[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14445-14447]
[FR Doc No: 2021-05371]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-0340]

Determination of Regulatory Review Period for Purposes of Patent
Extension; HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for HINTERMANN SERIES H3 TOTAL
ANKLE REPLACEMENT SYSTEM and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that medical device.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by May 17, 2021.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by September 13, 2021. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 17, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 17, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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 the Docket No.
FDA-2020-E-0340 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; HINTERMANN SERIES H3 TOTAL ANKLE
REPLACEMENT SYSTEM.'' Received comments, those filed in a timely manner
(see ADDRESSES), 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 Sec.
10.20 (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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device HINTERMANN SERIES
H3 TOTAL ANKLE REPLACEMENT SYSTEM. HINTERMANN SERIES H3 TOTAL ANKLE
REPLACEMENT SYSTEM is indicated for use as a non-cemented implant to
replace a painful arthritic ankle joint due to primary osteoarthritis,
post-traumatic osteoarthritis, or arthritis secondary to inflammatory
disease (e.g., rheumatoid arthritis, hemochromatosis, etc.). The device
system is for prescription use. Subsequent to this approval, the USPTO
received a patent term restoration application for HINTERMANN SERIES H3
TOTAL ANKLE REPLACEMENT SYSTEM (U.S. Patent No. 6,409,767) from
European Foot Platform, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated July 14, 2020, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT SYSTEM represented the
first permitted commercial marketing or use of the product. Thereafter,
the USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT SYSTEM is 4,676 days. Of
this time, 3,661 days occurred during the testing phase of the
regulatory review period, while 1,015 days occurred during the approval
phase. These periods of time were derived from the following dates:
    1. The date on which the device is first used with human subjects
as part of a clinical investigation to be filed with FDA to secure
premarket approval of the device: August 17, 2006. FDA has verified the
applicant's claim that the date on which the device is first used with
human subjects as part of a clinical investigation to be filed with FDA
to secure premarket approval of the device was August 17, 2006.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): August
24, 2016. FDA has verified the applicant's claim that the premarket
approval application (PMA) for HINTERMANN SERIES H3 TOTAL ANKLE
REPLACEMENT SYSTEM (PMA 160036) was initially submitted August 24,
2016.
    3. The date the application was approved: June 4, 2019. FDA has
verified the applicant's claim that PMA 160036 was approved on June 4,
2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,825 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05371 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 19, 2007 (Volume 72, Number 181)]
[Notices]
[Page 53610-53612]
[DOCID:fr19se07-128]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 27968; 812-13388]

Hercules Technology Growth Capital, Inc.; Notice of Application

September 12, 2007.
AGENCY: Securities and Exchange Commission (The ``Commission'').

ACTION: Notice of an application for an order under section 61(a)(3)(B)
of the Investment Company Act of 1940 (the ``Act'').

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SUMMARY OF APPLICATION: Applicant, Hercules Technology Growth Capital,
Inc. (``HTGC''), requests an order that would approve the proposal to
issue stock options to directors who are not officers or employees of
HTGC (``Non-employee Directors'') under HTGC's amended and restated
2006 Non-employee Director Plan (the ``Amended and Restated 2006
Plan''). The requested order would supersede a prior order issued to
HTGC under section 61(a)(3)(B) of the Act (the ``HTGC Options
Order'').\1\
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    \1\ Hercules Technology Growth Capital, Inc., Investment Company
Act release Nos. 27668 (Jan. 19, 2007) (notice) and 27699 (Feb. 15,
2007) (order).

FILING DATES: The application was filed on May 24, 2007 and amended on
September 10, 2007. HTGC has agreed to file an amendment during the
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notice period, the substance of which is reflected in this notice.

Hearing or Notification of Hearing:  An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicant with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on October 9, 2007, and should be accompanied by proof of service
on applicant, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F.
Street, NE., Washington, DC 20549-1090. HTGC, c/o Manuel A. Henriquez,
Chairman of the Board, President and Chief Executive Officer, 400
Hamilton Avenue, Suite 310, Palo Alto, California 94301.

FOR FURTHER INFORMATION CONTACT: Laura J. Riegel, Senior Counsel, at
(202) 551-6873, or Nadya B. Roytblat, Assistant Director, at (202) 551-
6821 (Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application is available for a fee at the
Commission's Public Reference Branch, 100 F Street, NE., Washington, DC
20549-0102 (tel.<PHONE_NUMBER>).

Applicant's Representations

    1. HTGC, a Maryland corporation, is a business development company
(``BDC'') within the meaning of section 2(a)(48) of the Act.\2\ HTGC is
a specialty finance company that provides debt and equity growth
capital to technology-related and life-science companies at all stages
of development. HTGC's business and affairs are managed under the
direction of its board of directors (``Board''). HTGC does not have an
external investment adviser within the meaning of section 2(a)(20) of
the Act.
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    \2\ Section 2(a)(48) generally defines a BDC to be any closed-
end investment company that operates for the purpose of making
investments in securities described in sections 55(a)(1) through
55(a)(3) of the Act and makes available significant managerial
assistance with respect to the issuers of such securities.
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    2. HTGC requests an order under section 61(a)(3)(B) of the Act that
would approve the proposal under the Amended and Restated 2006 Plan to

