Posted: 	Friday, February 21, 2003

	3:45 p.m.

	                 UNITED STATES OF AMERICA

        DEPARTMENT OF TRANSPORTATION

               OFFICE OF THE SECRETARY

                        WASHINGTON, D.C.

							Served:  February 21, 2003

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In the Matter of

Application for Approval of Agreement by the

International Air Transport Association

Docket OST-2003-14480

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NOTICE SHORTENING ANSWER PERIOD

On February 7, 2003, the International Air Transport Association (IATA)
filed an agreement in the above-captioned docket for approval.  Comments
would normally be due 21 days from filing, i.e., on February 26, 2003.

On February 13, 2003, the High Tech Airfreight Shippers Coalition (the
Coalition) submitted a letter seeking extension for a minimum of 90 days
beyond the normal 21-day comment period.  Answers to the Coalition’s
request would be due on February 26, 2003.  In order to have the benefit
of comments on the Coalition’s request prior to the 21-day comment
date on IATA’s application, we are shortening the answer date on the
Coalition’s request to 3 p.m. February 24, 2003.

Therefore, acting under authority assigned to the Director, Office of
International Aviation, 14 CFR 385, we require that answers to the
request by the Coalition be filed by 3 p.m. February 24, 2003

We will serve this notice by facsimile on all interested parties who
have filed pleadings in the docket, as well as on those who were served
by IATA with its application.  We authorize responsive comments to be
served by facsimile or email.

By:

PAUL L. GRETCH

Director

Office of International Aviation

(SEAL)

Dated:  February 21, 2003

An electronic version of this notice is available on the World Wide Web
at

http://dms.dot.gov//reports/reports_aviation.asp


[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Notices]
[Page 26050]
[FR Doc No: 2018-11990]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP18-839-000.
    Applicants: White River Hub, LLC.
    Description: Annual Report of Fuel Gas Reimbursement Percentage for
2018 of White River Hub, LLC.
    Filed Date: 5/23/18.
    Accession Number: 20180523-5230.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: RP18-840-000.
    Applicants: Questar Southern Trails Pipeline Company.
    Description: Annual Report of Fuel Gas Reimbursement Percentage for
2018 of Questar Southern Trails Pipeline Company.
    Filed Date: 5/23/18.
    Accession Number: 20180523-5231.
    Comments Due: 5 p.m. ET 6/4/18.

    Docket Numbers: RP18-841-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: Sec.  4(d) Rate Filing: Non-conforming Agreement
Cleanup Filing to be effective 6/29/2018.
    Filed Date: 5/29/18.
    Accession Number: 20180529-5028.
    Comments Due: 5 p.m. ET 6/11/18.

    Docket Numbers: RP18-842-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Update Filing
(APS June 18) to be effective 6/1/2018.
    Filed Date: 5/29/18.
    Accession Number: 20180529-5065.
    Comments Due: 5 p.m. ET 6/11/18.

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

    Dated: May 30, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-11990 Filed 6-4-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13166-13168]
[FR Doc No: 2018-06107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82928; File No. SR-Phlx-2018-23]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Rule 990
Regarding the Requirements for Securities Listed on the Exchange Issued
by Nasdaq, Inc. or Its Affiliates

March 22, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 9, 2018, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I and II, below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 990 regarding the requirements
for securities listed on the exchange issued by Nasdaq, Inc.
(``Nasdaq'') or its affiliates.
    The text of the proposed rule change is set forth below. Proposed
new language is italicized; deleted text is in brackets.
* * * * *

Rule 990. Additional Requirements for Securities Listed on the Exchange
Issued by Nasdaq or Its Affiliates

    (a) For purposes of this Rule 990, the terms below are defined as
follows:
    (1) No change.
    (2) ``Affiliate Security'' means any security issued by a Nasdaq
Affiliate or any Exchange-listed option on any such security, with the
exception of Trust Shares as defined in Rule 803(i) and Index Fund
Shares as defined in Rule 803(l).
    (b) Upon initial and throughout continued listing and trading of
the Affiliate Security on the Exchange, the Exchange shall:
    (1) [file a report quarterly with the Securities and Exchange
Commission (``Commission'')]provide a quarterly report to the
Exchange's Regulatory Oversight Committee detailing the Exchange's
monitoring of:

    (A)-(B) No change.
    (2) engage an independent accounting firm once a year to review and
prepare a report on the Affiliate Security to ensure that the Nasdaq
Affiliate is in compliance with the listing requirements contained in
the Rule 800 Series and promptly [forward to the Commission]provide
PHLX's Regulatory Oversight Committee with a copy of the report
prepared by the independent accounting firm.
    (c) No change.
* * * * *
    (b) Not applicable.
    (c) Not applicable.

