[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Rules and Regulations]
[Pages 20850-20853]
[FR Doc No: 2011-8874]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2010-0545; FRL-9295-1]

Approval and Promulgation of Air Quality Implementation Plans;
Indiana; Stage I Vapor Recovery Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is approving into the Indiana State Implementation Plan
(SIP), amendments to the stage I vapor recovery rule and administrative
changes to stage II vapor recovery rule submitted by the Indiana
Department of Environmental Management on June 11, 2010. These rule
revisions made volatile organic compounds (VOC) emission control
requirements for filling at gasoline dispensing facilities more
stringent by applying them statewide, making the rule applicable to
smaller tanks and revising the requirements for newer submerged fill
pipes. These new State requirements update the SIP consistent with new
Federal requirements from January 10, 2008 area source National
Emissions Standards for Hazardous Air Pollutants (NESHAPs) for gasoline
dispensing facilities. The revisions also delete references to
compliance dates which have passed. The rules are approvable because
they are consistent with the Clean Air Act (Act) and EPA regulations,
and should result in additional emission reductions of VOCs throughout
Indiana.

DATES: This direct final rule will be effective June 13, 2011, unless
EPA receives adverse comments by May 16, 2011. If adverse comments are
received, EPA will publish a timely withdrawal of the direct final rule
in the Federal Register informing the public that the rule will not
take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2010-0545, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Doug Aburano, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Doug Aburano, Chief, Control Strategies Section,
Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77
West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are
only accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2010-0545. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any

personal information provided, unless the comment includes information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Do not submit
information that you consider to be CBI or otherwise protected through
http://www.regulations.gov or e-mail. The http://www.regulations.gov
Web site is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through http://www.regulations.gov your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Environmental
Protection Agency, Region 5, Air and Radiation Division, 77 West
Jackson Boulevard, Chicago, Illinois 60604. This Facility is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal
holidays. We recommend that you telephone Carolyn Persoon,
Environmental Engineer, at<PHONE_NUMBER>, before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Carolyn Persoon, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What should I consider as I prepare my comments for EPA?
II. What is the background of the rule revisions?
III. What is EPA's analysis of the rule revisions?
IV. What action is EPA taking?
V. Statutory and Executive Order Reviews

I. What should I consider as I prepare my comments for EPA?

    1. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions--The EPA may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

II. What is the background of the rule revisions?

    On January 10, 2008, EPA issued new, more stringent National
Regulations for Gasoline Dispensing Facilities at 40 CFR part 63,
subpart CCCCCC, (73 FR 1945), promulgated under section 112 of the Act.
The gasoline dispensing standards in that rule apply nationwide to
subject sources of hazardous air pollutants identified in 40 CFR
63.11111.
    Indiana adopted new requirements to reflect the revised Federal
regulations. These revisions: (1) Remove past compliance dates (326 IAC
8-1-3); (2) extend applicability of the rules to facilities statewide
with a through-put of ten thousand (10,000) gallons per month or
greater (326 IAC 8-4-1); and (3) add new requirements for filling
gasoline storage tanks (326 IAC 8-4-6).
    Indiana placed notices for public comment periods in the Indiana
Register first on June 27, 2007 and the second notice on June 3, 2009.
Indiana placed notices of public hearing dates in four newspapers on
July 31, 2009. Indiana then held a public hearing on the proposed rule
on September 2, 2009. There were no comments. The proposed rule was
published in the Indiana Register on September 23, 2009, and no
comments were received. A second notice of hearing was published in the
Indiana Register on September 23, 2009 and a second public hearing was
held on November 4, 2009. No comments were received. The final rule was
adopted on November 4, 2009.

III. What is EPA's analysis of the rule revisions?

    The revisions to Indiana's stage I vapor recovery rule, 326 IAC 8-
1-3, 326 IAC 8-4-1 and 326 IAC 8-4-6, are approvable because they are
consistent with the Act and applicable EPA regulations, and should
result in additional VOC emission reductions. A description of the rule
revisions follows:
    326 IAC 8-1-3 Compliance schedules--This section deletes
subsections 8-1-3 (d) and (e), which had allowed for compliance date
extensions, because the applicable dates have long past.
    326 IAC 8-4-1 Applicability--This section expands the applicability
to all gasoline storage tanks at a gasoline dispensing facility with a
through-put of ten thousand (10,000) gallons per month or greater.
    326 IAC 8-4-6 Gasoline dispensing facilities--Section 6(a)(8)
decreases the tank cut off size required to meet the regulatory
standards for fueling from two thousand, one hundred seventy six
(2,176) to nine hundred forty-six (946) liters (575 to 250 gallons).
Section 6(b)(1) revises the requirements for submerged fill pipes for
existing and newer tanks. Fill pipes installed before November 9, 2006
must be no more than twelve (12) inches from the bottom of the tank,
and those installed after November 9, 2006 must be no more than six (6)
inches from the bottom of the tank.
    The expanded applicability and more stringent submerged fill
requirements will result in additional VOC reductions.