issue stock options to Non-employee Directors to purchase shares of
HTGC's common stock, $.001 par value per share (``Common Stock''). The
requested order would supersede the HTGC Options Order approving the
issuance of stock options to Non-employee Directors to purchase Common
Stock under HTGC's 2006 Non-employee Director Plan (the ``Original 2006
Plan'').\3\
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    \3\ HTGC has not issued any options to Non-employee Directors
under the Original 2006 Plan. At a meeting held on May 17, 2007, the
Board voted to approve the suspension of the Original 2006 Plan and
the grant of any options under the Original 2006 Plan.
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    3. HTGC currently has a four member Board, one of whom is
considered to be an ``interested person'' of HTGC within the meaning of
section 2(a)(19) of the Act and three of whom are not interested
persons (``Non-interested Directors''). HTGC currently has three Non-
employee Directors.\4\ The Non-employee Directors are all Non-
interested Directors, but it is possible that HTGC may have Non-
employee Directors in the future who are interested persons of HTGC.\5\
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    \4\ Because HTGC has a staggered Board, each director on the
Board is elected to a three year term subject to reelection only
every three years.
    \5\ Each Non-employee Director receives an annual fee of
$50,000, $1,500 for each committee meeting attended, and
reimbursement of reasonable out-of-pocket expenses incurred in
attending Board meetings. Each Non-employee Director who serves as
chairperson of a Board committee receives an additional $15,000 per
year.
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    4. The Board approved the Amended and Restated 2006 Plan on March
7, 2007 and amendments to the Amended and Restated 2006 Plan by
unanimous written consent on July 20, 2007.\6\ At the annual meeting of
stockholders of HTGC held on June 21, 2007, stockholders approved the
Amended and Restated 2006 Plan and the separate 2007 amendment and
restatement of HTGC's amended and restated 2004 Equity Incentive Plan
(such plan, before both amendments and restatements, the ``Original
2004 Plan''; as first amended and restated, the ``First Amended and
Restated 2004 Plan''; and as further amended and restated in 2007, the
``Second Amended and Restated 2004 Plan''). Participants under the
Second Amended and Restated 2004 Plan are limited to employees of HTGC
and do not include Non-employee Directors.
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    \6\ The Board determined that its amendments to the Amended and
Restated 2006 Plan complied with that section of the Amended and
Restated 2006 Plan authorizing plan amendments and did not
necessitate a stockholder vote pursuant to the provisions of the Act
and the rules promulgated thereunder.
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    5. A Commission order permits HTGC to issue shares of Common Stock
that, at the time of issuance, are subject to certain forfeiture
restrictions, and thus are restricted as to their transferability until
such forfeiture restrictions have lapsed (the ``Restricted Stock'') to
Non-employee Directors under the Amended and Restated 2006 Plan and
employees of HTGC and employees of its wholly-owned consolidated
subsidiaries under the Second Amended and Restated 2004 Plan (``HTGC
Restricted Stock Order'').\7\ In light of the HTGC Restricted Stock
Order, HTGC believes that it will no longer need to issue options to
purchase as many shares of Common Stock as it did under the Original
2006 Plan to adequately compensate Non-employee Directors. As compared
to the Original 2006 Plan, the Amended and Restated 2006 Plan would
reduce the number of options granted to Non-employee Directors, change
the timeframe within which such options are granted, and change the
vesting provisions of such options.
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    \7\ Hercules Technology Growth Capital, Inc., Investment Company
Act Release Nos. 27815 (May 2, 2007) (notice) and 27838 (May 23,
2007) (order).
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    6. Under the Amended and Restated 2006 Plan, a maximum of 1,000,000
shares of Common Stock, in the aggregate, may be issued to Non-employee
Directors and 40,000 shares of Common Stock may be issued to any Non-
employee Director in any calendar year. Each individual initially
elected to the Board as a Non-employee Director after the date on which
the Commission issues an order on the application (the ``Order Date'')
will automatically be granted options to purchase 10,000 shares of
Common Stock (the ``Initial Grants''). The options issued under the
Initial Grants will vest as to one-half of the 10,000 shares of Common
Stock on each of the first two anniversaries of the date of grant. Each
Non-employee Director automatically will be granted options to purchase
15,000 shares of Common Stock on the date of such Non-employee
Director's reelection to the Board (the ``Periodic Grants''). The
options issued under the Periodic Grants will vest as to one-third of
the 15,000 shares of Common Stock on each of the three anniversaries of
the date of grant. Non-employee Directors who hold office on the Order
Date will be granted options for a number of shares of Common Stock
equal to the product of (x) the number of years remaining in their
then-current term divided by three and (y) 15,000. These options will
vest as to 5,000 shares of Common Stock on each anniversary of the date
of grant over the remainder of such Non-employee Director's term in
office.
    7. Under the terms of the Amended and Restated 2006 Plan, the
exercise price of an option will not be less than the current market
value of, or if no such market value exists, the current net asset
value per share of, Common Stock on the date of the issuance of the
option.\8\ Options granted under the Amended and Restated 2006 Plan
will expire ten years from the date of grant and may not be transferred
except for disposition by gift, will or intestacy.
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    \8\ Under the Amended and Restated 2006 Plan, ``current market
value'' is the closing price of the Common Stock on the NASDAQ
Global Market (or if different, on the exchange where the Common
Stock is traded) on the date the option is granted.
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    8. As of July 31, 2007, HTGC had issued 6,668 shares of Restricted
Stock to Non-employee Directors under the Amended and Restated 2006
Plan, had outstanding options to purchase 2,782,513 shares of Common
Stock and had outstanding warrants to purchase 382,629 shares of Common
Stock. As of that date, all outstanding options to purchase Common
Stock consisted entirely of options issued to directors, officers, and
employees of HTGC under the Original 2004 Plan and the First Amended
and Restated 2004 Plan.\9\ As of July 31, 2007, of the outstanding
warrants to purchase 382,629 shares of Common Stock, warrants issued to
officers and employees of HTGC under the Original 2004 Plan to purchase
10,693 shares of Common Stock were outstanding. The other warrants
outstanding as of that date were issued to directors, officers, and
employees of HTGC under a warrant agreement dated June 22, 2004 by and
between HTGC and American Stock Transfer & Trust Company, as warrant
agent (the ``Warrant Agreement''). HTGC has no outstanding warrants and
options to purchase its voting securities, other than the warrants and
options issued under the Original 2004 Plan, the Warrant Agreement, and
the First Amended and Restated 2004 Plan.
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    \9\ As of July 31, 2007, HTGC had outstanding options issued to
directors, officers, and employees of HTGC under the Original 2004
Plan and the First Amended and Restated 2004 Plan to purchase
1,221,013 shares of Common Stock and 1,561,500 shares of Common
Stock, respectively.
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    9. As of July 31, 2007, HTGC had outstanding 32,414,178 shares of
Common Stock.\10\ As of that date, the amount of voting securities
issued as Restricted Stock under the Amended and Restated 2006 Plan and
that would result from the exercise of all outstanding warrants and
options would be 3,171,180 shares of Common Stock,

or approximately 9.78% of HTGC's outstanding voting securities. As of
July 31, 2007, the amount of voting securities issued as Restricted
Stock under the Amended and Restated 2006 Plan and that would result
from the exercise of all outstanding warrants and options issued to
directors, officers, and employees of HTGC under the Original 2004 Plan
and the First Amended and Restated 2004 Plan would be 2,799,874 shares
of Common Stock, or approximately 8.66% of HTGC's outstanding voting
securities.
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    \10\ The outstanding 32,414,178 shares of Common Stock, as of
July 31, 2007, include the 6,668 shares of Restricted Stock issued
under the Amended and Restated 2006 Plan. The Common Stock, of which
the Restricted Stock is a particular type, constitutes the only
voting security of HTGC currently outstanding.
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Applicant's Legal Analysis