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

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

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

1. Purpose
    The Exchange proposes to amend Rule 990 (Additional Requirements
for Securities Listed on the Exchange Issued by Nasdaq or its
Affiliates) regarding the requirements for the listing of securities
that are listed on the exchange issued by Nasdaq or its affiliates.
    Rule 990 sets forth certain monitoring requirements that must be
met throughout the continued listing of securities issued by Nasdaq or
its affiliates. More specifically, Rule 990 provides that, upon initial
and throughout continued listing of the Affiliate Security \3\ on the
Exchange, the Exchange shall:
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    \3\ Pursuant to Rule 990(a)(2), ``Affiliate Security'' means any
security issued by a Nasdaq Affiliate, with the exception of Trust
Shares as defined in Rule 803(i) and Index Fund Shares as defined in
Rule 803(l), and pursuant to Rule 990(a)(1), ``Nasdaq Affiliate''
means Nasdaq, Inc. and any entity that directly or indirectly,
through one or more intermediaries, controls, is controlled by, or
is under common control with Nasdaq, Inc., where ``control'' means
that the one entity possesses, directly or indirectly, voting
control of the other entity either through ownership of capital
stock or other equity securities or through majority representation
on the board of directors or other management body of such entity.
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     File a report quarterly (``Quarterly Report'') with the
Commission detailing the Exchange's monitoring of (a) the Nasdaq
Affiliate's compliance with the listing requirements; and (b) the
trading of the Affiliate Security; and
     engage an independent accounting firm once a year to
review and prepare a report on the Affiliate Security to ensure that
the Nasdaq Affiliate is in compliance with the listing requirements
(``Annual Report'') and promptly forward to the Commission a copy of
the report prepared by the independent accounting firm.
    In discussions with the Commission Staff regarding the Exchange's
Rule 990, it was determined that the Exchange no longer needs to
provide to the Commission copies of the reports specified in paragraphs
(b)(1) and (b)(2) thereunder; instead, the Exchange must provide these
reports to the Exchange's Regulatory Oversight Committee. Accordingly,
the Exchange proposes to amend Rule 990 to remove the requirement that
the Quarterly Report be filed with the Commission and that copies of
the Annual Report be forwarded to the Commission, and to require
instead that copies of each such report be provided to PHLX's
Regulatory Oversight Committee. In addition, the Exchange proposes to
modify the definition of ``Affiliate Security'' in Rule 990(a)(2) to
include any Exchange-listed option on any such security. Finally, the
Exchange proposes to modify Rule 990(b) to require that the Exchange
also follow Rule 990 upon initial and throughout continued trading, not
just listing, of the ``Affiliate Security'' on the Exchange.
    No other changes would be made to Rule 990, which would continue to
require that PHLX file a report with the Commission if it determines
that the Nasdaq Affiliate is not in compliance with the listing
requirements.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\4\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\5\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to, and perfect the mechanism of a
free and open market and a national market system and, in general, to
protect investors and the public interest.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, remove impediments to, and
perfect the mechanism of a free and open market and a national market
system and, in general, to protect investors and the public interest,
because the proposed changes would reduce the paperwork received by the
Commission and ease the burden of submitting the Quarterly and Annual
Reports, while continuing to help protect against concerns that the
Exchange will not effectively enforce its rules with respect to the
listing and trading of Affiliate Securities. The proposed rule change
would not change the information available to the Commission. The
Exchange understands that these reports are subject to Section 17A of
the Exchange Act \6\ and that it will be required to keep and preserve,
and to furnish to the Commission upon request, copies of these reports
in accordance with Rule 17a-1 thereunder.\7\
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    \6\ 15 U.S.C. 78q.
    \7\ 17 CFR 240.17a-1.
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    The Exchange believes that the proposed change adding Exchange-
listed options to the definition of ``Affiliate Security'' in Rule
990(a)(2) and requiring that the Exchange also follow Rule 990 upon
initial and throughout continued trading, not just listing, of the
``Affiliate Security'' on the Exchange, will expand the scope of Rule
990, which would help eliminate any perception of a potential conflict
of interest if a Nasdaq Affiliate seeks to list and/or trade an option
on an Affiliate Security on the Exchange and thus promote just and
equitable principles of trade, remove impediments to a free and open
market and protect investors and the public interest by helping protect
against concerns that the Exchange will not effectively enforce its
rules with respect to the listing and trading of these securities.

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

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

proposed rule change is not intended to address competitive issues but
rather to reduce the paperwork received by the Commission, ease the
burden of submitting the Quarterly and Annual Reports, and provide
greater clarity in the Exchange's rules, without changing the
information available to the Commission.

