[Federal Register: September 19, 2008 (Volume 73, Number 183)]
[Notices]
[Page 54407-54408]
[DOCID:fr19se08-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0394]

Guidance for Industry: Regulation of Genetically Engineered
Animals Containing Heritable rDNA Constructs; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance document (GFI187) entitled
``Regulation of Genetically Engineered Animals Containing Heritable
rDNA Constructs.'' This draft guidance is intended to clarify FDA's
requirements and recommendations for producers and developers of
genetically engineered (GE) animals and their products. The draft
guidance describes how the new animal drug provisions of the Federal
Food, Drug, and Cosmetic Act (the act) apply with respect to GE
animals, including FDA's intent to exercise enforcement discretion
regarding requirements for certain GE animals.
    Elsewhere in this same issue of the Federal Register, the Animal
and Plant Health Inspection Service (APHIS) is soliciting public
comment on any potential implications of activities such as the
importation or interstate movement of GE animals on the health of the
U.S. livestock population under the authority of the Animal Health
Protection Act (AHPA).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by November 18, 2008.

ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Communications Staff (HFV-12), Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
that office in processing your requests.
    Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:  Larisa Rudenko, Center for Veterinary
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    For the purpose of this guidance, FDA defines ``genetically
engineered (GE) animals'' as those animals modified by recombinant DNA
(rDNA) techniques. The term GE animal can refer to both animals with
heritable rDNA constructs and animals with non-heritable rDNA
constructs (e.g., those modifications intended to be used as gene
therapy). Although much of this guidance will be relevant to non-
heritable rDNA constructs, and FDA intends to regulate non-heritable
constructs in much the

same way as described in this guidance for heritable constructs, this
guidance only pertains to GE animals containing heritable rDNA
constructs. We may issue a separate guidance on the regulation of GE
animals bearing non-heritable constructs to discuss when those
constructs would be under FDA jurisdiction and the kinds of information
that would be relevant for FDA's review.
    FDA's authority over new animal drugs comes from the Federal Food,
Drug, and Cosmetic Act. The definition of a drug, in section 201(g) of
the act (21 U.S.C. 321(g)), includes ``articles intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease in man
or other animals;'' and ``articles (other than food) intended to affect
the structure or any function of the body of man or other animals.''
The rDNA construct in a GE animal that is intended to affect the
structure or function of the body of the GE animal, regardless of the
intended use of products that may be produced by the GE animal, meets
the act drug definition. The draft guidance describes how the new
animal drug provisions of the act apply with respect to GE animals,
including FDA's intent to exercise enforcement discretion regarding
requirements for certain GE animals.
     FDA is one of several Federal agencies that share regulatory
oversight of GE organisms. In 1986, the Office of Science and
Technology Policy (OSTP) under the Executive Office of the President
published a policy document known as the Coordinated Framework for the
Regulation of Biotechnology (the Coordinated Framework).\1\ This policy
document describes the system for coordinating the activities of the
Federal agencies responsible for regulating all GE organisms.\2\
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    \1\Coordinated Framework for the Regulation of Biotechnology:
June 26, 1986; 51 FR 23302; http://usbiotechreg.nbii.gov/
CoordinatedFrameworkForRegulationOfBiotechnology1986.pdf.
    \2\In addition to discussing the regulatory responsibilities of
these agencies for GE organisms and other products, the Coordinated
Framework also discusses the responsibilities of agencies with
jurisdiction over GE research (the National Institutes of Health,
the National Science Foundation, the Environmental Protection Agency
(EPA), and the U.S Department of Agriculture's (USDA's) Agricultural
Research Service).
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    In addition to FDA's role in oversight of GE animals, APHIS is
authorized, under the AHPA (7 U.S.C. 8301 et seq.), to protect the
health of U.S. livestock by preventing the introduction and spread of
livestock diseases and pests into and within the United States. Based
on that authority, APHIS may broadly consider the potential effects of
animals with GE traits on the health of the overall U.S. livestock
population, while FDA is more focused on the direct effects of genetic
engineering on individual animals based on its authority under the act.
Given these complementary authorities, FDA and APHIS have been
discussing their respective roles in overseeing GE animals for some
time. In conjunction with FDA's release for public comment of its
guidance on GE animals, APHIS is soliciting public comment in this same
issue of the Federal Register on any potential implications of
activities such as the importation or interstate movement of GE animals
on the health of the U.S. livestock population.