IV. What action is EPA taking?

    EPA is approving into the Indiana SIP revisions the entire stage I
and stage II vapor recovery rule. Although the only amendments to the
rule affected are sections 326 IAC 8-1-3, 326 IAC 8-4-1, and 326 IAC 8-
4-6, concerning stage I vapor recovery, and administrative changes to
stage II vapor recovery rule, we are approving the entire rule for
clarity and consistency.
    We are publishing this action without prior proposal because we
view this as

a noncontroversial amendment and anticipate no adverse comments.
However, in the proposed rules section of this Federal Register
publication, we are publishing a separate document that will serve as
the proposal to approve the State plan if relevant adverse written
comments are filed. This rule will be effective June 13, 2011 without
further notice unless we receive relevant adverse written comments by
May 16, 2011. If we receive such comments, we will withdraw this action
before the effective date by publishing a subsequent document that will
withdraw the final action. All public comments received will then be
addressed in a subsequent final rule based on the proposed action. The
EPA will not institute a second comment period. Any parties interested
in commenting on this action should do so at this time. Please note
that if EPA receives adverse comment on an amendment, paragraph, or
section of this rule and if that provision may be severed from the
remainder of the rule, EPA may adopt as final those provisions of the
rule that are not the subject of an adverse comment. If we do not
receive any comments, this action will be effective June 13, 2011.

V. Statutory and Executive Order Reviews

    Under the Act, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve State choices,
provided that they meet the criteria of the Act. Accordingly, this
action merely approves State law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by State
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have Tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on Tribal governments or preempt Tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Act, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 13, 2011. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: March 30, 2011.
Susan Hedman,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart P--Indiana

0
2. In Sec.  52.770 the table in paragraph (c) is amended by revising
the entries under Article 8 for ``8-1 General Provisions'' and ``8-4
Petroleum Sources'' to read as follows:

Sec.  52.770  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Indiana Regulations
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                                                        Indiana
    Indiana citation               Subject          effective date   EPA approval  date           Notes
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *

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                                   Article 8. Volatile Organic Compound Rules
----------------------------------------------------------------------------------------------------------------
8-1.....................  General Provisions......
8-1-0.5.................  Definitions.............      10/18/1995  11/3/1999, 64 FR
                                                                     59642.
8-1-1...................  Applicability...........        6/5/1991  3/6/1992, 57 FR
                                                                     8082.
8-1-2...................  Compliance methods......      12/15/2002  5/5/2003, 68 FR
                                                                     23604.
8-1-3...................  Compliance schedules....       5/15/2010  4/14/2011, [Insert
                                                                     page number where
                                                                     the document
                                                                     begins].
8-1-4...................  Testing procedures......       7/15/2001  9/11/2002, 67 FR
                                                                     57515.
8-1-5...................  Petition for                  11/10/1988  9/6/1990, 55 FR
                           site[dash]specific                        36635.
                           reasonably available
                           control technology
                           (RACT) plan.
8-1-6...................  New facilities; general        6/24/2006  6/13/2007, 72 FR
                           reduction requirements.                   32531.
8-1-7...................  Military specifications.  ..............  10/27/1982, 47 FR
                                                                     20586.
8-1-9...................  General record keeping         5/22/1997  6/29/1998, 63 FR
                           and reporting                             35141.
                           requirements.
8-1-10..................  Compliance                     5/22/1997  6/29/1998, 63 FR
                           certification, record                     35141.
                           keeping, and reporting
                           requirements for
                           certain coating
                           facilities using
                           compliant coatings.
8-1-11..................  Compliance                     5/22/1997  6/29/1998, 63 FR
                           certification, record                     35141.
                           keeping, and reporting
                           requirements for
                           certain coating
                           facilities using daily-
                           weighted averaging.
8-1-12..................  Compliance                     5/22/1997  6/29/1998, 63 FR
                           certification, record                     35141.
                           keeping, and reporting
                           requirements for
                           certain coating
                           facilities using
                           control devices.
                                                  * * * * * * *
8-4.....................  Petroleum Sources.
8-4-1...................  Applicability...........       5/15/2010  4/14/2011, [Insert
                                                                     page number where
                                                                     the document
                                                                     begins].
8-4-2...................  Petroleum refineries....  ..............  1/18/1983, 48 FR
                                                                     2127.
8-4-3...................  Petroleum liquid storage  ..............  2/10/1986, 51 FR
                           facilities.                               4912.
8-4-4...................  Bulk gasoline terminals.  ..............  1/18/1983, 48 FR
                                                                     2127.
8-4-5...................  Bulk gasoline plants....  ..............  1/18/1983, 48 FR
                                                                     2127.
8-4-6...................  Gasoline dispensing            5/15/2010  4/14/2011, [Insert
                           facilities.                               page number where
                                                                     the document
                                                                     begins].
8[dash]4[dash]7.........  Gasoline transports.....       11/5/1999  5/31/2002, 67 FR
                                                                     38006.
8-4-8...................  Leaks from petroleum            6/5/1991  3/6/1992, 57 FR
                           refineries; monitoring;                   8082.
                           reports.
8-4-9...................  Leaks from transports          11/5/1999  5/31/2002, 67 FR
                           and vapor collection                      38006.
                           systems; records.
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-8874 Filed 4-13-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Proposed Rules]
[Pages 44485-44487]
[FR Doc No: 2013-17830]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 50, 51, 70 and 71

[EPA-HQ-OAR-2010-0885, FRL-9836-5]

Implementation of the 2008 National Ambient Air Quality Standards
for Ozone: State Implementation Plan Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of extension of comment period.

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SUMMARY: The EPA is announcing an extension of the public comment
period on the Proposed Rule Regarding ``Implementation of the 2008
National Ambient Air Quality Standards for Ozone: State Implementation
Plan Requirements'' (June 6, 2013). The EPA is extending the comment
period that originally was scheduled to end on August 5, 2013. The
extended comment period will close on September 4, 2013. The EPA is
extending the comment period because of a request we received in a
timely manner.