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

    No written comments were either solicited or received.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \8\ and Rule 19b-4(f)(6) thereunder.\9\
Because the foregoing proposed rule change does not: (i) Significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative for
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, it has become effective pursuant to
Section 19(b)(3)(A)(iii) of the Act \10\ and subparagraph (f)(6) of
Rule 19b-4 thereunder.\11\
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    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \12\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \12\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-Phlx-2018-23 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2018-23. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2018-23 and should be submitted on
or before April 17, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-06107 Filed 3-26-18; 8:45 am]
 BILLING CODE 8011-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I started smoking at a young age (17), and have been ruled by cigarettes for 22 years. Six months ago I started using e-cigarettes and immediately laid my cigarettes aside. I no longer experience coughing fits in the middle of the night, spit up mucus in the mornings, and I can breathe when I exercise. I don’t smell like an ashtray, and my kids love that I can spend more time with them indoors instead of outside smoking. Not only are the benefits to my health a plus to using e-cigarettes, but I am saving money as well. Please consider all the ramifications of these regulations and how it will affect all of the people that used e-cigarettes to quit smoking and lead happier healthier lives.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

Thank you for your time


[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)]
[Notices]
[Pages 1365-1366]
[FR Doc No: 2018-00358]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-3310 and FDA-2016-E-3341]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ENTYCE

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 ENTYCE and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that animal drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by March
12, 2018. 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 July 10, 2018. 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 March 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of March 12, 2018. 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 Nos.
FDA-2016-E-3310 and FDA-2016-E-3341 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; ENTYCE.'' 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.
     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.gpo.gov/fdsys/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.

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 animal drug products, the
testing phase begins on the earlier date when either a major
environmental effects test was initiated for the drug or when an
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the animal drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, 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 an animal
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(4)(B).
    FDA has approved for marketing the animal drug product ENTYCE
(capromorelin). ENTYCE is indicated for appetite stimulation in dogs.
Subsequent to this approval, the USPTO received patent term restoration
applications for ENTYCE (U.S. Patent Nos. 6,107,306 and 6,673,929) from
RaQualia Pharma Inc., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated December 1, 2016, FDA advised the USPTO that this animal
drug product had undergone a regulatory review period and that the
approval of ENTYCE 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
ENTYCE is 1,645 days. Of this time, 1,589 days occurred during the
testing phase of the regulatory review period, while 56 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the FD&C Act (21
U.S.C. 355(i)) became effective: November 16, 2011. The applicant
claims December 5, 2002, as the date the investigational new animal
drug application (INAD) became effective. However, FDA records indicate
that the INAD effective date was November 16, 2011, which was the date
a major health or environmental effects test is begun or the date on
which the Agency acknowledges the filing of a notice of claimed
investigational exemption for a new animal drug, whichever is earlier.
    2. The date the application was initially submitted with respect to
the animal drug product under section 512 of the FD&C Act (21 U.S.C.
360b): March 22, 2016. The applicant claims March 21, 2016, as the date
the new animal drug application (NADA) for ENTYCE (NADA 141-457) was
initially submitted. However, FDA records indicate that NADA 141-457
was submitted on March 22, 2016.
    3. The date the application was approved: May 16, 2016. FDA has
verified the applicant's claim that NADA 141-457 was approved on May
16, 2016.
    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 applications for patent extension,
this applicant seeks 1,826 and 1,827 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: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00358 Filed 1-10-18; 8:45 am]
BILLING CODE 4164-01-P


                     Cost and Small Business Analysis of
                 Proposed Revisions to Minimum Risk Exemption
                               November 9, 2012

Background
      Under FIFRA 25(b)(2), EPA may exempt from the requirements of FIFRA any pesticide that is "of a character unnecessary to be subject to [FIFRA]". Pursuant to this authority, in March 1996, EPA promulgated 40 CFR 152.25(g), which exempted from FIFRA any pesticide products consisting solely of specified ingredients that EPA judged to pose minimum risk to humans and the environment (61 FR 8876, March 6, 1996).  This provision was later redesignated as §152.25(f) (66 FR 64759, December 14, 2001).

      Unlike producers of registered pesticides, producers of products exempted under 152.25(f) do not register their products with EPA, pay registration fees, or report production to EPA.  Exempt products are required to provide certain information on their labels, including the names of both the active and inert ingredients.  However, the names found on labels are often the technical names, which are not known to consumers, may not be known to all inspectors, which can lead to confusion and delays in enforcement.

      EPA is modifying the label requirements in the exemption to require the use of specific common chemical names in lists of ingredients on minimum risk pesticide product labels, which will facilitate enforcement, and to require producer contact information on the label. EPA is also proposing to more clearly specify the active and inert ingredients permitted in products eligible for the exemption from regulation for minimum risk pesticides (40 CFR 152.25(f)).  EPA is reorganizing these lists and adding specific chemical identifiers to make it clearer to manufacturers; the public; and Federal, state, and tribal inspectors the specific ingredients that are permitted in minimum risk pesticide products.