II. Significance of Guidance

    This Level 1 draft guidance is being issued consistent with FDA's
Good Guidance Practices regulation (21 CFR 10.115). This draft
guidance, when finalized, will represent the agency's current thinking
on the topic. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
method may be used as long as it satisfies the requirements of
applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information have been approved under OMB Control Nos.
0910-0032, 0910-0045, 0910-0117, and 0910-0284. FDA seeks public
comment on the agency's determination that the previously approved
collections of information referred to previously adequately account
for the collections of information referenced in this guidance.
Although the collections of information burden estimates previously
approved by OMB were derived for new animal drug applications (NADAs)
in general, FDA believes that such estimates are applicable to NADAs
for GE animals. In particular, FDA previously determined that preparing
the paperwork required for an NADA under 21 CFR 514.1 will take
approximately 212 hours. Over the past 5 fiscal years, FDA has received
an average of 19 NADAs per year.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/cvm or http://www.regulations.gov.

    Dated: September 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21917 Filed 9-18-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 229 (Monday, November 30, 2015)]
[Notices]
[Pages 74829-74831]
[FR Doc No: 2015-30242]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76506; File No. SR-ISE-2015-30]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing of Proposed Rule Change To Amend Rule 804(g)

November 23, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 10, 2015, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission the proposed rule change, as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 804(g) to require Clearing
Member approval for market makers to resume trading after a market-wide
speed bump is triggered. The text of the proposed rule change is
available on the Exchange's Web site (http://www.ise.com), at the
principal office 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 self-regulatory organization
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 self-regulatory organization
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 purpose of the proposed rule change is to amend Rule 804(g) on
``Automated Quotation Adjustments'' to

