBOE] to detect and deter trading abuses arising
from the increased position and exercise limits, and will also allow
[CBOE] to monitor large positions in order to identify instances of
potential risk and to assess additional margin and/or capital
charges, if deemed necessary.''
---------------------------------------------------------------------------

    The Exchange also recently made permanent increased position limits
for certain equity options on Phlx, which were in effect on a pilot
basis.\6\ The Exchange stipulated, as part of its proposal for such
permanent approval, that ``its surveillance procedures . . . and
reporting procedures, in conjunction with the financial requirements
and risk management review procedures already in place at the clearing
firms and the Options Clearing Corporation, will serve to adequately
address any concerns the Commission may have respecting account(s)
engaging in manipulative schemes or assuming too high a level of risk
exposure.'' \7\ These representations also apply to the current
proposal to increase the position limits for DIA Options. The Exchange
now seeks to increase the position and exercise limits for options on
DIA on Phlx to the level that such limits are in effect on other
options exchanges such as BOX and CBOE (300,000 contracts on the same
side of the market).
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 57418 (March 3,
2008), 73 FR 12493 (March 7, 2008) (SR-Phlx-2008-14).
    \7\ Id.
---------------------------------------------------------------------------

    The Exchange believes that the justifications behind the
Commission's approval of CBOE's proposal to increase position limits on
DIA Options should support the same increased position limits on such
options on Phlx. Specifically, the Exchange believes that the
``structure of the DIA options and the considerable liquidity of both
the underlying cash and options market for DIA options lessen the
opportunity for manipulation of this product and disruption in the
underlying market that a lower position limit may protect against.''
\8\ The Exchange believes that the reporting requirements imposed under
the Phlx rules will help protect against potential manipulation.\9\
Additionally, the Exchange believes that an increase in position limits
on DIA Options on Phlx is also required for competitive purposes as
well as for purposes of consistency and uniformity among the competing
options exchanges. This, taken in conjunction with the permanent
establishment of other increased position limits for certain equity
options on Phlx,\10\ supports the Exchange's proposal related to
increased position limits applicable to DIA Options.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 47346, supra note 5.
    \9\ See Phlx Rule 1003.
    \10\ See Securities Exchange Act Release No. 57418, supra note
6. See also Securities Exchange Act Release No. 57597 (April 1,
2008), 73 FR 18846 (April 7, 2008) (SR-Phlx-2008-24) (IWM position
limits).

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

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \11\ in general, and furthers the objectives of Section
6(b)(5) of the Act \12\ in particular, in that it is designed to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
Specifically, the Exchange believes that the structure of the DIA
Options and the considerable liquidity of the market for such options
diminish the opportunity for manipulation of this product and for
disruption in the underlying market that a lower position limit may
protect against.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has designated the proposed rule change as one that:
(1) Does not significantly affect the protection of investors or the
public interest; (2) does not impose any significant burden on
competition; and (3) does not become operative for 30 days from the
date of filing, or such shorter time as the Commission may designate if
consistent with the protection of investors and the public interest.
Therefore, the foregoing rule change has become effective pursuant to
Section 19(b)(3)(A) of the Act \13\ and subparagraph (f)(6) of Rule
19b-4 thereunder.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has fulfilled this requirement.
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the operative delay
to permit the proposed rule change to become operative prior to the
30th day after filing. The Exchange states that waiving the operative
delay will allow the Exchange to immediately use position limits that
are currently available to other options exchanges. The Exchange
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest in that it would
establish the same position limits that are available to other options
exchanges.
    The Commission believes that waiving the 30-day operative delay of
the Exchange's proposal is consistent with the protection of investors
and the public interest.\15\ Therefore, the Commission designates the
proposal to be operative upon filing.
---------------------------------------------------------------------------

    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate the rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-Phlx-2008-28 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2008-28. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commissions Internet Web site (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for inspection and copying in the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of the Exchange. All comments received
will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2008-28 and should be submitted on
or before May 27, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-9867 Filed 5-5-08; 8:45 am]

BILLING CODE 8010-01-P