      The purpose of this analysis is to estimate the cost of label changes as proposed, as separate and distinct from (i.e., incremental to) routine label changes that producers already undertake and assess the impacts on small entities.  The document is organized as follows.  In section 2, the profile of affected industry is described, including the total number of minimum risk pesticide products currently on the market and the firms that produce these products.  In section 3, the anticipated costs of the proposed rule are estimated for three implementation periods: immediate, two years, and three years.  The cost per label change and the total number of label changes anticipated from the proposed rule are estimated, from which the industry cost is derived.  Using the cost estimates of section 3, the impacts on small businesses are analyzed in section 4.  Based on this analysis, EPA concludes that there will not be a significant impact on substantial number of small entities.
Profile of Affected Industry
      In this section, the minimum risk pesticide industry that would be affected by the proposed rule, once final, is delineated.  Minimum risk pesticide products are identified in subsection 2.1 and the firms that produce these products are described in subsection 2.2.
Minimum Risk Pesticide Products
      Table 1 shows the number and types of minimum risk pesticide products.  The information in Table 1 is derived primarily from lists of products registered in 14 states (EPA, 2010).  Although minimum risk products are exempt from registration by EPA, approximately 37states require registration of these pesticide products.  Many of these states provide their pesticide registration lists (including for minimum risk pesticides) online, and available to the public.  In addition to the states' registration lists, the list of personal insect repellent products is also derived from the retail store scanner data (Nielsen, 2008) and on-line searches.

                        Table 1.  Minimum Risk Products
Type of Product
                                    Number
Antimicrobial
                                       2
Deodorizer
                                       1
Fungicide
                                       9
Fungicide & Herbicide
                                       2
Herbicide
                                      62
Herbicide & Fertilizer
                                      32
Rodenticide
                                       6
Insecticide
                                      149
Insecticide/Repellent
                                       2
Repellent, Animals
                                      141
Repellent, Insect for Animals
                                      31
Repellent, Insect for Pets
                                      20
Repellent, Insect
                                      218
Repellent, Insect, Skin-applied
                                      74
Unknown
                                       8
Total
                                      757
                             Sources: State minimum risk product registrations (2010)
             	   and AC Nielsen (2008).

      Only the products that comply with 40 CFR 152.25(f) would be subject to the rule.  Based on the Agency's enforcement experience and review of minimum risk insect repellent labels, some products marketed under the minimum risk exemption are not in full compliance.  They may, for example, include inert ingredients that have not been approved for these products.  When identified, these products must be registered with EPA or reformulated to comply with 40 CFR 152.25(f).

      Since EPA may have incomplete information regarding the number of products out of compliance, we assume that all 757 products in Table 1 are subject to the rule, which would result in an overestimation of the cost of the rule.  On the other hand, since exempt products are not registered, Table 1 may not include all of the minimum risk pesticide products on the market, leading to an underestimate of the cost of the rule.  The net effect of these two opposing factors cannot be determined due to the lack of data.

Firms Producing Minimum Risk Products
      Table 2 summarizes the number of firms producing the minimum risk pesticide products identified by EPA.  A total of 216 firms were identified. Some of these firms (23) produce both skin-applied insect repellents and other minimum risk pesticide products.

    Table 2. Number of Minimum Risk Pesticide Product Firms by Product Type
Firms Producing
                                Number of Firms
                                   Products
Skin-Applied Insect Repellents
                                      34
                                      74
Other Products
                                      205
                                      683
Both of the Above
                                      23

All Products
                                      216
                                      757
         	   Sources: State minimum risk product registrations (2010) and AC Nielsen (2008).

      For the purpose of cost analysis, the firm data is needed for the highest level of multi-layered corporate organizations, called the parent firm.  EPA used the Dun & Bradstreet (D&B) Market Spectrum database to obtain firm size and financial data, and to determine the parent firms (Dun & Bradstreet, 2009).  D&B is a comprehensive source of financial information on entities, including firm locations, sales, and primary business classifications under North American Industrial Classification System code (NAICS).  Based on a review of this data, 192 parent companies were identified (Table 3).  Not all parent companies could be determined from the D&B database.  Together, the 192 parent companies account for 541 minimum risk products, or about 79 percent of those identified by EPA.

      Table 3 shows the distribution of firms by NAICS code.  Most firms in the minimum risk pesticide industry belong to Chemical Manufacturing (NAICS code 325) and Merchant Wholesalers, Nondurable Goods (NAICS code 424).  Forty-two firms are divided among 31 NAICS codes, including NAICS codes 311, 332, and 333, each with four firms), NAICS codes 335 with 3 firms, NAICS codes 112, 115, 445, 453, 525, each with two firms, and 17 NAICS codes with one firm in each.

                Table 3.  Producers of Minimum Risk Pesticides
                              3-digit NAICS Code
                            NAICS Code Description
                            Number of parent firms
                                      325
Chemical Manufacturing
                                      72
                                      339
Miscellaneous Manufacturing
                                       8
                                      423
Merchant Wholesalers, Durable Goods
                                      11
                                      424
Merchant Wholesalers, Nondurable Goods
                                      32
                                      444
Building Material and Garden Equipment and Supplies Dealers
                                       7
                                      541
Professional, Scientific, and Technical Services
                                       7
                                      561
Administrative and Support Services
                                      13
                                    Others

                                      42

Total with classification
                                      192
Sources:  State product registrations (2010), AC Nielsen retail store scanner data (2008).