DATES: Comments. Comments must be received on or before September 4,
2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0885, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Air and Radiation Docket and Information Center,
Attention Docket ID No. EPA-HQ-OAR-2010-0885, Environmental Protection
Agency, 1301 Constitution Ave. NW., Washington, DC 20460. Mail Code:
2822T. Please include two copies if possible. In addition, please mail
a copy of your comments on the information collection provisions to the
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), Attn: Desk Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.
     Hand Delivery: Air and Radiation Docket and Information
Center, Attention Docket ID No. EPA-HQ-OAR-2010-0885, Environmental
Protection Agency in the EPA Headquarters Library, Room Number 3334 in
the EPA West Building, located at 1301 Constitution Ave. NW.,
Washington, DC. The EPA/DC Public Reading Room is open from 8:30 a.m.
to 4:30 p.m. Eastern Standard Time (EST), Monday through Friday.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2010-0885. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
on-line at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment and with any CD you
submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters and any form of encryption and be free of any
defects or viruses. For additional information about the EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm. For additional instructions on submitting
comments, go to the SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in
www.regulations.gov. Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in www.regulations.gov or in hard copy
at the Air and Radiation Docket and Information Center in the EPA
Headquarters Library, Room Number 3334 in the EPA West Building,
located at 1301 Constitution Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For further general information on
this rulemaking, contact Dr. Karl Pepple, Office of Air Quality
Planning and Standards, U.S. Environmental Protection Agency, by phone
at<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>or Mr. Butch
Stackhouse, Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency, by phone at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>For information on the public
hearings, contact Ms. Pamela S. Long by phone at<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    Entities potentially affected directly by this proposal include
state, local and tribal governments. Entities potentially affected
indirectly by this proposal include owners and operators of sources of
emissions (volatile organic compounds (VOCs) and nitrogen oxides
(NOX)) that contribute to ground-level ozone formation.

B. What should I consider as I prepare my comments for the EPA?

    1. Submitting CBI. Do not submit CBI information to the EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information on a disk or
CD ROM that you mail to the EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed to be CBI must be submitted for inclusion in the public docket.
Information marked CBI will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.

     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

C. Where can I get a copy of this document and other related
information?

    In addition to being available in the docket, an electronic copy of
this notice will be posted at http://www.epa.gov/air/ozonepollution/actions.html#impl.

    Dated: July 17, 2013.
Mary E. Henigin,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. 2013-17830 Filed 7-23-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 39 (Tuesday, February 28, 2023)]
[Notices]
[Pages 12686-12688]
[FR Doc No: 2023-04003]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0333]

Richard M. Fleming; Denial of Hearing on Application for
Termination of Debarment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
denying Dr. Richard M. Fleming's (Dr. Fleming's) request for a hearing
and denying his application for termination of debarment under the
Federal Food, Drug, and Cosmetic Act (FD&C Act). Dr. Fleming has failed
to file information and analyses sufficient to create a basis for a
hearing concerning this action.

DATES: This order is applicable February 28, 2023.

ADDRESSES: You may be submit comments at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:

     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0333 for ``Richard M. Fleming; Denial of Hearing on
Application for Termination of Debarment.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, go to https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852,<PHONE_NUMBER>. Publicly available submissions may be seen in
the docket.

FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On April 24, 2009, Dr. Fleming, the president of, and sole
physician at, Fleming Heart and Health Institute, P.C. (FHHI), pled
guilty to one felony count of healthcare fraud, in violation of 18
U.S.C. 1347 and 2, and one felony count of mail fraud, in violation of
18 U.S.C. 1341 and 2. On August 20, 2009, the U.S. District Court for
the District of Nebraska entered a judgment of conviction against Dr.
Fleming on these counts and sentenced Dr. Fleming to 5 years of
probation. In pleading guilty to those offenses, Dr. Fleming admitted
that his convictions stemmed from two separate actions. Dr. Fleming,
through his practice at FHHI, performed various imaging studies and
submitted reimbursement claims to Medicare and Medicaid. Dr. Fleming's
felony healthcare fraud related to the submission of a reimbursement
claim. Dr. Fleming admitted to knowingly executing and attempting to
execute a scheme to defraud Medicare and Medicaid healthcare benefit
programs in connection with the delivery of and payment for healthcare
benefits, items, and services, namely by submitting payment claims for
tomographic myocardial perfusion imaging studies that he did not
actually perform. Dr. Fleming's felony mail fraud violation related to
money paid to him to conduct a clinical study of a soy chip food
product for the purpose of evaluating health benefits. As Dr. Fleming
admitted during his guilty plea, he received approximately $35,000 for
conducting a clinical trial, but he fabricated data for certain
subjects.
    By letter dated November 18, 2013, pursuant to section
306(b)(2)(B)(ii)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(ii)(I)),
FDA's Office of Regulatory Affairs (ORA) notified Dr. Fleming of its
proposal to debar him for 10 years based on those convictions. On
September 28, 2018, FDA debarred Dr. Fleming for 10 years from
providing services in any capacity to a person with an approved or
pending drug product application. Following that debarment, Dr. Fleming
made various submissions from September 2018 to October 2018, which FDA
construed as a petition for reconsideration and denied on November 28,
2018.
    On March 15, 2022, Dr. Fleming applied for termination of debarment
pursuant to section 306(d)(1) of the FD&C Act. Absent a conviction
reversal, FDA may grant an application to terminate debarment pursuant
to section 306(b)(2)(B) only when ``termination serves the interests of
justice and adequately protects the integrity of the drug approval
process'' (see section 306(d)(3)(B)).
    By letter dated July 12, 2022, ORA offered Dr. Fleming an
opportunity for a hearing under 21 CFR part 12 on a proposal to deny
his application for termination of debarment. In the letter, ORA stated
that, considering all the favorable and unfavorable information in
light of the remedial public health purposes underlying debarment,
terminating Dr. Fleming's debarment would not best serve the interests
of justice and would not adequately protect the integrity of the drug
approval process.
    Under the authority delegated by the Commissioner of Food and
Drugs, the Chief Scientist has considered Dr. Fleming's request for a
hearing. Hearings are granted only if there is a genuine and
substantial issue of fact. Hearings will not be granted on issues of
policy or law, on mere allegations, denials, or general descriptions of
positions and contentions, or on data and information insufficient to
justify the factual determination urged (see Sec.  12.24(b) (21 CFR
12.24(b))).