require Clearing Member \3\ approval for Primary Market Makers
(``PMMs'') and Competitive Market Makers (``CMMs'') (collectively,
``market makers'') to resume trading after a market-wide speed bump is
triggered. The Exchange offers market makers functionality whereby the
Exchange will automatically remove a market maker's quote in all series
or complex order strategies in an options class if a ``curtailment
event'' occurs based on parameters set by the market maker on a class-
by-class basis.\4\ In particular, the Exchange will automatically
remove a market maker's quote in a class when, during a time period
established by the market maker, the market maker exceeds: (i) The
specified number of total contracts in the class, (ii) the specified
percentage of the total size of the market maker's quotes in the class,
(iii) the specified absolute value of the net between contracts bought
and contracts sold in the class, or (iv) the specified absolute value
of the net between (a) calls purchased plus puts sold in the class, and
(b) calls sold plus puts purchased in the class.\5\ In addition, the
Exchange provides market-wide functionality whereby a market maker's
quote in all options classes are automatically cancelled if, during a
configurable time period, the total number of curtailment events in
simple and complex instruments exceeds a market-wide parameter set by
the market maker.\6\ This market-wide functionality, which is available
for ISE only or across both ISE and ISE's affiliate, ISE Gemini,
LLC,\7\ is useful to members as numerous curtailment events triggered
across multiple options classes, and if chosen, multiple exchanges, may
signify a larger problem being experienced by the market maker that
warrants its quotes being removed from the market. Currently, the
Exchange only requires that a market maker notify Market Operations of
its intention to reenter the market to resume trading after the market-
wide speed bump has been activated. Due to the significant nature of
events that may trigger this market-wide speed bump functionality, the
Exchange now proposes also to require Clearing Member approval prior to
allowing the market maker to resume quoting. Pursuant to the proposed
rule change, a market maker must notify its Clearing Member(s) when it
is ready to resume trading following a market-wide speed bump. Exchange
staff may also notify the Clearing Member(s) when the market maker's
quotes have been removed, to facilitate a better response time. Each
Clearing Member must then contact the Exchange directly to give their
authorization for the market maker to resume trading.\8\
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    \3\ The term ``Clearing Member'' means a Member that is self-
clearing or an Electronic Access Member that clears Exchange
Transactions for other Members of the Exchange. See Rule 100(a)(8).
    \4\ See Rule 804(g)(i) for simple instruments, and Supplementary
Material .04 to Rule 722 for complex instruments.
    \5\ Id.
    \6\ See Rule 804(g)(ii). This functionality is known as
``market-wide speed bump'' and is the subject of this filing.
    \7\ Id.
    \8\ If a market maker has multiple Clearing Members, it must
receive approval from each Clearing Member to resume trading.
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    Each market maker authorized to trade on the Exchange must obtain
from a Clearing Member a ``Market Maker Letter of Guarantee'' wherein
the Clearing Member accepts financial responsibility for all Exchange
transactions made by the market maker.\9\ The Exchange believes that it
is appropriate to require Clearing Member approval before a market
maker can reenter the market after the market-wide speed bump has been
triggered as the Clearing Member guarantees the market makers trades,
and therefore bears ultimate financial risk associated with those
transactions. The Exchange notes that while not all market makers are
Clearing Members, all market makers require a Clearing Member's consent
to clear transactions on their behalf in order to conduct business on
the Exchange. As the Clearing Member ultimately bears the risk for a
trade they clear on any market makers behalf, the Exchange believes it
is reasonable to require that the Clearing Member authorize the market
maker to continue trading after the market-wide speed bump is
triggered.
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    \9\ See Rule 808.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6(b) of the Act.\10\ In
particular, the proposal is consistent with Section 6(b)(5) of the
Act,\11\ because it is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change removes
impediments to and perfects the mechanism of a free and open market by
requiring that Clearing Members authorize continued trading by a market
maker after that market maker triggers a market-wide speed bump. The
Exchange believes that the proposed rule change is consistent with the
protection of investors and the public interest because it will permit
Clearing Members with a financial interest in a market maker's risk
management to better monitor and manage the potential risks assumed by
that market maker. The Exchange already shares market makers' risk
settings with their Clearing Members in order to assist those Clearing
Members in monitoring risks at firms on whose behalf they clear
trades.\12\ The proposed rule change would further assist Clearing
Members in monitoring risk, and provide these Clearing Members with
greater control and flexibility over their risk tolerance and exposure.
Because the Clearing Member guarantees all of the market maker's trades
it is in a unique position to objectively evaluate the risk of a market
maker reentering the market following a serious systems or other issue.
While in some cases this may result in a minimal delay for a market
maker that wants to reenter the market quickly following a market-wide
speed bump, the Exchange believes that Clearing Member approval is
appropriate to ensure that the market maker does not prematurely enter
the market without adequate safeguards in place.
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    \12\ See Securities Exchange Act Release No. 74623 (April 1,
2015), 80 FR 18447 (April 6, 2015) (SR-ISE-2015-12).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes the proposal is consistent with Section
6(b)(8) of the Act \13\ in that it does not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The proposed rule change is not designed to
address any aspect of competition, but is rather intended to provide
additional safeguards by requiring Clearing Member approval before
market makers are allowed to reenter the market following a market-wide
speed bump. The Exchange believes that this would allow Clearing
Members to better monitor and manage the potential risks assumed by
market makers on whose behalf they have executed a Market Maker Letter
of Guarantee, and does not

impose any unnecessary burden on competition.
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    \13\ 15 U.S.C. 78f(b)(8).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Within 45 days of the publication date of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

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 email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2015-30 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2015-30. This file
number should be included on the subject line if email 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 Commission's 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the 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-ISE-2015-30 and should be
submitted on or before December 21, 2015.
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    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-30242 Filed 11-27-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Pages 45575-45576]
[FR Doc No: 2015-18675]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2015-0059]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA confirms its decision to exempt 51 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on June 11, 2015. The exemptions
expire on June 11, 2017.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Carrier, Driver and Vehicle Safety Standards,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Room W64-224, Department of
Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
Office hours are from 8:30 a.m. to 5 p.m., Monday through Friday,
except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On May 11, 2015, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 51 individuals and requested
comments from the public (80 FR 26979). The public comment period
closed on June 10, 2015, and two comments were received.
    FMCSA has evaluated the eligibility of the 51 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 51 applicants have had ITDM over a range of one to 33 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated

and discussed in detail in the May 11, 2015, Federal Register notice
and they will not be repeated in this notice.