Cost of Label Changes
      In this section, the cost of the proposed rule, once final, is estimated.  The cost of the rule consists of a one-time change in the design of the label to comply with the proposed requirements.  The incremental cost of the proposed rule depends on the extent to which the change is separate and distinct from the routine label changes firms undertake on regular basis.  The section is organized as follows: The methodology for estimating the cost per label change is presented in subsection 3.1.  In subsection 3.2, the total industry cost is estimated by multiplying the cost per label change by the total number of label changes that result from the proposed rule.
Cost per Label Change Methodology
     In general, the cost of a label change depends on the size and type of packages for products, which determine types of graphics and printing methods.  Also, the firm size can influence the cost of labeling as smaller firms may choose setups that are less expensive (e.g., graphic designs with fewer colors).  It is noted that firms change their labels on a routine basis to update or "refresh" their product labels even if not required by government regulation and this is an important factor that determines the magnitude of the cost of the rule.  The proposed rule, once final, will impose some cost to redesign the label to accommodate new EPA requirements.  The expected cost of the label change will depend on the duration of the rule implementation period, which will determine the extent to which the EPA's requirements can be incorporated into firm's routine relabeling operations.

     To estimate the cost of the rule, EPA uses the Food and Drug Administration's (FDA) labeling cost model (FDA, 2003) developed for estimating the labeling cost for food products.  This is a reasonable model for minimum risk pesticide products because the package sizes and shapes of exempt pesticide products are similar to the packaging for many food products.  According to this model, firm's labeling cost consists of:
      1. Setup costs
            a. Administrative costs
            b. Graphic design
            c. Printing setup  -  prepress and engraving
      2. Printing cost

     Administrative costs include working with outside vendors to supply graphic design, prepress and engraving, market testing of redesigned graphics, and meeting EPA requirements (e.g., searching the common chemical names for the ingredients).  Firms often work with a graphic design company to redesign their label graphics.  Depending on the type of graphic designs (e.g., number of colors), costs vary.  Prepress operations convert the design created by the designer into the film or files that are used to engrave or etch the printing plates or cylinders (FDA, 2003).  Estimates for these setup costs are described in the next subsection (Table 4).

     Because firms have to print labels anyway, printing cost is not a cost of this rule unless firms would have to print labels before they used up their stock of printed labels.  Because firms will be allowed two years to change labels and will know in advance of two years that label changes will be required, we assume that firms will be able to plan in advance and not have any unused packaged product and label stock.

     The cost of a firm's routine label change is considered as the baseline in estimating the incremental cost of the proposed rule, because the routine re-labeling cost is part of the normal business operations in the absence of the rule.

     In the next subsection the setup costs per label change are described.
Setup Costs per Label Change  -  Baseline
     In order to successfully market their product, producers label their product with the information that they want the public to know about the product.  Thus, producers create labels, and update labels as a routine cost of doing business.

     Table 4 below summarizes the setup costs per label change.  Many products have more than one size or type of package.  Each is referred to as a stock keeping unit (SKU) (FDA, 2003).  Each SKU would have to be relabeled to comply with the new requirements.  For each type of a label change (e.g. 1-color), FDA has a low, medium, and high estimate.  Table 4 shows the low estimate for a 1-color change, the medium estimate for a 2-color change, and the high estimate for a full redesign with 6 colors, thus covering the range of cost estimates from the lowest to the highest.  The last column shows the simple average of all nine of FDA's estimates.   EPA assumes that these average costs will apply to the industry as whole (both large and small firms).  The average setup costs to re-label range from $1,282 to $14,762.

Table 4.  Setup Cost to Re-label per SKU (Stock Keeping Unit): Baseline

                                 1-color, low
                                2-color, medium
                            Full redesign, high[b]
                                  Average[c]
Administrative
                                                                          $134
                                                                          $504
                                                                          $986
                                                                          $504
Graphic design
                                                                          $336
                                                                        $1,512
                                                                        $3,360
                                                                        $1,512
Prepress a
                                                                          $353
                                                                          $765
                                                                        $3,920
                                                                        $1,389
Engraving a
                                                                          $459
                                                                        $1,374
                                                                        $6,496
                                                                        $2,229
Total
                                                                        $1,282
                                                                        $4,155
                                                                       $14,762
                                                                        $5,634
Source: FDA Labeling Cost Model (FDA, 2003) adjusted for inflation using Producer Price Index for printing of 1.12
[a] Average of flexography, offset lithograph, and rotogravure
[b] With 6 colors
c Average of all 9 of FDA estimates:  3 each of 1-color, 2-color, and full redesign.

	  Estimates in Table 4 represent the baseline costs of label change the firms routinely conduct as part of normal business operation.  In the next subsection, the costs of the proposed rule under different compliance periods are estimated.
Cost of the Proposed Rule
      The proposed rule, once final, will impose some cost to redesign the label to accommodate new EPA requirements.  The expected cost of the label change will depend on the length of the rule implementation period, which will determine the extent to which the new EPA requirements can be incorporated as part of firm's routine relabeling operations.  In a previous analysis (EPA, 2005), EPA determined that many pesticide labels routinely undergo changes every 1 to 3 years.  Based on this information, for the current cost analysis, EPA assumes that firms will routinely re-label every three years, although some firms may re-label more or less frequently.

