[Federal Register: June 16, 2006 (Volume 71, Number 116)]
[Notices]
[Page 34924]
[DOCID:fr16jn06-95]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-422-000]

El Paso Natural Gas Company; Notice of Revised Date and Time of
Settlement Conference

June 9, 2006.
    On June 7, 2006, the Commission issued a ``Notice of Informal
Settlement Conference'' in the above-referenced docket for the purpose
of exploring a possible settlement. A new date and time has been
established for the informal settlement conference as follows:
    Date: June 14, 2006.
    Time: 9 a.m. (EST).
    The settlement conference will be held in Hearing Room 1, at the
Commission's offices, 888 First Street, NE., Washington, DC 20426.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-9396 Filed 6-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 245 (Friday, December 20, 2013)]
[Notices]
[Pages 77178-77181]
[FR Doc No: 2013-30266]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71081; File No. SR-ISE-2013-65]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend the Schedule of Fees

December 16, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on December 2, 2013, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission the proposed rule change, as described in Items I,
II, and III below, which items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE proposes to amend its Schedule of Fees to adjust complex
order fees and rebates. The text of the proposed rule change is
available on the Exchange's Web site (http://www.ise.com), at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange is proposing to amend its Schedule of Fees to adjust
complex order fees and rebates, including rebates

provided to Priority Customer \3\ complex orders, maker/taker fees, and
fees for responses to complex crossing orders. The fee changes
discussed apply to both Standard Options and Mini Options traded on the
Exchange. The Exchange's Schedule of Fees has separate tables for fees
applicable to Standard Options and Mini Options. The Exchange notes
that while the discussion below relates to fees for Standard Options,
the fees for Mini Options, which are not discussed below, are and shall
continue to be 1/10th of the fees for Standard Options.
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    \3\ A Priority Customer is defined in ISE Rule 100(a)(37A) as a
person or entity that is not a broker/dealer in securities, and does
not place more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s).
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    The Exchange currently provides volume-based tiered rebates for
Priority Customer complex orders when these orders trade with non-
Priority Customer orders in the complex order book.\4\ These complex
order rebates are provided to Members in six tiers based on the
Member's average daily volume (``ADV'') in Priority Customer complex
contracts. For Select Symbols (excluding SPY) this rebate is $0.33 per
contract for Members with a Priority Customer Complex ADV of fewer than
40,000 contracts (i.e., Tier 1), $0.35 per contract for Members with a
Priority Customer Complex ADV of 40,000-74,999 contracts (i.e., Tier
2), $0.37 per contract for Members with a Priority Customer Complex ADV
of 75,000-124,999 contracts (i.e., Tier 3), $0.39 per contract for
Members with a Priority Customer Complex ADV of 125,000-224,999
contracts (i.e., Tier 4), $0.40 per contract for Members with a
Priority Customer Complex ADV of 225,000-299,999 contracts (i.e., Tier
5), and $0.41 per contract for Members with a Priority Customer Complex
ADV of 300,000 contracts or more (i.e., Tier 6). For SPY the rebate is
$0.36 per contract for Tier 1, $0.38 per contract for Tier 2, $0.39 per
contract for Tier 3, $0.40 per contract for Tier 4, $0.41 per contract
for Tier 5, and $0.42 for Tier 6. And for non-Select Symbols the rebate
is $0.66 per contract for Tier 1, $0.72 per contract for Tier 2, $0.75
per contract for Tier 3, $0.77 per contract for Tier 4, $0.78 per
contract for Tier 5, and $0.79 for Tier 6. The Exchange is now
proposing to increase these rebates for Members that achieve Tier 2 or
higher as shown in the table below.
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    \4\ The Exchange offers a rebate in Standard and Mini Options
for Priority Customer complex orders in (i) Select Symbols
(excluding SPY), (ii) SPY, and (iii) Non-Select Symbols, when these
orders trade with non-Priority Customer orders in the complex order
book.