    1. Section 63(3) of the Act permits a BDC to sell its common stock
at a price below current net asset value upon the exercise of any
option issued in accordance with section 61(a)(3) of the Act. Section
61(a)(3)(B) of the Act provides, in pertinent part, that a BDC may
issue to its non-employee directors options to purchase its voting
securities pursuant to an executive compensation plan, provided that:
(a) The options expire by their terms within ten years; (b) the
exercise price of the options is not less than the current market value
of the underlying securities at the date of the issuance of the
options, or if no market exists, the current net asset value of the
voting securities; (c) the proposal to issue the options is authorized
by the BDC's shareholders, and is approved by order of the Commission
upon application; (d) the options are not transferable except for
disposition by gift, will or intestacy; (e) no investment adviser of
the BDC receives any compensation described in section 205(a)(1) of the
Investment Advisers Act of 1940, except to the extent permitted by
clause (b)(1) or (b)(2) of that section; and (f) the BDC does not have
a profit-sharing plan as described in section 57(n) of the Act.
    2. In addition, section 61(a)(3) of the Act provides that the
amount of the BDC's voting securities that would result from the
exercise of all outstanding warrants, options, and rights at the time
of issuance may not exceed 25% of the BDC's outstanding voting
securities, except that if the amount of voting securities that would
result from the exercise of all outstanding warrants, options, and
rights issued to the BDC's directors, officers, and employees pursuant
to an executive compensation plan would exceed 15% of the BDC's
outstanding voting securities, then the total amount of voting
securities that would result from the exercise of all outstanding
warrants, options, and rights at the time of issuance will not exceed
20% of the outstanding voting securities of the BDC.
    3. HTGC represents that the proposal to issue options to Non-
employee Directors under the Amended and Restated 2006 Plan meets all
of the requirements of section 61(a)(3) of the Act. HTGC states that
the Board, including the Non-employee Directors, actively oversees
HTGC's affairs and HTGC relies on the judgment and experience of the
Board. HTGC states that the Non-employee Directors provide advice on
financial and operational issues, credit and underwriting policies,
asset valuation, strategic direction, as well as serve on various
committees. HTGC states that the professional experiences and expertise
of the Non-employee Directors make them valuable resources for
management. HTGC states that the options that will be granted to the
Non-employee Directors under the Amended and Restated 2006 Plan will
provide significant incentives to the Non-employee Directors to remain
on the Board and to devote their best efforts to the success of HTGC's
business and the enhancement of stockholder value. HTGC states that the
options granted under the Amended and Restated 2006 Plan will provide a
means for the Non-employee Directors to increase their ownership
interests in HTGC, thereby ensuring close identification of their
interests with those of HTGC and its stockholders. HTGC asserts that by
providing incentives in the form of options under the Amended and
Restated 2006 Plan, HTGC would be better able to retain and attract
qualified persons to serve as Non-employee Directors.
    4. HTGC submits that the proposal to issue options to Non-employee
Directors to purchase Common Stock under the Amended and Restated 2006
Plan is fair and reasonable and does not involve overreaching of HTGC
or its stockholders. HTGC states that the amount of voting securities
issued as Restricted Stock under the Amended and Restated 2006 Plan and
that would result from the exercise of all outstanding options and
warrants issued to directors, officers and employees of HTGC under the
Original 2004 Plan and the First Amended and Restated 2004 Plan would
be 2,799,874 shares of Common Stock, or approximately 8.66% of HTGC's
outstanding voting securities as of July 31, 2007, which is below the
percentage limitations in the Act. In light of the above, HTGC asserts
that the granting of options pursuant to the Amended and Restated 2006
Plan will not have a substantial dilutive effect on the net asset value
of Common Stock.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-18388 Filed 9-18-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Notices]
[Page 59212]
[FR Doc No: 2016-20629]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-2458-000]

Emera Energy Services Subsidiary No. 14 LLC; Supplemental Notice
That Initial Market-Based Rate Filing Includes Request for Blanket
Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Emera Energy Services Subsidiary No. 14 LLC`s application for market-
based rate authority, with an accompanying rate tariff, noting that
such application includes a request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 12, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic 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
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: August 23, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-20629 Filed 8-26-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Notices]
[Pages 37837-37838]
[FR Doc No: 2014-15455]

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DEPARTMENT OF TRANSPORTATION

[Docket Number DOT-OST-2014-0112]

Agency Information Collection Activity; Notice of Request for
Approval To Collect New Information: Voluntary Near Miss Reporting in
Oil and Gas Operations on the Outer Continental Shelf

AGENCY: Bureau of Transportation Statistics (BTS), Office of the
Assistant Secretary for Research and Technology (OST-R), U.S.
Department of Transportation.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the requirements of section 3506(c)(2)(A)
of the Paperwork Reduction Act of 1995, this notice announces the
intention of the Bureau of Transportation Statistics to request the
Office of Management and Budget (OMB) to approve the following
information collection: Voluntary Near Miss Reporting in Oil and Gas
Operations on the Outer Continental Shelf (OCS). This data collection
effort supports a multi-year program focused on improving safety in the
OCS by collecting and analyzing data and information on near misses and
other unsafe occurrences in all oil and gas operations on the OCS. In
August 2013, the Bureau of Safety and Environmental Enforcement (BSEE)
and BTS signed an Interagency Agreement (IAA) to develop and implement
a voluntary program for confidential reporting of `near misses'
occurring on the OCS. BTS will analyze and aggregate information
provided under this program and publish reports that will provide BSEE,
the industry and all OCS stakeholders with essential information about
accident precursors and other hazards associated with OCS oil and gas
operations so that all stakeholders can use that information to reduce
safety and environmental hazards and continue building a more robust
OCS safety culture. This information collection is necessary to aid
BSEE, the oil and gas industry and other stakeholders in identifying
root causes of potentially unsafe events.

DATES: Written comments should be submitted by September 2, 2014.

ADDRESSES: To ensure that your comments are not entered more than once
into the docket, submit comments by only one of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically. Docket Number: DOT-OST-2014-0112.
     Mail: Docket Services, U.S. Department of Transportation,
1200 New Jersey Avenue SE., West Building, Ground Floor, Room W12-140,
Washington, DC 20590-0001.
     Hand Delivery: Deliver to mail address above between 9
a.m. and 5 p.m. EST, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

Identify all transmission with ``Docket Number DOT-OST-2014-0112'' at
the beginning of each page of the document.
    Instructions: All comments must include the agency name and docket
number for this notice. Paper comments should be submitted in
duplicate. The DMF is open for examination and copying, at the above
address from 9 a.m. to 5 p.m. EST, Monday through Friday, except
Federal holidays. If you wish to receive confirmation of receipt of
your written comments, please include a self-addressed, stamped
postcard with the following statement: ``Comments on Docket Number DOT-
OST-2014-0112.'' The Docket Clerk will date stamp the postcard prior to
returning it to you via the U.S. mail. Please note that all comments
received, including any personal information, will be posted and will
be publicly viewable, without change, at www.regulations.gov. You may
review DOT's complete Privacy Act Statement in the Federal Register
published on April 11, 2000 (Volume 65, Number 70; pages 19477-78) or
you may review the Privacy Act Statement at www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Demetra V. Collia, Bureau of
Transportation Statistics, Office of the Assistant Secretary for
Research and Technology, U.S. Department of Transportation, Office of
Advanced Studies, RTS-31, E324-302, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001; Phone No.<PHONE_NUMBER>; Fax No. (202) 366-
3383; email<EMAIL_ADDRESS>Office hours are from 8:30 a.m. to
5 p.m., EST, Monday through Friday, except Federal holidays.
    Data Confidentiality Provisions: The confidentiality of near miss
data submitted to BTS is protected under the BTS confidentiality
statute (49 U.S.C. Sec. 6307) and the Confidential Information
Protection and Statistical Efficiency Act (CIPSEA) of 2002 (Pub. L.
107-347, Title V). In accordance with these confidentiality statutes,
only statistical and non-identifying data will be made publicly
available by BTS through its reports. BTS will not release to BSEE or
any other public or private entity any information that might reveal
the identity of individuals or organizations mentioned in near miss
reports without explicit consent of the respondent and any other
affected entities.