III. Discussion of Comments

    FMCSA received two comments in this proceeding. The comments are
addressed below.
    Doreen Dupont stated that, as a licensed physician, she does not
believe any insulin-dependent drivers should be granted exemptions to
operate CMVs in interstate commerce.
    Alvin Williams stated he wants to renew his Class A driver's
license but would like to know if a restricted Class A license is
available so he does not have to downgrade.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Conclusion

    Based upon its evaluation of the 51 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above 49 CFR
391.64(b)):

Galen W. Abitz (IA)
Kenneth V. Bartlett (PA)
Derek A. Becker (IL)
Robert J. Boardwick (NJ)
Delano W. Brede (IA)
Stanley L. Buckley (WI)
Matthew J. Burris (MN)
Robert E. Clark, Jr. (VA)
Stephen M. Cooper (WI)
George L. Crockett (OH)
Thomas J. Cummings (IA)
Gary E. Davidge (MD)
Delawrence D. Dillard (IL)
Stephen L. Drake (TX)
Kevin P. Fulcher (MA)
Cecil E. Glenn (CA)
David E. Goddard, Jr. (WV)
Wesley H. Green (OK)
David H. Heins (IL)
Thomas P. Henry (VA)
Leslie W. Holmes (DE)
Korry W. Hullinger (UT)
James V. Kuhns, Jr. (PA)
Craig C. Leckie (OR)
Robert T. Lee (WI)
Tyler S. Lewis (AK)
Zackery L. Lowe (VA)
Eugene T. Mapp (SC)
Edward W. Masser (PA)
Robert S. Medberry (OH)
Brian L. Merlo (CA)
Brian K. Miesner (MO)
James D. Miller (MN)
Isse A. Moalin (AZ)
Patrick S. Murray (OK)
Douglas W. Olson (TX)
Lisa R. Olson (MT)
John C. Osterhout (ID)
Kevin J. Riedl (WI)
Richard E. Roberts (NC)
Ian L. Robinson (VA)
Stephen D. Sandine (AR)
Michael J. Simko (PA)
Steven L. Sobczak (WI)
Richard J. Tallen (IN)
Brett E. Thein (GA)
Ryan R. Turnbull (NY)
Jonathan C. Walston (IA)
Graciano Wharton-Ramirez (NJ)
Rick G. White (WA)
Randall L. Williamson (IL)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: July 20, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-18675 Filed 7-29-15; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 172 (Tuesday, September 6, 2011)]
[Notices]
[Pages 55079-55081]
[FR Doc No: 2011-22630]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2011-0674]

Recreational Vessel Accident Reporting

AGENCY: Coast Guard, DHS.

ACTION: Notice of Advisory Committee recommendations; request for
additional public comments.

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SUMMARY: The Coast Guard has received recommendations from the National
Boating Safety Advisory Council (NBSAC) regarding potential ways to
improve the recreational boating accident reporting process. NBSAC
recommended that the Coast Guard: (1) Use a two-tiered reporting system
for boating accidents; and (2) take steps to clarify what, how, and
when information is reported. This notice solicits public comment on
the NBSAC recommendations, as well as general public comment on the
burden involved in reporting accidents, and other alternative means of
reporting or collecting information.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before December 5,
2011 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0674 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or e-mail Mr. Jeff Ludwig, Office of Auxiliary and Boating Safety,
Boating Safety Division, Coast Guard; telephone<PHONE_NUMBER>, e-mail

<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Ms. Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to submit comments and related material on the
National Boating Safety Advisory Council (NBSAC) recommendations and
related questions posed in this notice. All comments received will be
posted, without change, to http://www.regulations.gov and will include
any personal information you have provided.
    Submitting comments: If you submit a comment, please include the
docket number for this notice (USCG-2011-0674), and provide a reason
for each suggestion or recommendation. You may submit your comments and
material online, or by fax, mail, or hand delivery, but please use only
one of these means. We recommend that you include your name and a
mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
insert ``USCG-2011-0674'' in the ``Keyword'' box. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit them by mail and would like to know that they
reached the Facility, please enclose a stamped, self-addressed postcard
or envelope. We will consider all comments and material received during
the comment period.
    Viewing comments and National Boating Safety Advisory Council
recommendations: To view the comments and the National Boating Safety
Advisory Council (NBSAC) recommendations, go to http://www.regulations.gov. In the ``Keyword'' box insert ``USCG-2011-0674''
and click ``Search.'' If you do not have access to the internet, you
may view the docket online by visiting the Docket Management Facility
in Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. We have an agreement with the Department of Transportation to
use the Docket Management Facility.
    Privacy Act: Anyone can search the electronic form of comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act, system of records notice regarding our public dockets in
the January 17, 2008 issue of the Federal Register (73 FR 3316).