                                         Priority Customer Rebate by ADV
----------------------------------------------------------------------------------------------------------------
                                                           Select symbols       Non-select
             Priority customer complex ADV                (excluding SPY)        symbols              SPY
----------------------------------------------------------------------------------------------------------------
Tier 1; 0-39,999.......................................            ($0.33)            ($0.66)            ($0.36)
Tier 2; 40,000-74,999..................................            ($0.37)            ($0.75)            ($0.40)
Tier 3; 75,000-124,999.................................            ($0.39)            ($0.78)            ($0.41)
Tier 4; 125,000-224,999................................            ($0.41)            ($0.80)            ($0.42)
Tier 5; 225,000-299,999................................            ($0.43)            ($0.83)            ($0.44)
Tier 6; 300,000+.......................................            ($0.44)            ($0.84)            ($0.45)
----------------------------------------------------------------------------------------------------------------

    The Exchange also provides volume-based tiered rebates to Priority
Customer Complex orders that trade with quotes and orders on the
regular order book.\5\ For all symbols (excluding SPY) this rebate is
$0.06 per contract for Tier 1, $0.12 per contract for Tier 2, $0.13 per
contract for Tier 3, $0.17 per contract for Tier 4, $0.18 per contract
for Tier 5, and $0.19 per contract for Tier 6. For SPY the rebate is
$0.07 per contract for Tier 1, $0.13 per contract for Tier 2, $0.14 per
contract for Tier 3, $0.18 per contract for Tier 4, $0.19 per contract
for Tier 5, and $0.20 per contract for Tier 6. Like the rebates
discussed above for Priority Customer complex orders that trade with
non-Priority Customer orders in the complex order book, the Exchange is
also proposing to increase the rebate for Priority Customer Complex
orders that trade with quotes and orders on the regular order book for
Members that achieve Tier 2 or higher as shown in the table below.
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    \5\ The Exchange offers a rebate in Standard and Mini Options
for Priority Customer complex orders that trade with quotes and
orders on the regular order book in (i) SPY, and (ii) other symbols
excluding SPY.

                     Priority Customer Rebate by ADV
 [For Orders that Trade with Quotes and Orders on the Regular Orderbook]
------------------------------------------------------------------------
                                       All symbols
   Priority customer complex ADV     (excluding SPY)          SPY
------------------------------------------------------------------------
Tier 1; 0-39,999..................            ($0.06)            ($0.07)
Tier 2; 40,000-74,999.............            ($0.14)            ($0.15)
Tier 3; 75,000-124,999............            ($0.15)            ($0.16)
Tier 4; 125,000-224,999...........            ($0.19)            ($0.20)
Tier 5; 225,000-299,999...........            ($0.21)            ($0.22)
Tier 6; 300,000+..................            ($0.22)            ($0.23)
------------------------------------------------------------------------

    The Exchange also charges fees for adding liquidity, i.e., maker
fees, to non-Priority Customers complex orders when trading against
Priority Customer complex orders,\6\ and fees for removing liquidity,
i.e., taker fees, regardless of the counterparty. In particular, the
Exchange charges Market Maker \7\ orders a fee of $0.39 per contract in
Select Symbols (excluding SPY) and SPY, and a fee of $0.82 per contract
in non-Select Symbols. For Non-ISE Market Maker,\8\