SUPPLEMENTARY INFORMATION:

I. The Data Collection

    The Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35; as
amended) and 5 CFR part 1320 require each Federal agency to obtain OMB
approval to initiate an information collection activity. BTS is seeking
OMB approval for the following BTS information collection activity:
    Title: Voluntary Near Miss Reporting in Oil and Gas Operations on
the Outer Continental Shelf
    OMB Control Number: TBD.
    Type of Review: Approval of data collection.
    Respondents: Employees working in the oil and gas industry on the
OCS.
    Number of Potential Responses: Based on near miss reporting trends
in other industries, BTS expects to receive no more than two responses
per calendar day during the first three years of the program
(approximately 730 responses per year).
    Estimated Time per Response: not to exceed 60 minutes (this
includes estimated time for a follow up interview, if needed.)

    Frequency: Intermittent for three years. (Reports are submitted
when there is a qualifying event, i.e., when a near miss occurs in oil
and gas operations on the OCS.)
    Total Annual Burden: 730 hours.
    Abstract: Collecting transportation safety data, including data on
precursors to adverse events, is an important component of BTS's
responsibility to the transportation community and is authorized in
BTS' authorizing statute (49 U.S.C. 6302). To that end, BTS has entered
into an IAA with BSEE to establish and operate a voluntary,
confidential near miss data collection program. In 2013, the National
Commission on the BP Deepwater Horizon Oil Spill recommended, among
other things, that BSEE develop a system for reporting near miss events
in oil and gas operations on the OCS. BSEE evaluated various near miss
reporting systems that have proven successful in improving safety in
major industries (such as commercial airlines, railroads, and
firefighting programs) and identified BTS as an agency with experience
in developing and operating such systems to improve safety.
    It is estimated that the time for an individual respondent to
complete a near miss report and, if needed, participate in a brief
confidential interview will be no more than 60 minutes for a maximum
total burden of 730 hours (730 reports*60 minutes/60 = 720 hours).
Reports may be voluntarily submitted to BTS when there is a qualifying
event, i.e., when a near miss occurs in oil and gas operations on the
OCS. Potential respondents include employees of OCS oil and gas lessees
and operators and their contractors. It should be noted that not all of
the potential respondents will submit information at any given time and
some may submit multiple times.

II. Background

    Under the Outer Continental Shelf Lands Act (OCSLA), 43 U.S.C.
1331-1356a, the Secretary of the Interior (the Secretary) is authorized
to regulate oil and natural gas exploration, development, and
production operations on the OCS. The Secretary has assigned BSEE the
responsibility for offshore safety and environmental enforcement under
OCSLA (see 76 FR 64432, Oct. 18, 2011). The BSEE promotes safety,
protects the environment, and conserves offshore oil and gas resources
through regulatory oversight and enforcement, research activities,
public outreach, information sharing, and appropriate cooperation with
industry and other OCS stakeholders. BSEE's goals include building and
maintaining a culture of safety and risk reduction on the OCS.
    In 2013, the National Commission on the BP Deepwater Horizon Oil
Spill recommended, among other things, that BSEE develop a system for
near miss reporting for oil and gas operations on the OCS. BSEE has
decided to implement that recommendation through a system of voluntary
reporting of near miss information. BSEE has also decided to encourage
participation in that system by ensuring the confidentiality of such
reports, including the reporter's identities (if provided) and other
identifying information.
    BSEE evaluated various near miss reporting systems that have proven
successful in improving safety in major industries (such as commercial
airlines, railroads, and firefighting programs) and identified BTS as
an agency with experience in developing and operating such systems, on
a confidential basis, to improve safety. In August 2013, BSEE and BTS
signed an IAA to develop and implement a voluntary program for
confidential reporting of `near misses' occurring on the Outer
Continental Shelf (OCS).
    The goal of the voluntary near miss reporting system is to provide
BTS with essential information about accident precursors and other
hazards associated with OCS oil and gas operations. BTS will develop
and publish aggregate reports that BSEE, the industry and all OCS
stakeholders can use--in conjunction with incident reports and other
sources of information--to reduce safety and environmental risks and
continue building a more robust OCS safety culture.
    A near miss is an event and/or condition that could have resulted
in loss, or had the potential for additional safety, environmental or
other consequences, but did not result in an adverse event. This
adverse event was prevented only by a fortuitous break in the chain of
events and/or conditions. The potential loss could be human injury,
environmental damage, or negative business impact. Knowledge about a
near miss presents an opportunity to address unsafe work conditions,
prevent accidents, and improve safety and environmental protection in
the workplace. Near miss systems in other industry sectors have shown
that voluntary reporting of near misses to a confidential system can
become a tool to identify safety issues and help prevent accidents by
providing a cooperative, non-punitive environment to communicate safety
concerns.
    BTS will: Collect near miss reports voluntarily submitted by
employees and other respondents working on the OCS; conduct follow-up
interviews as needed, develop an analytical database using the reported
data and other pertinent information; conduct statistical analyses and
develop public reports; and protect the confidentiality of the near
miss reports in accordance with BTS' own statute and CIPSEA.
Accordingly, only statistical and non-sensitive information will be
made available through BTS' publications and reports. Those
publications and reports will potentially provide the industry, BSEE,
other OCS stakeholders, and the public with valuable information
regarding precursors to safety risks and contribute to research and
development of intervention programs aimed at preventing accidents and
fatalities in the OCS.
    Respondents who report a near miss event will be asked to fill out
a report and participate in a brief, confidential interview for further
clarification, as needed. Respondents will have the option to mail or
submit the report electronically to BTS. Respondents will be asked to
provide information such as: (1) Name and contact information
(optional); (2) time and location of the event; (3) a short description
of the event; (4) contributing factors to the reported near miss; and
(5) any other information that might be useful in determining a root
cause of such event.
    Some of the information collected through this voluntary initiative
will also help inform the continuing effort to work with oil and gas
companies and other entities that already collect offshore near miss
data.

III. Request for Public Comment

    BTS requests comments on any aspects of this information collection
request, including: (1) The accuracy of the estimated burden of 730
hours detailed in Section I; (2) ways to enhance the quality,
usefulness, and clarity of the collected information; and (3) ways to
minimize the collection burden without reducing the quality of the
information collected, including additional use of automated collection
techniques or other forms of information technology.