    The Chief Scientist has considered Dr. Fleming's arguments, as well
as the proposal to deny Dr. Fleming's application for termination of
debarment and concludes that there is no genuine and substantial issue
of fact requiring a hearing. Further, the Chief Scientist finds that
Dr. Fleming's application does not satisfy the grounds for terminating
debarment.

II. Arguments

    In his response to ORA's proposal to deny his request for
termination, Dr. Fleming concedes that the convictions underlying his
debarment pursuant to section 306(b)(2)(B)(ii)(I) of the FD&C Act have
not been reversed. FDA could therefore only terminate his debarment
under section 306(d)(3)(B) if the Agency determined that such
termination would serve the interests of justice and adequately protect
the integrity of the drug approval process. In the application to
terminate his debarment, Dr. Fleming presented three reasons for
terminating his debarment: (1) that he was effectively debarred in the
period between when he was convicted of the two felony offenses on
which his debarment was based and when FDA finalized his debarment; (2)
that he has taken training courses related to billing and ethics; and
(3) that he has taken steps to prevent future mistakes in billing and
collecting data.
    In proposing to deny Dr. Fleming's application to terminate his
debarment, ORA weighed the seriousness and nature of the offenses that
led to his debarment, including his culpability, against his statements
regarding other mitigating factors. After accounting for his assertions
that he had effectively been debarred since his original convictions,
ORA found that Dr. Fleming had not established that terminating his
debarment would serve the interests of justice or adequately protect
the integrity of the drug approval process. In his request for a
hearing on ORA's proposal, Dr. Fleming repeats some of the arguments
from his application for termination of debarment and provides some
additional context related to his own views on drug regulation, the
criminal justice system, and other ethical considerations. He further
clarifies some of the corrective actions he has implemented with
respect to patient billing.
    As a preliminary matter, the Chief Scientist notes Dr. Fleming's
request in his application for termination of debarment that FDA
consider the time starting from when he was convicted in 2009 as ``time
served.'' Dr. Fleming contended that, because he was convicted in 2009,
``the effective period of debarment has been 12+ years.'' While Dr.
Fleming does not renew this argument in his request for a hearing on
ORA's proposal, the timing of when he was convicted, when ORA proposed
his debarment, and when FDA finalized his debarment is not in dispute.
Notwithstanding his arguments to the contrary, FDA did not debar Dr.
Fleming until the Agency issued the final order debarring him in
September 2018. Neither his convictions nor ORA's proposal to debar him
started his debarment period pursuant to the Agency's authority under
section 306(b)(2)(B)(ii)(I) of the FD&C Act. He thus cannot now argue
that his ultimate debarment in September 2018 had any effect whatsoever
on him before that time. The Chief Scientist therefore agrees with ORA
that terminating his debarment on that basis would not serve the
interests of justice or adequately protect the integrity of the drug
approval process.
    The Chief Scientist further agrees with ORA that Dr. Fleming has
not shown that terminating his debarment would serve the interests of
justice or adequately protect the drug approval process--even in light
of the additional assertions and arguments proffered in support of his
hearing request on ORA's proposal. Both offenses underlying his
debarment are felony fraud convictions related to the regulation of
drugs. As noted in ORA's proposal to deny Dr. Fleming's application for
termination, the pattern of fraudulent conduct on which his convictions
were based calls into question his ability to comply with the FD&C Act
and indicates that he poses a threat to the drug approval process if he
were allowed to participate in it. In light of the conduct underlying
the convictions on which Dr. Fleming's debarment was based, his
assertions that he has taken some courses and adopted corrective
measures relative to billing patients and collecting data do not come
close to showing that terminating his debarment would serve the
interests of justice and adequately protect the drug approval process
in the sense contemplated by section 306(d)(3)(B)(ii). Dr. Fleming has
thus presented no material factual dispute for a hearing on ORA's
proposal to deny the application to terminate his debarment.

III. Conclusion

    Therefore, the Chief Scientist, under authority delegated to her,
denies Dr. Fleming's application for termination of debarment under
section 306(d) of the FD&C Act. A hearing on this request is not
necessary because there are no genuine and substantial issues of fact
(see Sec.  12.24(b)).
    Any person with an approved or pending drug product application who
knowingly uses the services of Dr. Fleming, in any capacity during his
period of debarment, will be subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Fleming
provides services in any capacity to a person with an approved or
pending drug product application, he will be subject to civil money
penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will
not accept or review any abbreviated new drug applications submitted by
or with the assistance of Dr. Fleming during his period of debarment
(section 306(c)(1)(B) of the FD&C Act).