      Also, the 2005 EPA analysis assumed that if the changes occurred during a routine label update, then one-third of the artwork cost would be due to EPA's mandate.  Applying the same assumption, EPA assumes that if the firm's routine re-labeling operation falls within the rule compliance period (that is, if the rule requirements can be fully coordinated with the firm's routine labeling change), the cost of the rule would amount to one-third of the baseline administrative and graphic design costs only.  This incremental cost is associated with complying with EPA requirements (adding common chemical names and company contact information, etc).  This is the only cost of the label change due to the rule because the rest of relabeling costs will be incurred as part of firm's normal business operations.  In Table 5, the cost estimates for this scenario range from $157 to $1,449.

      If the firm's routine relabeling cycle falls outside the rule compliance period (that is, if the rule requirements cannot be incorporated into the firm's routine labeling change), then the firm must incur the full cost of label change estimated in the previous subsection (see Table 4) plus administrative and graphic design costs would be one-third larger due to EPA's mandate.  In the first row of Table 5, the cost estimates for this scenario range from $1,439 to $16,210.  These costs are calculated by adding the one-third extra administrative and design costs to the baseline costs of a routine label change from Table 4.   This extra cost is shown in the last row of Table 5 because EPA assumes that all labels would have been routinely changed within three years without the rule.

      If the firm's routine relabeling cycle overlaps with the rule implementation period, the cost of the rule would lie between the two cases described above.  For example, if the rule implementation period is two years, two-thirds of the labels are likely to be relabeled during the rule implementation period, while one-third of the labels are likely to be relabeled ahead of their routine label change schedule because of the rule mandate (FDA, 2003).  In this case, the average cost per label is estimated to range from $584 to $6,369 (Table 5).  For example, the weighted average cost for a 1-color change is computed as $1,439*(1/3) + $157*(2/3) = $584.

      The estimated costs of the rule under different rule compliance periods are shown in Table 5.

Table 5.  Relabeling Cost per SKU (Stock Keeping Unit) under Three Rule Implementation Periods

                                 1-color, low
                                2-color, medium
                              Full redesign, high
                                   Average[1]
Immediate relabeling[2]
                                                                        $1,439
                                                                        $4,827
                                                                       $16,210
                                                                        $6,306
2-year implementation
                                                                          $584
                                                                        $2,057
                                                                        $6,369
                                                                        $2,550
3-year implementation[3]
                                                                          $157
                                                                          $672
                                                                        $1,449
                                                                          $672
Source:  EPA calculations.
[1]Average of all 9 of FDA estimates:  3 each of 1-color, 2-color, and full redesign.
[2] Does not include additional printing costs due to discarding of label stocks.
[3]Since 3 years sufficient time for  routine label changes, this row represents the cost attributable to rule if the firm would have relabeled anyway, which is 1/3 of administrative and design costs.

     If firms are required to re-label their products, additional costs could be incurred in terms of unused packaged product and label stocks that have to be discarded requiring additional printing costs to replace discarded label stocks.   However, EPA assumes that firms will be able to plan in advance and not have any unused inventory stocks, thus avoiding this cost with two or more years to comply with the label change requirements.  While these costs would occur with immediate relabeling, we have no information to estimate additional printing costs due to discarding of label stocks.  For the above reasons, we did not include this cost in our estimates.
Industry Cost
     To estimate the cost to industry of the proposed rule, the average label setup cost per SKU is multiplied by the anticipated number of label changes (the total number of SKUs).  For the industry consisting of large and small firms, we use the average re-label cost in the right hand column of Table 5.  The total number of label changes is based on the number of exempt pesticide products in the industry and the average number of SKUs per product, which depends on the number of package sizes and types per product.  Since there is no data regarding the number of SKUs per product for the minimum risk pesticide industry, EPA uses 1.53 SKUs per product from the FDA's sunscreen rule (FDA, 2011).  EPA believes that skin-applied insect repellents (approximately 10% of the total number of minimum risk products identified in this study, see Table 1) are probably similar to sunscreen products in terms of multiple packaging since both are dermal application products for humans and thus, 1.53 SKUs per product may be a reasonable estimate for these products.  However, for the other products affected by the rule there are no data regarding the number of SKUs per product, and this is a source of uncertainty in the estimation of the cost of the proposed rule.  Any information during the public comment period on the number of SKUs per product would be useful since the cost of this rule is proportional to this number.