Firm Proprietary/Broker Dealer,\9\ and Professional Customer \10\
orders the Exchange charges a fee of $0.40 per contract for Select
Symbols (excluding SPY), $0.41 per contract for SPY, and $0.84 per
contract in non-Select Symbols. The Exchange is now proposing to
increase the fees for market participants that remove liquidity or
provide liquidity to a Priority Customer complex order as follows. The
Exchange is proposing to increase the fee for Market Maker orders to
$0.42 per contract in Select Symbols (excluding SPY),\11\ $0.43 per
contract in SPY, and $0.85 per contract in non-Select Symbols. For Non-
ISE Market Maker, Firm Proprietary/Broker Dealer, and Professional
Customer orders the Exchange proposes to increase the fee to $0.44 per
contract in Select Symbols (excluding SPY), $0.45 per contract in SPY,
and $0.87 per contract in non-Select Symbols. The Exchange is not
proposing to change the maker fees for market participants that do not
trade against Priority Customer complex orders.
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    \6\ The Exchange separately charges maker fees for non-Priority
Customer complex orders that do not trade against Priority Customer
complex orders. These fees are not discussed in this filing.
    \7\ The term ``Market Makers'' refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively. See ISE Rule
100(a)(25).
    \8\ A Non-ISE Market Maker, or Far Away Market Maker
(``FarMM''), is a market maker as defined in Section 3(a)(38) of the
Securities Exchange Act of 1934, as amended, registered in the same
options class on another options exchange.
    \9\ A Firm Proprietary order is an order submitted by a Member
for its own proprietary account. A Broker-Dealer order is an order
submitted by a Member for a non-Member broker-dealer account.
    \10\ A Professional Customer is a person who is not a broker/
dealer and is not a Priority Customer.
    \11\ The Exchange notes that complex order quoting is currently
permitted in the following symbols: AA, ABX, EFA, GLD, MSFT, MU,
NVDA, VXX, VZ, WFC, XLB and XOP (``Complex Quoting Symbols''). This
proposed rate change also applies to Market Maker quotations in
Complex Quoting Symbols when trading against Priority Customer
complex orders.
---------------------------------------------------------------------------

    Finally, the Exchange charges a fee for responses to complex
crossing orders, which are similar to the Exchange's taker rates
described above. The Exchange is proposing to increase the fees for
responses to complex crossing orders to keep them at levels generally
in line with the proposed taker fees. In Select Symbols the fee for
responses to complex crossing orders is $0.40 per contract for all
market participants, including Priority Customers. The Exchange
proposes to increase this fee to $0.44 per contract. In non-Select
Symbols the fee for responses to complex crossing orders is $0.82 per
contract for Market Maker orders, and $0.84 per contract for Non-ISE
Market Maker, Firm Proprietary/Broker Dealer, and Professional Customer
orders. The Exchange proposes to increase this fee to $0.87 per
contract for all non-Priority Customer orders. The Exchange will
continue to not charge a fee to Priority Customers for responses to
complex crossing orders in non-Select Symbols.
 2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\12\ in general, and
Section 6(b)(4) of the Act,\13\ in particular, in that it is designed
to provide for the equitable allocation of reasonable dues, fees, and
other charges among its members and other persons using its facilities.
The complex order pricing employed by the Exchange has proven to be an
effective pricing mechanism, and attractive to Members. The Exchange
believes that this proposed rule change will continue to attract
additional complex order business to the ISE.
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    \12\ 15 U.S.C. 78f.
    \13\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that it is reasonable, equitable, and not
unfairly discriminatory to increase the rebate paid to Priority
Customer complex orders that trade with non-Priority Customer orders in
the complex order book, or trade with quotes and orders on the regular
order book, because paying these increased rebates will continue to
attract additional order flow to the ISE and create liquidity which
will ultimately benefit all market participants who trade on the
Exchange. The Exchange believes that providing higher rebates to
Priority Customer complex orders, and in particular Priority Customer
orders from Members that have achieved specified volume thresholds,
will encourage Members to route additional Priority Customer complex
orders to the Exchange in order to qualify for the new rebates, and
thereby help the Exchange remain competitive with other options
exchanges in attracting this order flow.
    The Exchange further believes that it is reasonable, equitable, and
not unfairly discriminatory to increase its maker/taker and response
fees as the Exchange is seeking to recoup the cost associated with the
proposed Priority Customer rebates. In order to maintain these fees at
similar levels the Exchange is proposing to move the maker/taker and
response fees in tandem. As stated above, the Exchange believes that
the increased Priority Customer rebates being supported by these maker/
taker and response fees will attract Priority Customer order flow to
the Exchange to the benefit of all market participants. The Exchange
notes that the proposed maker/taker and response fees are consistent
with fee structures and price differentials that exist today at other
options exchanges, and does not believe that it is unfairly
discriminatory to continue to provide a rebate to Priority Customer
orders while charging a fee to non-Priority Customer orders as
discussed in this filing. A Priority Customer is by definition not a
broker or dealer in securities, and does not place more than 390 orders
in listed options per day on average during a calendar month for its
own beneficial account(s). This limitation does not apply to
participants on the Exchange whose behavior is substantially similar to
that of market professionals, including Professional Customers, who
will generally submit a higher number of orders (many of which do not
result in executions) than Priority Customers.
    The Exchange notes that it has determined to charge fees in Mini
Options at a rate that is 1/10th the rate of fees the Exchange provides
for trading in Standard Options. The Exchange believes it is reasonable
and equitable and not unfairly discriminatory to assess lower fees to
provide market participants an incentive to trade Mini Options on the
Exchange. The Exchange believes the proposed fees are reasonable and
equitable in light of the fact that Mini Options have a smaller
exercise and assignment value, specifically 1/10th that of a standard
option contract, and, as such, is providing fees that are 1/10th of
those applicable to Standard Options.