    Dated: February 22, 2023.
Namandj[eacute] N. Bumpus,
Chief Scientist.
[FR Doc. 2023-04003 Filed 2-27-23; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 23, 2008 (Volume 73, Number 185)]
[Proposed Rules]
[Page 54747-54749]
[DOCID:fr23se08-28]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0150; Directorate Identifier 2007-NM-325-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 767-200, -300, and -400ER
Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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

SUMMARY: The FAA is revising an earlier NPRM for an airworthiness
directive (AD) that applies to certain Boeing Model 767 series
airplanes. The original NPRM would have superseded an existing AD that
currently requires a one-time inspection for missing, damaged, or
incorrectly installed parts in the separation link assembly on the
deployment bar of the emergency escape system on the entry or service
door, and installation of new parts if necessary. The original NPRM
proposed to require replacing the separation link assembly on the
applicable entry and service doors with an improved separation link
assembly, and related investigative and corrective actions if
necessary. The original NPRM also removed certain airplanes from the
applicability. The original NPRM resulted from reports that entry and
service doors did not open fully during deployment of emergency escape
slides, and additional reports of missing snap rings. This action
revises the original NPRM by adding a new inspection for discrepancies
of the unloaded spring dimensions in the separation link assembly, and
corrective actions if necessary. We are proposing this supplemental
NPRM to prevent failure of an entry or service door to open fully in
the event of an emergency evacuation, which could impede exit from the
airplane. This condition could result in injury to passengers or
crewmembers.

DATES: We must receive comments on this supplemental NPRM by October
20, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Keith Ladderud, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0150;
Directorate Identifier 2007-NM-325-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We proposed to amend part 39 of the Federal Aviation Regulations
(14 CFR part 39) with a notice of proposed rulemaking (NPRM) for an AD
(the ``original NPRM'') to supersede AD 2001-26-19, amendment 39-12585
(67 FR 265, January 3, 2002). The original NPRM applied to certain
Boeing Model 767 series airplanes. The original NPRM was published in
the Federal Register on February 11, 2008 (73 FR 7690). The original
NPRM proposed to require replacing the separation link assembly on the
applicable entry and service doors with an improved separation link
assembly, and related investigative and corrective actions if
necessary.

Actions Since Issuance of Original NPRM

    Since we issued the original NPRM, Boeing has issued Boeing Special
Attention Service Bulletin 767-25-0428, Revision 1, dated May 8, 2008
(we referred to the original service bulletin as the appropriate source
of information for accomplishing the actions). Revision 1 of the
service bulletin adds procedures for inspecting unloaded spring
dimensions in the separation link assembly for discrepancies (any nicks
or scrapes and subsequent breakage or other permanent deformation such
as bent tangs; out of tolerance cap screw) using the procedures
specified in the component maintenance manual, and replacing any
discrepant spring with a new spring. The service bulletin also adds new
torque values for the cap screw. Accomplishing the actions specified in
the service information is intended to adequately address the unsafe
condition.

Comments

    We have considered the following comments on the original NPRM.

Request for Changes to the Preamble of the Original NPRM

    Boeing provided the following comments to the original NPRM:
     Boeing asks that the sentence ``This proposed AD would
also remove certain airplanes from the applicability,'' be removed from
the SUMMARY section of the original NPRM. Boeing states that it is
unclear where or how certain airplanes have been removed from the
applicability since the initial release of the service bulletin.
     Boeing asks that the sentence ``We have also removed Model
767-300F airplanes * * *'' be removed from the ``Actions Since Existing
AD Was Issued'' section of the original NPRM. Boeing states that the
separation links are not part of the Model 767 Freighter; therefore,
freighters are not listed in the referenced service bulletin. Boeing
adds that they should not be listed in the AD

in the first place and should be removed.
     Boeing asks that the word ``existing'' be removed from the
sentence ``Therefore, we have determined that the existing separation
link assembly must be secured with a nut and washer * * *'' That
sentence is also in the ``Actions Since Existing AD Was Issued''
section of the original NPRM. Boeing states that the nut and washer
must be used with a new separation link assembly.
     Boeing asks that the second through the fifth sentences of
the ``Relevant Service Information'' section be removed. Boeing states
that the objective of the requested action in the service bulletin is
to bring the condition of the deployment bar assembly as near to the
``just manufactured'' condition as possible. Boeing notes that the
requested action is a reminder to perform normal, standard maintenance
practices and is not related to the root cause of the missing snap
rings.
    We partially agree with the Boeing comments.
    We do not agree to change the SUMMARY section to remove the
language which specified the subject airplanes were removed. That
language was specified in the NPRM because Model 767-300F airplanes
were included in the applicability of AD 2001-26-19, but would not be
included in the applicability of this supplemental NPRM.
    We acknowledge and agree that Boeing's suggested changes to the
other sections would further clarify the information specified in the
original NRPM. However, the other sections of the original NRPM do not
reappear in the supplemental NPRM.
    We have made no change to the supplemental NPRM in this regard.

FAA's Determination and Proposed Requirements of the Supplemental NPRM

    The changes discussed under ``Actions Since Issuance of Original
NPRM'' expand the scope of the original NPRM; therefore, we have
determined that it is necessary to reopen the comment period to provide
additional opportunity for public comment on this supplemental NPRM.