Basis and Purpose

    In 2009, the National Boating Safety Advisory Council (NBSAC)
recommended that the Coast Guard revise its accident reporting
requirements. NBSAC is a Federal advisory committee under 5 U.S.C. App.
(Pub. L. 92-463). It was established under authority of 46 U.S.C. 13110
and advises the Secretary of the Department of Homeland Security
through the Coast Guard on boating safety regulations and other major
boating safety matters.
    The NBSAC recommendations were intended to help the Coast Guard
improve the quality and timeliness of boating accident information. The
Coast Guard relies on accident information provided by recreational
boat operators to make decisions aimed at improving boating safety.
This information, described in title 33 Code of Federal Regulations
(CFR) parts 173 and 174, is often collected from the owner or operator
of a vessel, who fills out a very detailed Coast Guard Boating Accident
Report (BAR, form CG-3865) or a similar form provided by the State
reporting authority. After an accident, the owner or operator of a
vessel involved must:
     Report the accident to the appropriate State reporting
authority within a specified timeframe; and
     Provide the information required in 33 CFR 173.57.
    The State reporting authority is then required by 33 CFR 174.101
and 174.121 to:
     Review each report for accuracy and completeness;
     Determine the cause of the accident based on the available
information; and
     Forward the accident report to the Coast Guard within 30
days of receiving the report.
    The Coast Guard receives reports of boating accidents from the
States and other sources and uses this information to meet its
statutory responsibilities to promote the safety of the recreational
vessel, its associated equipment, and the operator and passengers (see
46 U.S.C. Chapter 43). The Coast Guard also has a statutory obligation
to publish statistics on boating safety (see 46 U.S.C. 6102). Each
year, information received through the accident reporting system is
compiled and published in a report entitled ``Boating Statistics'',
Commandant Publication (COMDTPUB) P16754 (series).
    Unfortunately, many accidents are not reported, or the information
provided by boat owners or operators is often inaccurate or incomplete
and frequently becomes available to the Coast Guard long after an
accident occurs. Incomplete, inaccurate, or late accident information
makes ensuring safe boating conditions more difficult, and may indicate
that the accident reporting system could be improved.
    To address these issues, NBSAC recommended that the Coast Guard
establish a two-tiered notification/reporting system that would ease
the reporting burden on the owner or operator of a vessel, but would
place more responsibilities on State reporting authorities. NSBAC also
recommended a number of steps to be taken to clarify what, how, and
when information is reported. The specific NBSAC recommendations can be
found in the docket for this notice.
    Through this notice and request for comments, the Coast Guard hopes
to receive additional information from the public that will help us
improve the quality and timeliness of boating accident information. Our
goal is to receive information that will allow us to achieve the
following:
     Reduce the accident reporting burden on the public;
     Increase the number of accidents reported to the State
reporting authorities;
     Improve the timeliness of accident reports; and
     Increase the accuracy and completeness of reports
forwarded by the State reporting authorities to the Coast Guard.
    In this notice, we specifically seek information and public
comments relating to the following questions:
    1. Would the States support, and are some States already informally
using, the two-tiered accident reporting system that NBSAC has
recommended, with the boat operator providing a notification to the
State (via local law enforcement, first responder, etc.) and the State
reporting authority ensuring that a follow-up investigation is
conducted?
    2. Would the public support the two-tiered accident reporting
system that NBSAC has recommended?
    3. Would the two-tiered accident reporting system that NBSAC has
recommended improve the number of accident reports received?
    4. Would the two-tiered accident reporting system that NBSAC has