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

    In accordance with Section 6(b)(8) of the Act,\14\ the Exchange
does not believe that the proposed rule change will impose any burden
on intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. To the contrary,
the Exchange believes that the proposed changes will promote
competition as they are designed to allow the ISE to better compete for
order flow and improve the Exchange's competitive position by offering
higher rebates to Members that execute a large volume of Priority
Customer complex orders. While the Exchange is increasing the maker/
taker and response fees the Exchange does not believe that this will
impose a burden on competition because the new fees are consistent with
the Exchange's current fee structure and with the fee structures of
other options exchanges. The Exchange operates in a highly competitive
market in which market participants can readily direct their order flow
to competing venues. In such an environment, the Exchange must
continually review, and consider adjusting, its fees and rebates to
remain competitive with other exchanges. For

the reasons described above, the Exchange believes that the proposed
fee changes reflect this competitive environment.
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    \14\ 15 U.S.C. 78f(b)(8).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \15\ and subparagraph (f)(2) of Rule 19b-4
thereunder,\16\ because it establishes a due, fee, or other charge
imposed by ISE.
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    \15\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \16\ 17 CFR 240.19b-4(f)(2).
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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 to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2013-65 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2013-65. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2013-65 and should be
submitted on or before January 10, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
Kevin M. O'Neill,
Deputy Secretary.
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    \17\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2013-30266 Filed 12-19-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 75 (Tuesday, April 19, 2011)]
[Notices]
[Page 21932]
[FR Doc No: 2011-9413]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64226A; File No. SR-FINRA-2011-005]

 Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Order Granting Approval of a Proposed Rule Change
Relating to Promissory Note Proceedings; Correction

April 13, 2011.

Need for Correction

    In FR Document No. 2011-8897 beginning on page 20741 as published
on Wednesday, April 13, 2011, the Commission issued Release No. 34-
64226, an order approving the proposed rule change by the Financial
Industry Regulatory Authority, Inc. (``FINRA'') to amend Rule 13806 of
the Code of Arbitration Procedure for Industry Disputes (``Industry
Code''). Commission staff discovered that a statement in the
introduction section of that order mischaracterized the nature of the
rule change which was described accurately in the remainder of the
order. The staff believes this mischaracterization was the result of an
editing error.
    This correction does not substantively amend the Commission's
approval order. The sole purpose of this correction is to rectify the
error in the introduction section and alleviate any potential
confusion. The introduction section of this approval order is being
republished with the correction.

Correction of Publication

    Accordingly, the Introduction of the approval order is republished
to correct a statement therein, as follows:

I. Introduction

    On February 4, 2011, the Financial Industry Regulatory Authority,
Inc. (``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Rule 13806 of the Code of Arbitration
Procedure for Industry Disputes (``Industry Code'') to provide that
FINRA will appoint a chair-qualified public arbitrator to a panel
resolving a promissory note dispute instead of a chair-qualified public
arbitrator also qualified to resolve a statutory discrimination claim.
The proposed rule change was published for comment in the Federal
Register on February 22, 2011.\3\ The Commission did not receive any
comments on the proposal. This order approves the proposed change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities and Exchange Act Release No. 63909 (February
15, 2011), 76 FR 9838 (February 22, 2011) (``Notice'').