Costs of Compliance

    There are about 1,225 airplanes of the affected design in the
worldwide fleet. This proposed AD would affect about 355 airplanes of
U.S. registry. The new proposed actions would take up to about 6 work
hours per airplane, at an average labor rate of $80 per work hour.
Required parts would cost up to about $10,671 per airplane. Based on
these figures, the estimated cost of the new actions specified in this
proposed AD for U.S. operators is $3,958,605, or $11,151 per airplane.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this supplemental NPRM and placed it in the AD docket. See
the ADDRESSES section for a location to examine the regulatory
evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-12585 (67 FR 265, January 3, 2002) and adding the
following new airworthiness directive (AD):

Boeing: Docket No. FAA-2008-0150; Directorate Identifier 2007-NM-
325-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by October
20, 2008.

Affected ADs

    (b) This AD supersedes AD 2001-26-19.

Applicability

    (c) This AD applies to Boeing Model 767-200, -300, and -400ER
series airplanes, certificated in any category, as identified in
Boeing Special Attention Service Bulletin 767-25-0428, dated August
23, 2007.

Unsafe Condition

    (d) This AD results from reports that entry and service doors
did not open fully during deployment of emergency escape slides, and
additional reports of missing snap rings. We are issuing this AD to
prevent failure of an entry or service door to open fully in the
event of an emergency evacuation, which could impede exit from the
airplane. This condition could result in injury to passengers or
crewmembers.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Replacement

    (f) Within 48 months after the effective date of this AD,
replace the separation link assembly on the deployment bar of the
emergency escape system on all the applicable entry and service
doors with an improved separation link assembly, and do all the
applicable related investigative and corrective actions before
further flight, by accomplishing all of the applicable actions
specified in the Accomplishment Instructions of Boeing Special
Attention Service Bulletin 767-25-0428, dated August 23, 2007, or
Revision 1, dated May 8, 2008. After the effective date of this AD
only Revision 1 of the service bulletin may be used.

Alternative Methods of Compliance (AMOCs)

    (g)(1) The Manager, Seattle Aircraft Certification Office, FAA,
has the authority to approve AMOCs for this AD, if requested in

accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

    Issued in Renton, Washington, on September 11, 2008.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-22220 Filed 9-22-08; 8:45 am]

BILLING CODE 4910-13-P


From: Walter, William F CAR<EMAIL_ADDRESS>
Sent: Wednesday, August 08, 2007 4:55 PM

To: Gelmann, Elyssa

Subject: RE: R-410A component costs

Here is what I can tell you.

The numbers are directionally correct. However, the HP number would
typically be higher than the Residential AC number because more
components must be changed when transitioning to R-410A (Accumulator,
filter driers, 4 way valve, indoor coil). The Residential AC number is
in the ballpark. The HP number is probably low by $15-20. The PTAC
should be considered separately from the HP. I don't have any
information on dehumidifiers or room air conditioners.

From: Gelmann, Elyssa<EMAIL_ADDRESS>
Sent: Wednesday, August 08, 2007 2:41 PM

To: Walter, William F CAR

Subject: RE: R-410A component costs

Mr. Walter,

Our client needs the results of our cost analysis by Friday morning.
 As such, I would greatly appreciate it if you could send me any
information you are able to gather by midday tomorrow.  Even a general
opinion on whether the numbers I provided seem reasonable would be
extremely helpful.  I truly appreciate all of your help, and I
apologize for the rush.

Thanks,

Elyssa

From: Gelmann, Elyssa

Sent: Tuesday, August 07, 2007 1:58 PM

To: 'Walter, William F CAR'

Subject: RE: R-410A component costs

Mr. Walter,

Depending on the response, the information will be used either to
support our current numbers or will be averaged with data from other
sources to develop new estimates.  Numbers provided will be used only
indirectly (i.e., as part of an average).  Any information provided
will be considered confidential business information (CBI), and at no
point will your company’s name be used.  The R-22 to R-410A
transition analysis that the information will feed into may end up on
EPA’s public docket.  Please let me know if you need any more
information.

Elyssa

From: Walter, William F CAR<EMAIL_ADDRESS>
Sent: Tuesday, August 07, 2007 1:43 PM

To: Gelmann, Elyssa

Subject: RE: R-410A component costs

Before I can get anyone to respond, I am going to need additional
information on where this information will be used and what is being
done to protect proprietary information.

From: Gelmann, Elyssa<EMAIL_ADDRESS>
Sent: Friday, August 03, 2007 4:28 PM

To<EMAIL_ADDRESS>
Subject: R-410A component costs

Dear Mr. Walter,

Thank you for speaking with me earlier today about my question regarding
the increase in component costs when switching from R-22 to R-410A in
pre-charged appliances.  I greatly appreciate your offer to forward my
question to the applicable people at Carrier.  The reply is time
sensitive, so if it is possible to have any responses by mid-next week,
that would be ideal.  The question is as follows:

As part of an analysis to determine the total costs of transitioning
from R-22 to R-410A in pre-charged AC and refrigeration appliances,
including dehumidifiers, window air conditioners, residential air
conditioners, heat pumps and packaged terminal air-conditioners
(HP/PTAC), we are trying to quantify the cost change for the components
that need to be modified to accommodate the new refrigerant (i.e.,
thicker walled tubing to handle the higher pressure).  We are
specifically looking at modifications that are made to accommodate the
new refrigerant and not those that are implemented to increase
efficiency or improve other features.  Our estimates are provided in
the table below.  Please provide your reactions to these numbers –
are they in the correct range?  Too high?  Too low?  If you have more
accurate estimates, please provide those as well.