Patricia Hu,
Director, Bureau of Transportation Statistics, Office of the Assistant
Secretary for Research and Technology.
[FR Doc. 2014-15455 Filed 7-1-14; 8:45 am]
BILLING CODE 4910-9X-P


                                  SYNOPSIS OF
                      PROPOSED REPEAL OF THE RULES OF THE
                        DEPARTMENT OF NATURAL RESOURCES
                       ENVIRONMENTAL PROTECTION DIVISION
                        RELATING TO CLEAN FUELED FLEETS
                               CHAPTER 391-3-22

DNR proposes repeal of Chapter 391-3-22 Rules for Clean Fueled Fleets in its entirety.

                            STATEMENT OF RATIONALE
                         Rules for Clean Fueled Fleets

In 1994, the Rules for Clean Fueled Fleets (CFF), Chapter 391-3-22, were adopted.  The Rules were required by the Clean Air Act (CAA) for areas that were classified as serious or above with the 1990 1-hour ozone National Ambient Air Quality Standards (NAAQS).  The Atlanta area was classified as serious for 13 counties in the Atlanta Metropolitan area under this standard.  The area has since attained that standard, but was required to retain the program as an anti-backsliding measure for the 1997 8-hour ozone National Ambient Air Quality Standards.  By meeting the 1997 standard and being re-designated as attainment for the 1997 standard, the measure is no longer required for the current 2008 8-hour ozone National Ambient Air Quality Standard nonattainment area.  In addition, EPA has provided guidance to States that all 2005 and later vehicles have emission standards that are more stringent than the Clean Fueled Fleet requirements of the CAA.  Therefore, these rules are no longer necessary to fulfill the Clean Air Act requirements in the State Implementation Plan.  Since these rules are no longer required, and as part of the burden reduction measures under the Governor's February 13, 2012 Executive Order on regulatory reform, EPD proposes to repeal Chapter 391-3-22 in its entirety.


[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Rules and Regulations]
[Pages 41278-41279]
[FR Doc No: 2012-16949]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2012-0208; FRL-9697-9]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Reasonably Available Control Technology for the 1997 8-Hour
Ozone National Ambient Air Quality Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving the State Implementation Plan (SIP) revision
submitted by the State of Maryland. This revision pertains to the
requirements for meeting reasonably available control technology (RACT)
for oxides of nitrogen (NOX) and volatile organic compounds
(VOCs) for the 1997 8-hour ozone national ambient air quality standard
(NAAQS). These requirements are based on: A certification that
previously adopted RACT controls in Maryland's SIP, which were approved
by EPA under the 1-hour ozone NAAQS, are based on the currently
available technically and economically feasible controls and continue
to represent RACT for the 1997 8-hour ozone NAAQS implementation
purposes; a negative declaration demonstrating that no facilities exist
in Maryland for the applicable control technique guideline (CTG)
categories; and adoption of new or more stringent RACT determinations.
This action is being taken in accordance with the requirements of the
Clean Air Act (CAA).

DATES: This final rule is effective on August 13, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2012-0208. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (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 through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the state
submittal are available at the Maryland Department of the Environment,
1800 Washington Boulevard, Suite 705, Baltimore, Maryland 21230.

FOR FURTHER INFORMATION CONTACT: Jacqueline Lewis,<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Throughout this document, whenever ``we,'' ``us,'' or ``our'' is
used, we mean EPA. On May 14, 2012 (77 FR 28338), EPA published a
notice of proposed rulemaking (NPR) for the State of Maryland. The
formal SIP revision (MDE SIP Number 11-08) was submitted by the
Maryland Department of the Environment on October 17, 2011. EPA
proposed to approve the Maryland SIP revision for the requirements of
RACT for NOX and VOCs set forth in the CAA with respect to
the 1997 8-hour ozone standard.

II. Summary of SIP Revision

    Maryland's SIP revision contains the requirements of RACT set forth
in the CAA under the 1997 8-hour ozone NAAQS. Maryland's SIP revision
satisfies the 1997 8-hour ozone standard RACT requirements through (1)
certification that previously adopted RACT controls in Maryland's SIP
that were approved by EPA under the 1-hour ozone NAAQS are based on the
currently available technically and economically feasible controls and
continue to represent RACT for the 8-hour implementation purpose; (2) a
negative declaration demonstrating that no facilities exist in Maryland
for the applicable CTG categories; and (3) adoption of new or more
stringent RACT determinations. Other specific requirements of the CAA
and EPA's review and rationale for our proposed action are explained in
the NPR and will not be restated here. No public comments were received
on the NPR.

III. Final Action

    EPA is approving a revision to the Maryland SIP submitted by the
State of Maryland, through the Maryland Department of the Environment,
on October 17, 2011 that addresses the 1997 8-hour ozone NAAQS. EPA has
determined that Maryland has met the requirements of RACT for
NOX and VOCs set forth in the CAA with respect to the 1997
8-hour ozone standard.

IV. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 CAA. Accordingly, this action merely proposes to approve 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 CAA; 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.

B. Submission to Congress and the Comptroller General

    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).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 11, 2012. 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.
    This action, pertaining to Maryland's RACT provisions for
NOX and VOCs with respect to the 1997 8-hour ozone 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, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

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

    Dated: June 27, 2012.
W.C. Early,
Acting Regional Administrator, Region III.

    Therefore, 40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for 40 CFR part 52 continues to read as
follows:

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

0
2. In Sec.  52.1070, the table in paragraph (e) is amended by adding
the entry for ``RACT under the 1997 8-hour ozone NAAQS'' at the end of
the table to read as follows:

Sec.  52.1070  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
   Name of non-regulatory SIP          Applicable      State submittal                            Additional
            revision                geographic area          date        EPA approval date       explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
RACT under the 1997 8-hour ozone  Statewide..........        10/17/11   7/13/12 [Insert      ...................
 NAAQS.                                                                  page number where
                                                                         the document
                                                                         begins].
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2012-16949 Filed 7-12-12; 8:45 am]
BILLING CODE 6560-50-P


44081 Federal Register / Vol. 68, No. 143 / Friday, July 25, 2003 / Notices National Monument Development Concept Plan, Long Term Rehabilitation and Reuse for Historic Buildings, Implementation, New York Harbor, NY and NJ, Comment Period Ends: September 12, 2003, Contact: Cynthia Garrett ( 212) 363   3206 ext. 100. Revision of FR Notice Published on 7/ 11/ 2003: Correction to Contact Person Name and Telephone Number. EIS No. 030327, Draft EIS, FRC, CT, Housatonic River Hydroelectric Project, Application to Relicense Existing Licenses for Housatonic Project No. 2576   022 and the Falls Village Project No. 2597   019, Housatonic River Basin, Fairfield, New Haven and Litchfield Counties, CT, Comment Period Ends: September 16, 2003, Contact: Jack Duckworth ( 202) 502   6392. Revision of FR Notice Published on 7/ 18/ 2003: CEQ Comment Period Ending 9/ 2/ 2003 has been Corrected to 9/ 16/ 2003.