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\4\
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    \4\ 17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-9413 Filed 4-18-11; 8:45 am]
BILLING CODE 8011-01-P


63424 Federal Register / Vol. 67, No. 198 / Friday, October 11, 2002 / Notices B. What is the Agency's Authority for Taking this Action? The legal authority for this action falls under FIFRA, as amended in 1988 and 1996. Section 4( g)( 2)( A) of FIFRA directs that, after submission of all data concerning a pesticide active ingredient, `` the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration, '' before calling in product specific data on individual enduse products, and either reregistering products or taking `` other appropriate regulatory action. ''

List of Subjects Environmental protection, Chemicals, Pesticides and pests.

Dated: September 24, 2002. Lois Ann Rossi, Director, Special Review and Reregistration Division, Registration Division, Office of Pesticide Programs. [FR Doc. 02– 25861 Filed 10– 10– 02; 8: 45 am]

BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [OPP– 2002– 0261; FRL– 7275– 9]

Notice of Receipt of Requests for Amendments to Delete Uses in Certain Pesticide Registrations 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 for amendments by registrants to delete uses in certain pesticide registrations. 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 amended to delete one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any request on the Federal Register. DATES: The deletions are effective on April 9, 2003, or on November 12, 2002, for products with registration numbers 007401– 00267, 062719– 00081, and 062719– 84, unless the Agency receives a withdrawal request on or before April 9, 2003, or on before November 12, 2002, for products with registration numbers 007401– 00267, 062719– 00081, and 062719– 00084. Users of these products who desire continued use on crops or sites being deleted should contact the applicable registrant on or before dates given above.

ADDRESSES: Withdrawal requests may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP– 2002– 0261 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: James A. Hollins, Office of Pesticide Programs (7502C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (703) 305– 5761; e mail address: hollins. james@ 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 ID number OPP– 2002– 0261. 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 applications from registrants to delete uses in certain pesticide registrations. These registrations are listed in the following Table 1 by registration number, product name/ active ingredient, and specific uses deleted:

TABLE 1.— REGISTRATIONS WITH REQUESTS FOR AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE REGISTRATIONS Registration Number Product Name Active Ingredient Delete from Label 006959– 00092 Cesso Fire Ant Killer Piperonyl butoxide; tetramethrin; permethrin, mixed cis, trans Indoor uses and use on outside surfaces of buildings 007401– 00267 Hi Yield 5% Malathion Dust Malathion dust Use on corn 062719– 00081 Lontrel F Technical Clopyralid Residential turf 062719– 00084 Lontrel 35A Clopyralid Residential turf VerDate 0ct< 02> 2002 22: 29 Oct 10, 2002 Jkt 200001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 11OCN1. SGM 11OCN1 63425 Federal Register / Vol. 67, No. 198 / Friday, October 11, 2002 / Notices TABLE 1.— REGISTRATIONS WITH REQUESTS FOR AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE REGISTRATIONS— Continued Registration Number Product Name Active Ingredient Delete from Label 062719– 00330 Esteron 638 2,4 Dichlorophenoxyacetic acid, 2 butoxyethyl ester Cereals underseeded with legumes, orchard floors and sugarcane Users of these products who desire continued use on crops or sites being deleted should contact the applicable registrant before dates indicated in DATES section of this notice to discuss withdrawal of the application for amendment. This 180– day period, or 30– day where indicated, will also permit interested members of the public to intercede with registrants prior to the Agency's approval of the deletion. Table 2 includes the names and addresses of record for all registrants of the products in Table 1, in sequence by EPA company number.

TABLE 2.— REGISTRANTS REQUESTING AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE REGISTRATIONS EPA Company Number Company Name and Address 006959 Cessco Inc. 3609A River Road Johns Island, SC 29455 007401 Brazos Associates Inc. Agent For: Voluntary Purchasing Group Inc. 2001 Diamond Ridge Drive Carrollton, TX 75010 062719 Dow Agrosciences LLC. 9330 Zionsville Road 308/ 2E225 Indianapolis, IN 46268 III. What is the Agency 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 amended to delete one or more uses. The Act 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 use deletion must submit such withdrawal in writing to James A. Hollins, at the address under FOR FURTHER INFORMATION CONTACT, postmarked on or before April 9, 2003, or on or before November 12, 2002, for products with registration numbers 007401– 00267, 062719– 00081, and 062719– 00084.