recommended improve the accuracy of accident reports received?
    5. Would the two-tiered accident reporting system that NBSAC has
recommended improve the timeliness of accident reports received?
    6. Would the two-tiered accident reporting system that NBSAC has
recommended ease the burden of accident reporting on owners or
operators of recreational vessels? If so, by how much?
    7. Would the two-tiered accident reporting system that NBSAC has
recommended increase the burden of accident reporting on State
reporting authorities? If so, by how much?
    8. Would any additional time (over the current system) be required
for the owner/operator in a reporting system where the State had to
contact him/her for information? If so, how many minutes of additional
time per report would be required for the owner/operator?
    9. Would any additional time (over the current system) and/or
resources be required for a State employee to complete the report as
opposed to the owner/operator? If so, how many minutes of additional
time per report and/or what additional resources?
    10. How many States currently use an electronic reporting system?
    11. How many States are considering using an electronic reporting
system?
    12. Would the use of an Internet reporting system reduce the time
required by the State to report information to the Coast Guard? If so,
how many minutes of time per report would be saved?
    13. Do any States collect data in addition to what is currently
required in 33 CFR 173.57? If so, what additional information is
collected?
    14. How many boating accident report forms (BAR, CG-3865 or State
equivalent forms) does a State receive from the public annually
(approximately)?
    15. How many boating accidents does a State investigate or cause to
be investigated annually (approximately)?
    16. How frequently (as a percentage) does a State collect data on
an accident for which no BAR form is submitted by the public?
    17. Under the current system, do States provide accident reporting
information that is the responsibility of the recreational vessel owner
or operator? If so, how many man-hours are required to collect this
information (please give time as hours per week or month or as an
average per accident report)?
    18. If a State provides information that is the responsibility of
the vessel owner or operator, what is the average time required by a
State employee to complete the entire accident report form under the
current system?
    19. Under the current system, how much time does a State reporting
authority spend validating the accident report submitted by a
recreational vessel owner or operator (please give time as hours per
week or month or as an average per accident report)?
    20. Under the current system, what percentage of reports that a
State receives from owner/operators are illegible or otherwise
unintelligible? How many man-hours are currently required to address
these problems (please give time as hours per week or month or as an
average per accident report)?
    21. Under the current system, when there is missing information
from the owner/operator, what is the average amount of time that passes
before a State employee is able to contact him/her in order to complete
the report? (please give time as hours per week or month or as an
average per accident report).
    22. Do boat owners/operators have enough information or expertise
to provide some or all of the accident reporting data currently
required by them in 33 CFR 173.57?
    23. What is the average time required for the owner/operator to
complete the report under the current system?
    24. Does the reporting of some or all of the accident reporting
data currently required in 33 CFR 173.57 result in adverse consequences
for owners/operators?
    25. How can owners or operators of recreational vessels be
encouraged to comply with boating accident reporting requirements?
    26. What is a reasonable amount of time for a State reporting
authority to submit a complete accident investigation report to the
Coast Guard?
    27. What percentage of a State's accident reports are reported to
Coast Guard within 30/60/90 days? What are the significant factors that
cause a report to be delayed beyond the 30 days?
    28. What is a good definition of an injury that required medical
treatment beyond first aid? Should the Occupational Safety and Health
Administration (OSHA) standards for ``medical treatment beyond first
aid'' be adopted as the standard for recreational boating injury
reporting? (see 29 CFR 1904.7(b)(5) for the OSHA standards)
    29. How should boating-related swimming incidents be defined? The
NBSAC recommendation suggests that incidents where the vessel was being
used as a swimming platform and/or a person voluntarily leaves the
vessel as the first event, whether the vessel was underway or not,
should not be considered reportable boating accidents, although it
would continue counting incidents involving carbon monoxide poisoning,
in-water electrical shock or other boat-related caused accidents.
    This notice is issued under authority of 5 U.S.C. 552(a) and 33 CFR
part 173.

    Dated: August 26, 2011.
James A. Watson,
Rear Admiral, U.S. Coast Guard, Director of Prevention Policy.
[FR Doc. 2011-22630 Filed 9-2-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Notices]
[Page 33080]
[DOCID:fr11jn08-42]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR08-25-000]

Kinder Morgan Texas Pipeline LLC; Notice of Petition for Rate
Approval

June 4, 2008.
    Take notice that on May 30, 2008, Kinder Morgan Texas Pipeline LLC
(KMTP) filed a petition for rate approval pursuant to section
284.123(b)(2) of the Commission's regulations. KMTP requests that the
Commission approve market-based rates for firm and interruptible
storage services provided at its North Dayton Gas Storage Facility,
located in Liberty County, Texas and at its Markham Gas Storage
Facility located in Matagorda County, Texas commencing on May 30, 2008.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern time Friday, June 20, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-13027 Filed 6-10-08; 8:45 am]

BILLING CODE 6717-01-P