Dated: July 22, 2003. Joseph C. Montgomery, Director, NEPA Compliance Division, Office of Federal Activities. [ FR Doc. 03   19009 Filed 7   24   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0231; FRL   7315   6]

Notice of Receipt of Requests to Voluntarily Cancel Fenridazone Potassium Pesticide Registration AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In accordance with section 6( f)( 1) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended, EPA is issuing a notice of receipt of request by a registrant to voluntarily cancel a certain pesticide registration. DATES: Unless the Agency receives any substantive comments within the comment period that would merit its further review of this request, or the request has been withdrawn by August 25, 2003, EPA intends to issue an order canceling the registration at the close of the comment period. FOR FURTHER INFORMATION CONTACT: Demson Fuller, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8062; e mail address: fuller. demson@ epamail. epa.. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0231. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. What Action is the Agency Taking?

This notice announces receipt by the Agency of a request from the registrant to cancel its EPA Registration for the pesticide product containing the active ingredient, fennridazone potassium. The technical registrant, Monsanto Company submitted a letter to the Agency on May 20, 2003, requesting a voluntary cancellation of their only registration for the product containing fenridazone potassium. This registration is listed in the following Table 1.

TABLE 1.   REGISTRATIONS WITH PENDING REQUESTS FOR CANCELLATION Registration No. Product Name Chemical Name 524   453 Hybrex 2LC Chemical Hybridizing Agent Fenridazone potassium Under section 6( f)( 1)( A) of FIFRA, registrants may request, at any time, that their pesticide registrations be canceled or amended to terminate one or more pesticide uses. Section 6( f)( 1)( B) of FIFRA requires that before acting on a request for voluntary cancellation, EPA must provide a 30   day public comment period on the request for voluntary cancellation. In addition, section 6( f)( 1)( C) of FIFRA requires that EPA provide a 180   day comment period on a request for voluntary termination of any minor agricultural use before granting the request, unless: ( 1) The registrants request a waiver of the comment period, or ( 2) the Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment. The registrant has requested that EPA waive the 180   day comment period. EPA is granting the registrants' request to waive the 180   day comment period. Therefore, EPA will provide a 30   day comment period on the proposed requests. EPA anticipates granting the cancellation request shortly after the end of the 30   day comment period for this notice VerDate Jan< 31> 2003 15: 23 Jul 24, 2003 Jkt 200001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 25JYN1. SGM 25JYN1 44082 Federal Register / Vol. 68, No. 143 / Friday, July 25, 2003 / Notices unless the Agency receives substantive comments within the comment period that would merit further review of the request. The registration for which cancellation was requested is identified in Table 1. of this unit. Unless a request is withdrawn by the registrant within 30 days of publication of this notice, orders will be issued canceling this registration. Users of this pesticide or anyone else desiring the retention of a registration should contact the applicable registrant directly during this 30   day period. Table 2 of this unit includes the name and address of record for the registrant of the product in Table 1 of this unit.

TABLE 2.   REGISTRANTS REQUESTING VOLUNTARY CANCELLATION EPA Company No. Company Name and Address 524 Monsanto Company 600 13th Street, NW Suite 600 Washington, DC 20005 III. What is the Agency's Authority for Taking this Action?

Section 6( f)( 1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. Thereafter, the Administrator may approve such a request.

IV. Procedures for Withdrawal of Request Registrants who choose to withdraw a request for cancellation must submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT, postmarked before August 25, 2003. This written withdrawal of the request for cancellation will apply only to the applicable FIFRA section 6( f)( 1) request listed in this notice. If the product( s) have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling. The withdrawal request must also include a commitment to pay any reregistration fees due, and to fulfill any applicable unsatisfied data requirements. V. Provisions for Disposition of Existing Stocks The effective date of cancellation will be the date of the cancellation order. The order effecting this requested cancellation will generally permit a registrant to sell or distribute existing stocks for 1 year after the date the cancellation request was received. This policy is in accordance with the Agency's statement of policy as prescribed in the Federal Register of June 26, 1991 ( 56 FR 29362) ( FRL   3846   4). Exceptions to this general rule will be made if a product poses a risk concern, or is in noncompliance with reregistration requirements, or is subject to a Data Call In. In all cases, productspecific disposition dates will be given in the cancellation orders. Existing stocks are those stocks of registered pesticide products which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the cancellation action. Unless the provisions of an earlier order apply, existing stocks already in the hands of dealers or users can be distributed, sold, or used legally until they are exhausted, provided that such further sale and use comply with the EPA approved label and labeling of the affected product. Exception to these general rules will be made in specific cases when more stringent restrictions on sale, distribution, or use of the products or their ingredients have already been imposed, as in a Special Review action, or where the Agency has identified significant potential risk concerns associated with a particular chemical. In the letter the Agency received from the registrant on May 20, 2003, the registrant stated that the Hybrex 2LC Chemical Hybridizing product has not been sold since 1989 nor has the chemical ever been distributed. Therefore, no products should be in the channels of trade.

List of Subjects Environmental protection, Pesticides and pests.

Dated: July 18, 2003.

Richard P. Keigwin, Jr.,

Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs.

[ FR Doc. 03   19007 Filed 7   24   03; 8: 45 am]

BILLING CODE 6560   50   S FEDERAL COMMUNICATIONS COMMISSION [ CC Docket 98   67; DA 03   2332]

Notice of Certification of State Telecommunications Relay Service ( TRS) Programs AGENCY: Federal Communications Commission. ACTION: Notice.

SUMMARY: The purpose of this document is to notify state Telecommunications Relay Service ( TRS) programs that certification of their program has been granted through July 26, 2008. Notice is hereby given that the applications for certification of state Telecommunications Relay Services ( TRS) programs of the states listed below have been granted, subject to the condition described below, pursuant to Title IV of the Americans with Disabilities Act ( ADA), 47 U. S. C. 225( f)( 2), and section 64.605( b) of the Commission's rules, 47 CFR 64.605( b). The Commission will provide further Public Notice of the certification of the remaining applications for certification once final review of those states' applications has been completed. On the basis of the state applications, the Commission has determined that: the TRS program of the states meet or exceed all operational, technical, and functional minimum standards contained in section 64.604 of the Commission's rules, 47 CFR 64.604; the TRS programs of the listed states make available adequate procedures and remedies for enforcing the requirements of the state program; and the TRS programs of the listed states in no way conflict with federal law. DATES: This certification shall remain in effect for a five year period, beginning July 26, 2003, and ending July 25, 2008, pursuant to 47 CFR 64.605( c). ADDRESSES: Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Erica Myers, ( 202) 418   2429 ( voice), ( 202) 418   0464 ( TTY), or e mail Erica. Myers@ fcc. gov.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Public Notice, DA 03   2332, CC Docket No. CC 98   67, released July 16, 2003. Copies of applications for certification are available for public inspection and copying during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY   A257, Washington, DC 20554. The applications for certification are also available on the Commission's web VerDate Jan< 31> 2003 15: 23 Jul 24, 2003 Jkt 200001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 25JYN1. SGM 25JYN1