      Using the average cost estimates from the last column of Table 5 EPA estimates the industry cost under three different rule implementation periods, assuming firms are on a three-year relabeling cycle: immediate relabeling, two years, and three years.  To estimate the cost of the rule under each implementation period, the number of SKUs per product (1.53) is multiplied by the total number of minimum risk pesticide products (757 from Table 1) to obtain the total number of SKUs (1,158), which is in turn multiplied by the average cost per SKU from the last column of Table 5.  The results are displayed in Table 6.

Table 6: Industry Cost Under Three Rule Implementation Periods

                                   Immediate
                                    2 years
                                    3 years
Total number of SKUs[a]
                                     1,158
                                     1,158
                                     1,158
Average cost per SKU label change (last column of Table 5)
                                    $6,306
                                    $2,550
                                     $672
Total cost to industry[b]
                                  $7,300,282
                                  $2,952,097
                                   $778,005
Source:  (FDA, 2003 and 2011)
[a] The total number of SKUs is equal to the SKUs per product (1.53) times the number of products (757).
[b] The total cost to industry is equal to the total number of SKUs times the average cost per SKU.

Under an implementation period of two years, the estimated industry cost is about $3 million.  As shown in Table 6, with a three-year compliance period, the cost of the rule is reduced to about $780,000.
Small Firm Impact Analysis
     The Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, requires regulators to assess the effects of regulations on small entities, including businesses, non-profit organizations, and governments.  In some instances when significant economic impacts on a substantial number of small entities are expected, agencies are also required to examine regulatory alternatives that may reduce adverse economic effects on significantly impacted small entities.

      The RFA does not define the terms "significant" or "substantial" with regards to the extent of the economic impact and number of small entities affected.  EPA has previously characterized annual incremental compliance costs of one percent of annual sales as not significant.  If costs are likely to be greater than one percent of annual sales, EPA considers both the number of affected firms and their proportion of all small firms to determine if a substantially higher number of firms will be impacted.  If costs are likely to be greater than three percent of annual sales, a smaller number and proportion of affected firms is considered substantial.
Profile of Small Businesses
      Firms are classified as small or large by the Small Business Administration (SBA).  SBA uses either the number of employees or annual gross revenue as a threshold to classify a company as small or large.  For example, the firms in the NAICS code 325: Chemical Manufacturing, the most common code for the firms producing minimum risk pesticide products are classified as small if the number of employees is less than 500, 750, or 1,000, depending on the more refined classification scheme (that is, the 6-digit NAICS code) (see Table 3).  The firms in the next most common NAICS code  -  424: Merchant Wholesalers, Nondurable Goods  -  are classified as small if the number of employees is less than 100.  The revenue threshold is used for only a few firms in the industry.  Using such SBA thresholds, it is determined that for the minimum risk pesticide industry, there are 97 small firms (out of the total 192, see Table 3), accounting for approximately 51% of the industry.  They employ on average approximately 30 employees, with average annual revenue of approximately $2.8 million. Base on this information, EPA certifies that there will not be a significant impact on a substantial number of small entities (SISNOSE).  This conclusion is based on our finding that the following criteria are met:  Fewer than 25 small businesses are likely to experience an economic impact of 1% or more of gross sales, and less than 25% of the small businesses are likely to experience an economic impact of 1% or more of gross sales.  If costs are likely to be greater than or equal to 3% of annual sales, fewer than 10 small firms, and less than 10% of the small firms are likely to experience an economic impact of such magnitude.
Estimation of Impacts on Small Businesses
      As noted above, EPA evaluates the impact of a rule on a small firm by comparing the cost to the firm with the firm's annual sales.  We first examine the likely impact to small firms on average before refining the analysis to consider those firms that may face higher than average impacts.

      The average cost to a small firm is simply the average cost of a label change multiplied by the number of labels the average firm would have to modify.  The number of labels that must be changed is estimated as the average number of products a firm markets times the average number of SKU per product.

      The average relabeling cost per SKU was estimated in the previous section and presented in the last column of Table 5.  The average cost may overestimate costs to small firms in the industry as smaller firms may be more likely than large firms to use simpler labels with one or two colors.  The 97 small firms identified in Section 4.1 market, on average, 3.8 products.  The average number of products is multiplied by the estimate of 1.53 SKUs per product (see the discussion in Section 3.2 above) to obtain the expected number of labels that the average small firm would change as a result of the rule: 5.75 labels per firm.  Table 7 presents the estimated impact, given average revenues of $2.8 million/year, under different rule implementation periods.  The impacts of the proposed rule on small firms are measured as the cost of the rule as a percent of the average small business annual revenue ($2.8 million).  Thus, the impacts are approximately 1.3%, 0.5%, and 0.1% of the average gross revenue of small firms, under each rule implementation period.  This means that under a two-year implementation period, for example, an average small firm is likely to experience the impact that is approximately 0.5% of average gross revenue.  A similar interpretation is given for the other two implementation periods.