V. Provisions for Disposition of Existing Stocks The Agency has authorized the registrants to sell or distribute product under the previously approved labeling for a period of 18 months after approval of the revision, unless other restrictions have been imposed, as in special review actions. There is a 12– month existing stocks provision for Dow AgroSciences, EPA registration numbers 062719– 00081, and 062719– 00084, after approval of revised label.

List of Subjects Environmental protection, Pesticides and pests.

Dated: September 23, 2002. Linda Vlier Moos, Acting Director, Information Resources and Services Division, Office of Pesticide Programs. [FR Doc. 02– 25423 Filed 10– 10– 02; 8: 45 am]

BILLING CODE 6560– 50– S OFFICE OF NATIONAL DRUG CONTROL POLICY Appointment of Members of Senior Executive Services Performance Review Board AGENCY: Office of National Drug Control Policy (ONDCP).

ACTION: Notice of Appointments.

SUMMARY: The following persons have been appointed to the ONDCP Senior Executive Service Performance Review Board: Dr. Albert E. Brandenstein; Mr. Robert Brown; Mr. Norman R. Deck; and Mr. Edward H. Jurith. FOR FURTHER INFORMATION CONTACT: Please direct any questions to Linda V. Priebe, Assistant General Counsel (202) 395– 6622, Office of National Drug Control Policy, Executive Office of the President, Washington, DC 20503.

Linda V. Priebe, Assistant General Counsel. [FR Doc. 02– 25933 Filed 10– 10– 02; 8: 45 am]

BILLING CODE 3180– 02– M FEDERAL EMERGENCY MANAGEMENT AGENCY [FEMA– 1435– DR]

Louisiana; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency (FEMA). ACTION: Notice.

SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Louisiana (FEMA– 1435– DR), dated September 27, 2002, and related determinations.

EFFECTIVE DATE: September 27, 2002.

FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Response and Recovery Directorate, Federal Emergency Management Agency, Washington, DC 20472, (202) 646– 2705 or Magda. Ruiz@ fema. gov.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated September 27, 2002, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U. S. C. 5121– 5206 (Stafford Act), as follows:

I have determined that the damage in certain areas of the State of Louisiana, resulting from Tropical Storm Isidore beginning on September 21, 2002, and continuing is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U. S. C. 5121– 5206 (Stafford Act). I, therefore, declare that such a major disaster exists in the State of Louisiana. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes, such amounts as you find necessary for Federal disaster assistance and administrative expenses.

VerDate 0ct< 02> 2002 22: 29 Oct 10, 2002 Jkt 200001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 11OCN1. SGM 11OCN1


TELEPHONE CALL RECORD Incoming Call _ Outgoing Call Account & Task Number Project Name Date 7/ 27/ 05 Time 11: 30 Person Calling Amy Schaffer, Federal Regulatory Affairs Manager Weyerhaeuser Activity Person Called Bryan Lange, Engineer ERG Telephone No.

( 202) 293 7222 General Subject Discussion of June 27, 2005 Memorandum Regarding Minimum Monitoring Requirements.

TOPICS DISCUSSED AND ACTION TAKEN EPA, through an information collection request ( ICR) solicited comment on monitoring requirements and burden of information collection. EPA ICR Number 1878.02, OMB Control Number 2040 0243: 70 Fed. Reg. 30439 ( May 26, 2005).

Don Anderson ( EPA/ EAD) received a submittal from Jerry Schwartz of AF& PA to the EPA Docket Control Center. This memorandum presents the monitoring data at several Phase I mills. The memorandum and four attachments were forwarded to ERG.

I contacted Amy Schaffer ( Weyerhaeuser's Federal Regulatory Affairs Manager) to discuss two statements made in the Weyerhaeuser attachment to the Jerry Schwartz memorandum. I explained to Amy Schaffer that I was confused by two statements. First: " In no instance did the daily maximum monitoring show the effluent to be above the effluent limitation."