Type of Unit	Component cost increase for the use of R-410A

	Dehumidifiers	$3.00

	Window units	$7.00

	Residential 	$45.00

	HP/PTAC	$43.00

Thank you very much for your help!

Elyssa

_________________________________________________

Elyssa Gelmann

ICF International

1725 Eye St, NW

Suite 1000

Washington, DC 20006

Ph:<PHONE_NUMBER>

F:<PHONE_NUMBER>


[Federal Register: January 23, 2009 (Volume 74, Number 14)]
[Notices]
[Page 4279-4280]
[DOCID:fr23ja09-118]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twelfth Meeting--Special Committee 215--Aeronautical Mobile
Satellite (Route) Services, Next Generation Satellite Services and
Equipment

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 215, Aeronautical Mobile
Satellite (Route) Services, Next Generation Satellite Services and
Equipment.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 215, Aeronautical Mobile Satellite
(Route) Services, Next Generation Satellite Services and Equipment.

DATES: The meeting will be held February 17, 2009, 9 a.m. to 5 p.m. and
February 18, 2009, 9 a.m. to 12 noon.

ADDRESSES: RTCA Headquarters, 1828 L Street, NW., Washington, DC 20036;
USA, Tel: + 1<PHONE_NUMBER>, Fax: + 1<PHONE_NUMBER>, http://www.rtca.org.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax (202)
833-9434; Web site http://www.rtca.org for directions. For additional
details contact: Kelly O'Keefe, Tel: + 1<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
    Note: Dress is business casual.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a Special Committee 215 meeting. The agenda will
include:

February 17 (continued February 18 as necessary)

     Opening Plenary Session (Greetings, Introductions,
Administrative Remarks).
     Review and Approval of Agenda for 12th Plenary.
     Review and Approval of 11th Meeting Summary (RTCA Paper
No. 004-09/SC215-038).
     DO-262 Normative Appendix.
     Program Management Committee (PMC) Approval of Final
Draft.

     DO-270 Normative Appendix.
     Review and Resolution of Final Review and Comment (FRAC)
responses.
     Approval of DO-270 Normative Appendix for submission to
PMC.
     Closing Plenary (Any Other Business, Review of Next
Plenary Meeting Dates (if required), Adjourn).
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on January 13, 2009.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. E9-1342 Filed 1-22-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Notices]
[Pages 8296-8297]
[FR Doc No: 2020-02871]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2494]

Peripheral Vascular Atherectomy Devices--Premarket Notification
Submissions; Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Peripheral Vascular
Atherectomy Devices--Premarket Notification Submissions.'' This
guidance provides recommendations for premarket submissions for a new
or modified peripheral vascular atherectomy device.

DATES: The announcement of the guidance is published in the Federal
Register on February 13, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include Docket No. FDA-
2018-D-2494 for ``Peripheral Vascular Atherectomy Devices--Premarket
Notification [510(k)] Submissions.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Peripheral Vascular Atherectomy Devices--Premarket Notification
[510(k)] Submissions'' to the Office of the Center Director, Guidance
and Policy Development, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Jhumur Banik, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2223, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Atherectomy is an interventional procedure performed to remove
atherosclerotic plaque from diseased arteries. FDA has developed this
guidance for members of industry who submit and FDA staff who review
premarket submissions for atherectomy devices used in the peripheral
vasculature. This guidance is intended to provide recommendations for
information to include in premarket notifications (510(k)) for
peripheral vascular atherectomy devices (e.g., descriptive
characteristics, labeling, biocompatibility, sterility, non-clinical,
animal, and clinical performance testing).
    FDA considered comments received on the draft guidance that
appeared in the Federal Register of July 27, 2018 (83 FR 35658). FDA
revised the guidance as appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Peripheral

Vascular Atherectomy Devices--Premarket Notification [510(k)]
Submissions.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Peripheral Vascular
Atherectomy Devices--Premarket Notification [510(k)] Submissions'' may
send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document. Please use the document number 16013
and complete title to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. 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. 3501-3521). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
21 CFR part/section or guidance           Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket Notification.       0910-0120
812............................  Investigational Device        0910-0078
                                  Exemption.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
807, subparts A through D......  Electronic Submission         0910-0625
                                  of Medical Device
                                  Registration and
                                  Listing.
50, 56.........................  Protection of Human           0910-0755
                                  Subjects: Informed
                                  Consent; Institutional
                                  Review Boards.
56.............................  Institutional Review          0910-0130
                                  Boards.
58.............................  Good Laboratory               0910-0119
                                  Practice (GLP)
                                  Regulations for
                                  Nonclinical Laboratory
                                  Studies.
801.150(a)(2) and (e)..........  Agreement for Shipments       0910-0131
                                  of Devices for
                                  Sterilization.
``Requests for Feedback on       Q-submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff ''.
------------------------------------------------------------------------

    Dated: February 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02871 Filed 2-12-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 95 (Tuesday, May 17, 2011)]
[Rules and Regulations]
[Pages 28309-28311]
[FR Doc No: 2011-12011]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0316]

Drawbridge Operation Regulation; Sturgeon Bay Ship Canal,
Sturgeon Bay, WI

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations; request for
comments.