Table 7. Small Business Impacts
                          Rule implementation period
                             Average cost per SKU
                           Average cost per firm[a]
                        Impact (% of gross revenue)[b]
                                                                      Immediate
                                                                        $6,306
                                                                       $36,189
                                                                           1.3%
                                                  With 2 years to change labels
                                                                        $2,550
                                                                       $14,634
                                                                           0.5%
                                                  With 3 years to change labels
                                                                          $672
                                                                        $3,857
                                                                           0.1%
a Cost per SKU times 5.75   SKUs per firm (3.8 products  per firm x 1.53 SKUs per product).
b Given average revenue per small firm of $2.8 million.

      Thus, for the two-year and three-year implementation periods, EPA concludes that the average small firm would not face significant impacts, based on the criteria above.  The immediate label change scenario might be a borderline case, but this scenario is very unlikely to be implemented.

      To better understand the distribution of impacts across firms, in the next section, the small business impacts are analyzed in more detail by further delineating the SBA-defined small firms into "small" and "very small" firms.
Refined Analysis
      The size of the company may influence the cost of label change.  In general, small firms might choose setup costs that are less expensive, compared to the large companies with more resources.  Thus, EPA assumes that small firms would choose either 1-color or 2-color label change schemes, and are unlikely to do a full color design of their labels.  Inspection of firm revenue data indicates that there are several small firms with very small annual revenue.  To investigate the impacts of the proposed rule on these firms more closely EPA further classified the SBA-defined small firms into "small" and "very small" firms as follows.  Since the medium cost for a 2-color label change is estimated to be $4,155 (see Table 4), which is approximately 1% of the gross revenue of a firm with gross revenue of $500,000, EPA assumes that small firms with annual revenues of $500,000 or more would, on average, choose the medium 2-color setup for their labels.  EPA also assumes that "very small" firms of less than $500,000 sales revenue would choose the low 1-color setup for their labels.

      Since the data on the number of products for each small firm is available, using the estimate of 1.53 SKUs per product for all small firms, EPA was able to estimate the total number of SKUs for each small firm.  Then, EPA computed the cost of the rule for each small firm by multiplying the appropriate (i.e., the 1-color low estimate for "very "small" and 2-color medium estimate for "small" firms) average relabeling cost per SKU from Table 5 by the total number of SKUs for each firm.  These firm-specific costs, as a percent of each firm's annual revenue, are used as a measure of the impact of the proposed rule on small businesses.

      The impacts of the proposed rule on small businesses are reported in Table 8.  With a two-year compliance period as currently proposed, 26 small firms (or 27% of all small firms) are likely to experience an economic impact of 1% or more of gross sales, and nine small firms (9% of all small firms) may incur impacts greater than or equal to 3% of gross sales.  Therefore, based on the criteria described above, EPA concludes that there will be no significant impact on a substantial number of small entities (SISNOSE)

      Because many of the firms are very small, even the modest setup cost (Table 4) can result in a large impact on small firms.  However, by allowing firms sufficient time to comply with the re-label requirements the impact on small firms can be reduced.  For example, from Table 8, if given three years to comply, the impact on small businesses can be greatly reduced.

Table 8. Small Business Impacts  -  Refined Analysis
Rule implementation period
                     Impact (% of annual gross revenue)[a]

                                    >= 1%
                                    >= 3%
Immediate
                                   64% (62)
                                   21% (21)
With 2 years to change labels
                                   27% (26)
                                    9% (9)
With 3 years to change labels
                                    7% (7)
                                    0% (0)
[a] The estimates are the percent of the small firms impacted out of 97 small firms and the
numbers in parentheses represent the number of firms impacted.
 References
Comments submitted by small businesses.  Docket EPA-HQ-OPP-2010-0305

Dun and Bradstreet, 2009. Market Spectrum Analysis.

EPA, 2005.  "Economic Analysis of the Bulk Pesticide Container Design and Residue Removal Standards." Docket EPA-HQ-OPP-2005-0327. Document ID:  EPA-HQ-OPP-2005-0327-0024

EPA, 2010.  State registration lists:  AL, AK, AZ, CO, IO, LA, MS, NH, NC, OK, RI, SC, SD, and WA.  Docket EPA-HQ-OPP-2010-0305

FDA, 2003.  FDA Labeling Cost Model.  Research Triangle Institute.

FDA, 2011.  Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use, Final Rule, June 17, 2011.  Docket ID FDA-1978-N-0018 (formerly 1978N-0038).

Nielsen Company. Scanner data on skin-applied insect repellent products. 2008.  Docket EPA-HQ-OPP-2010-0305

EPA.  State minimum risk product registrations. 2010.  Docket EPA-HQ-OPP-2010-0305


[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Notices]
[Page 16452-16453]
[DOCID:fr01ap10-56]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-912-000]

Nasdaq OMX Commodities Clearing--Contract Merchant, LLC;
Supplemental Notice That Initial Market-Based Rate Filing Includes
Request for Blanket Section 204 Authorization

March 25, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Nasdaq OMX Commodities Clearing--Contract Merchant, 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 April 14, 2010.
    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
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., 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 review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-7296 Filed 3-31-10; 8:45 am]
BILLING CODE 6717-01-P