[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Rules and Regulations]
[Pages 35115-35117]
[FR Doc No: 2013-13857]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2012-C-0224]

Listing of Color Additives Exempt From Certification; Mica-Based
Pearlescent Pigments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the safe use of mica-based
pearlescent pigments prepared from titanium dioxide and mica as color
additives in distilled spirits containing not less than 18 percent and
not more than 23 percent alcohol by volume but not including distilled
spirits mixtures containing more than 5 percent wine on a proof gallon
basis. This action is in response to a petition filed by E. & J. Gallo
Winery.

DATES: This rule is effective July 15, 2013. See section VIII for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing by July 12,
2013.

ADDRESSES: You may submit either electronic or written objections and
requests for a hearing identified by Docket No. FDA-2012-C-0224, by any
of the following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-C-0224 for this rulemaking. All objections
received will be posted without change to http://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Raphael A. Davy, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In a document published in the Federal Register of March 22, 2012
(77 FR 16784), FDA announced that a color additive petition (CAP
2C0294) had been filed by E. & J. Gallo Winery, c/o Keller and Heckman
LLP, One Embarcadero Center, Suite 2110, San Francisco, CA 94111. The
petition proposed to amend the color additive regulations in Sec.
73.350 (21 CFR 73.350) Mica-based pearlescent pigments, to provide for
the safe use of mica-based pearlescent pigments prepared from titanium
dioxide and mica in distilled spirits containing not less than 18
percent and not more than 23 percent alcohol by volume but not
including distilled spirits mixtures containing more than 5 percent
wine on a proof gallon basis. The maximum use level of the pigments
proposed by the petitioner is 0.07 percent by weight in the distilled
spirits. Mica-based pearlescent pigments prepared from titanium dioxide
and mica are currently permitted under Sec.  73.350 for use as color
additives in amounts up to 1.25 percent by weight in cereals,
confections and frostings, gelatin deserts, hard and soft candies
(including lozenges), nutritional supplement tablets and gelatin
capsules, and chewing gum. Mica-based pearlescent pigments prepared
from titanium dioxide, iron oxide, and mica are permitted for use as
color additives in ingested drugs under Sec.  73.1350 (21 CFR 73.1350)
and in contact lenses under 21 CFR 73.3128.

II. Safety Evaluation

A. Determination of Safety

    Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be
listed for a particular use unless a fair evaluation of the data and
information available to FDA establishes that the color additive is
safe for that use. FDA's color additive regulations in 21 CFR 70.3(i)
define ``safe'' as the existence of ``convincing evidence that
establishes with reasonable certainty that no harm will result from the
intended use of the color additive.''
    To establish with reasonable certainty that a color additive
intended for use in food is safe under its intended conditions of use,
we consider the projected human dietary intake of the additive,
toxicological data on the additive, and other relevant information
available to us. We compare an individual's estimated daily intake
(EDI) of the additive from all sources for both the mean and high-
intake consumer to an acceptable daily intake (ADI) level established
by toxicological data. The EDI is determined by projections based on
the amount of the additive proposed for use in particular foods and on
data regarding the amount consumed from all sources of the additive.

B. Safety of the Petitioned Use of the Color Additive

    During our review of the safety of the petitioned use of mica-based
pearlescent pigments in distilled spirits, we considered the exposure
to the color additive from both its petitioned use and from the uses
for which it is currently permitted in food and ingested drugs under
Sec. Sec.  73.350 and 73.1350, respectively. In estimating the
cumulative exposure to these pigments, we also considered the exposure
to these pigments from their uses in contact lenses and determined that
such exposure would be negligible.
    For those consuming mica-based pearlescent pigments from the
petitioned use in distilled spirits, we have estimated the exposure to
mica-based pearlescent pigments at the mean and at the 90th percentile
to be 0.12 grams/person/day (g/p/d) and 0.25 g/p/d, respectively, for
persons aged 2 years or more (Ref. 1).
    Previously, in the issuance of Sec.  73.350 we calculated a
cumulative EDI (CEDI) for the use of mica-based pearlescent pigments in
food (Sec.  73.350) and ingested drugs (Sec.  73.1350) (71 FR 31927,
June 2, 2006). For those exposed to mica-based pearlescent pigments
from their use in food and ingested drugs, the CEDI was estimated to be
0.24 g/p/d and 0.48 g/p/d at the mean and at the 90th percentile,
respectively, for persons aged 2 years or more, and to be 0.26 g/p/d
and 0.52 g/p/d at the mean and at the 90th percentile, respectively,
for the subgroup of children aged 2 to 5 years (71 FR 31927). This
exposure estimate used food consumption data from the 1994 to 1996 and
1998 Continuing Survey of Food Intakes by Individuals

(CSFII) survey, which was integrated into the National Health and
Nutrition Examination Survey (NHANES) in 2002.
    In our current safety assessment, we updated the previous exposure
to mica-based pearlescent pigments from all regulated uses in foods
using the latest publicly available NHANES food consumption data (2003
to 2008). In estimating the exposure from the use of mica-based
pearlescent pigments in ingested drugs, we relied on the estimates used
in the issuance of Sec.  73.350 (71 FR 31927). The current CEDI of
mica-based pearlescent pigments from the petitioned use in distilled
spirits and its regulated uses in food and ingested drugs is 0.26 g/p/d
at the mean and 0.52 g/p/d at the 90th percentile for persons aged 2
years or more, and also for the subgroup of children aged 2 to 5 years
(Ref. 1). The current CEDIs of mica-based pearlescent pigments are not
significantly different from the previous CEDIs, as the percent of the
population consuming distilled spirits from the petitioned use is low
compared to the percent of the population consuming foods and ingested
drugs formulated with mica-based pearlescent pigments. Further, our
estimate assumes no contribution from the petitioned use of mica-based
pearlescent pigments to the CEDI for the subgroup of children aged 2 to
5 years because they do not typically consume distilled spirits (Ref.
1).
    In our previous safety evaluation of mica-based pearlescent
pigments in food, which the petitioner referenced, we established an
ADI level for mica-based pearlescent pigments to be 1.8 g/p/d based on
a 2-year rat carcinogenicity bioassay that tested a 1:1 blend of mica
and titanium dioxide (71 FR 31927 at 31928). Since the CEDI is less
than the ADI, we conclude that the proposed expanded use of mica-based
pearlescent pigments as color additives at a level of up to 0.07
percent by weight in distilled spirits is safe (Ref. 2).