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

SUMMARY: Commander, Ninth Coast Guard District, has issued a temporary
deviation from the regulation governing the operation of the Michigan
Street and Maple-Oregon Street Bridges across the Sturgeon Bay Ship
Canal, at miles 4.3 and 4.17, respectively, both in Sturgeon Bay,
Wisconsin. This deviation will test a change to the drawbridge
operation schedules during the peak tourist and navigation seasons to
provide for the efficient movement of vehicular traffic and the safety
of navigation on the waterway. This deviation will allow scheduled
openings for recreational vessels and openings on signal for commercial
vessels.

DATES: This deviation is effective from noon on May 27, 2011 through
noon on September 16, 2011. Comments and related material must be
received by the Coast Guard by September 16, 2011.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0316 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 proposed
rule, call or e-mail Mr. Lee D. Soule, Bridge Management Specialist;
telephone<PHONE_NUMBER>, facsimile<PHONE_NUMBER>, or e-mail
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. 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
rulemaking (USCG-2011-0316), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (http://www.regulations.gov), or by fax, mail or hand delivery,
but please use only one of these means. If you submit a comment online
via http://www.regulations.gov, it will be considered received by the
Coast Guard when you successfully transmit the comment. If you fax,
hand deliver, or mail your comment, it will be considered as having
been received by the Coast Guard when it is received at the Docket
Management Facility. We recommend that you include your name and a
mailing address, an e-mail address, or a phone 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,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Keyword'' box insert ``USCG-2011-0316,''
click ``Search,'' and then click on the balloon shape in the
``Actions'' column. 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
and may change the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2011-0316'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit 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 notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before September 1, 2011 by using one of the four
methods specified under ADDRESSES. Please explain why one would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

Basis and Purpose

    The Sturgeon Bay Ship Canal is approximately 8.6 miles long and
provides a navigable connection between Lake Michigan and Green Bay.
The area experiences a significant increase in vehicular and vessel
traffic during the peak tourist and navigation season, between
approximately Memorial Day and Labor Day each year.
    There are a total of three highway drawbridges across the waterway.
The Michigan Street Bridge provides unlimited vertical clearance in the
open position and 14 feet in the closed position. Maple-Oregon Bridge
provides unlimited vertical clearance in the open position and 25 feet
in the closed position. Bay View Bridge also provides unlimited
vertical clearance in the open position and 42 feet in the closed
position. Both Michigan Street and Maple-Oregon Bridges serve the
downtown Sturgeon Bay area and are located approximately 750-feet apart
on the canal.
    A final rule, CGD9-05-080, was published in the October 24, 2005
edition of the Federal Register (70 FR 61380) to allow:
    (1) The draw of the Michigan Street Bridge to open for recreational
vessels on the hour 24 hours a day from March 15 through December 31
and on signal if at least 12 hours notice is given from January 1
through March 14 The final rule also included a requirement to open at
any time if 20 or more vessels gathered or vessels are seeking shelter
from severe weather; and
    (2) The draw of the Bayview (SR42/57) Bridge, mile 3.3 Sturgeon Bay
to open on signal from March 15 through November 30; and on signal if
at least 12 hours notice is given from December 31 through March 14.
    A temporary final rule, USCG-2009-0385, was published in the June
5, 2009 edition of the Federal Register (74 FR 26954), effective from
June 5, 2009 to November 15, 2010 that essentially shifted the March 15
through December 31 one bridge opening per hour at Michigan Street
Bridge to the Maple-Oregon Bridge while the rehabilitation of Michigan
Street was completed and the bridge was kept in the open-to-navigation
position.
    Both drawbridges are now operational for vehicular and vessel
traffic and the one opening per hour schedule for Michigan Street
Bridge is reinstated while Maple-Oregon Bridge opens at any time for
vessels. With both Michigan Street and Maple-Oregon Bridges operational
the one opening per hour schedule for Michigan Street is considered
restrictive for vessels, and could potentially create an unsafe
condition for vessel traffic that may be between the two closely
located drawbridges while waiting for bridge openings. The Wisconsin
Department of Transportation (WDOT) requested scheduled drawbridge
openings for both Michigan Street and Maple-Oregon Bridges so vehicular
traffic congestion would not develop on downtown Sturgeon Bay streets
due to unscheduled bridge openings. Commander, Ninth Coast Guard
District, evaluated that request, as well as the need to provide
efficient and safe bridge openings for vessels, and along with WDOT and
local stakeholders developed this temporary test drawbridge schedule
for the 2011 peak tourist and navigation season. Throughout the
temporary drawbridge schedule WDOT will post signs at both drawbridges
and collect vehicular traffic and bridge opening data. Public comments
will also be accepted throughout the test period.

Temporary Drawbridge Schedule

    From noon on May 27, 2011 through noon on September 16, 2011, 24-
hours per day and 7-days per week, the Michigan Street Bridge at mile
4.3 over the Sturgeon Bay Ship Canal will open on the hour and half-
hour for recreational vessels, if needed. The Maple-Oregon Bridge at
mile 4.17 will open fifteen-minutes before the hour and fifteen minutes
after the hour for recreational vessels, if needed. Both

bridges will open on signal for all commercial vessels, federal, state,
and local government vessels used for public safety, vessels in
distress, or seeking shelter from severe weather. If at any time more
than 10 vessels accumulate at either bridge the bridge will open and
allow all vessel traffic to clear the bridge. Vessels that may pass
under the bridges without an opening may do so at anytime. In
accordance with 33 CFR 117.35(e), the drawbridges must return to their
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: April 22, 2011.
Scot M. Striffler,
Bridge Program Manager, Ninth Coast Guard District.
[FR Doc. 2011-12011 Filed 5-16-11; 8:45 am]
BILLING CODE 9110-04-P