III. Conclusion

    Based on the data and information in the petition and other
relevant material, FDA concludes that the petitioned use of mica-based
pearlescent pigments prepared from titanium dioxide and mica as a color
additive at a level of up to 0.07 percent by weight in distilled
spirits containing not less than 18 percent and not more than 23
percent alcohol by volume but not including distilled spirits mixtures
containing more than 5 percent wine on a proof gallon basis is safe. We
further conclude that the additive will achieve its intended technical
effect and is suitable for use in coloring food. Therefore, we conclude
that the color additive regulations should be amended as set forth in
this document. In addition, based upon the factors listed in 21 CFR
71.20(b), we conclude that certification of titanium dioxide-coated
mica-based pearlescent pigments is not necessary for the protection of
the public health.

IV. Public Availability of Documents

    In accordance with Sec.  71.15 (21 CFR 71.15), the petition and the
documents that we considered and relied upon in reaching our decision
to approve the petition will be made available for public disclosure
(see FOR FURTHER INFORMATION CONTACT). As provided in Sec.  71.15, we
will delete from the documents any materials that are not available for
public disclosure.

V. Environmental Impact

    We have previously considered the environmental effects of this
rule as announced in the notice of filing for CAP 2C0294 (77 FR 16784,
March 22, 2012). No new information or comments have been received that
would affect our previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

VII. Section 301(ll) of the FD&C Act

    FDA's review of this petition was limited to section 721 of the
FD&C Act. This final rule is not a statement regarding compliance with
other sections of the FD&C Act. For example, the Food and Drug
Administration Amendments Act of 2007, which was signed into law on
September 27, 2007, amended the FD&C Act to, among other things, add
section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)). Section 301(ll) of
the FD&C Act prohibits the introduction or delivery for introduction
into interstate commerce of any food that contains a drug approved
under section 505 of the FD&C Act (21 U.S.C. 355), a biological product
licensed under section 351 of the Public Health Service Act (42 U.S.C.
262), or a drug or biological product for which substantial clinical
investigations have been instituted and their existence has been made
public, unless one of the exemptions in section 301(ll)(1)-(4) of the
FD&C Act applies. In our review of this petition, we did not consider
whether section 301(ll) of the FD&C Act or any of its exemptions apply
to food containing this color additive. Accordingly, this final rule
should not be construed to be a statement that a food containing this
color additive, if introduced or delivered for introduction into
interstate commerce, would not violate section 301(ll) of the FD&C Act.
Furthermore, this language is included in all color additive final
rules that pertain to food and therefore should not be construed to be
a statement of the likelihood that section 301(ll) of the FD&C Act
applies.

VIII. Objections

    This rule is effective as shown in the DATES section of this
document; except as to any provisions that may be stayed by the filing
of proper objections. Any person who will be adversely affected by this
regulation may file with the Division of Dockets Management (see
ADDRESSES) either electronic or written objections regarding this
document. Each objection shall be separately numbered, and each
numbered objection shall specify with particularity the provisions of
the regulation to which objection is made and the grounds for the
objection. Each numbered objection on which a hearing is requested
shall specifically so state. Failure to request a hearing for any
particular objection shall constitute a waiver of the right to a
hearing on that objection. Each numbered objection for which a hearing
is requested shall include a detailed description and analysis of the
specific factual information intended to be presented in support of the
objection in the event that a hearing is held. Failure to include such
a description and analysis for any particular objection shall
constitute a waiver of the right to a hearing on the objection. It is
only necessary to send one set of documents. Identify documents with
the docket number found in brackets in the heading of this document.
Any objections received in response to the regulation may be seen in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov. FDA will publish notice of the objections that the
Agency has received or lack thereof in the Federal Register.

IX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

    1. Memorandum from Hyoung S. Lee, Division of Petition Review,
Chemistry Review Team, to Raphael Davy, Division of Petition Review,
Regulatory Group I, May 30, 2012.
    2. Memorandum from Tina W. Walker, Division of Petition Review,
Toxicology Team, to Raphael Davy, Division of Petition Review,
Regulatory Group I, October 3, 2012.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for 21 CFR part 73 continues to read as
follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.

0
2. Section 73.350 is amended by revising paragraph (c)(1) to read as
follows:

Sec.  73.350  Mica-based pearlescent pigments.

* * * * *
    (c) * * *
    (1) The substance listed in paragraph (a) of this section may be
safely used as a color additive in food as follows:
    (i) In amounts up to 1.25 percent, by weight, in the following
foods: Cereals, confections and frostings, gelatin desserts, hard and
soft candies (including lozenges), nutritional supplement tablets and
gelatin capsules, and chewing gum.
    (ii) In amounts up to 0.07 percent, by weight, in distilled spirits
containing not less than 18 percent and not more than 23 percent
alcohol by volume but not including distilled spirits mixtures
containing more than 5 percent wine on a proof gallon basis.
* * * * *

    Dated: June 6, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2013-13857 Filed 6-11-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Notices]
[Page 30651]
[FR Doc No: E9-15253]

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SECURITIES AND EXCHANGE COMMISSION

 In the Matter of Paivis Corp., Peabodys Coffee, Inc., Penge
Corp., Petrol Industries, Inc. (n/k/a Caddo International, Inc.),
Phantom Entertainment, Inc., Phoenix Medical Technology, Inc., Phoenix
Metals USA II, Inc. (a/k/a TM Media Group, Inc.), Phymed, Inc., Pico
Products, Inc., and Piemonte Foods, Inc.; File No. 500-1; Order of
Suspension of Trading

June 24, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Paivis Corp. because it has not filed any periodic reports since the
period ended June 30, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Peabodys Coffee, Inc. because it has not filed any periodic reports
since the period ended December 31, 2004.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Penge Corp. because it has not filed any periodic reports since the
period ended March 31, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Petrol Industries, Inc. (n/k/a Caddo International, Inc.) because it
has not filed any periodic reports since the period ended September 30,
2005.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Phantom Entertainment, Inc. because it has not filed any periodic
reports since the period ended March 31, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Phoenix Medical Technology, Inc. because it has not filed any periodic
reports since the period ended July 2, 2000.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Phoenix Metals USA II, Inc. (a/k/a TM Media Group, Inc.) because it has
not filed any periodic reports since the period ended December 31,
2001.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Phymed, Inc. because it has not filed any periodic reports since the
period ended December 31, 1999.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Pico Products, Inc. because it has not filed any periodic reports since
the period ended April 30, 1999.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Piemonte Foods, Inc. because it has not filed any periodic reports
since the period ended February 27, 1999.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed companies is suspended for the period from 9:30 a.m. EDT
on June 24, 2009, through 11:59 p.m. EDT on July 8, 2009.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. E9-15253 Filed 6-24-09; 11:45 am]
BILLING CODE 8010-01-P