PCS data not agree. The monthly data showed that the Columbus Pulp and Paper Complex in Mississippi reported a single chlorinated phenolic compound measurement of 121 ug/ L at the Bleach Plant Effluent to Sewer System ( DSCH: 003) on 12/ 31/ 04 ( pentachlorophenol; PRAM: 39032). Amy Schaffer, after discussing the data with her contacts at the mill, replied that the detected chlorinated phenolic compound reported in PCS was an error. For the past several months the mill has been working with the state to remove that error. All corrections have been made to the detailed study report.

Contunied below:

Signature: I also explained PCS monthly data shows a second mill ( Port Wentworth) with elevated chlorinated phenolic compounds: 3,4,5 trichlorocatechol ( PRAM: 73037) and 3,4,6 trichloroguaiacol ( PRAM: 51022 at the Bleach Plant Effluent ( DSCH: 006). The reported concentrations are 1,000 times the method ML, the units reported to PCS may be incorrect. Amy Schaffer forwarded the questions to her contacts at the mill. As of August 8th no response has been received from Amy Schaffer or Port Wentworth mill representatives.

I explained to Amy Schaffer that a second statement in the memorandum also had me confused: " Weyerhaeuser Company has three pulp and paper mills that are subject to EPA's Cluster Rule..."

Amy Schaffer explained that three mills permits include all Cluster Rules monitoring requirements ( Columbus, MS; New Bern; NC; and Longview, WA). All other Weyerhaeuser mills, that do not yet have final permits which include Cluster Rules limits, but have been pro actively monitoring for Cluster Rule pollutants and meeting the guidelines. Results of monitoring that is not required by NPSES permits not necessarily submitted to PCS.


[Federal Register Volume 81, Number 28 (Thursday, February 11, 2016)]
[Notices]
[Pages 7360-7361]
[FR Doc No: 2016-02779]

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

Coast Guard

[Docket No. USCG-2016-0056]

National Offshore Safety Advisory Committee

AGENCY: Coast Guard, DHS.

ACTION: Notice of Federal Advisory Committee meeting.

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SUMMARY: The National Offshore Safety Advisory Committee and its
Subcommittees will hold meetings in New Orleans, LA to discuss the
safety of operations and other matters affecting the offshore oil and
gas industry. These meetings are open to the public.

DATES: Subcommittees of the National Offshore Safety Advisory Committee
will meet on Tuesday, March 29, 2016 from 1 p.m. to 4 p.m. and the full
Committee will meet on Wednesday, March 30, 2016, from 8:30 a.m. to
5:30 p.m. (All times are Central Standard Time). These meetings may end
early if the Committee has completed its business, or they may be
extended based on the number of public comments.

ADDRESSES: The meetings will be held at the Omni Riverfront Hotel at
701 Convention Center Blvd., New Orleans, LA 70130,<PHONE_NUMBER>,
http://www.omnihotels.com/hotels/new-orleans-riverfront.
    For information on facilities or services for individuals with
disabilities, or to request special assistance at the meetings, contact
the individuals listed in FOR FURTHER INFORMATION CONTACT section, as
soon as possible.
    To facilitate public participation, we are inviting public comment
on the issues to be considered by the Committee as listed in the
``Agenda'' section below. Written comments for distribution to
Committee members must be submitted no later than March 16, 2016, if
you want the Committee members to be able to review your comments
before the meeting, and must be identified by docket number USCG-2016-
0056. Written comments may be submitted using the Federal e-Rulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review a Privacy Act notice regarding the Federal Docket Management
System in the March 24, 2005, issue of the Federal Register (70 FR
15086).
    Docket: For access to the docket or to read documents or comments
related to this notice, go to http://www.regulations.gov, insert USCG-
2016-0056 in the Search box, press Enter, and then click on the item
you wish to view.
    A public oral comment period will be held during the meeting on
March 30, 2016, and speakers are requested to limit their comments to 3
minutes. Contact one of the individuals listed below to register as a
speaker.

FOR FURTHER INFORMATION CONTACT: Commander Jose Perez, Designated
Federal Officer of the National Offshore Safety Advisory Committee,
Commandant (CG-OES-2), U.S. Coast Guard, 2703 Martin Luther King Jr.
Avenue SE. Stop 7509, Washington, DC 20593-7509; telephone (202) 372-
1410, fax<PHONE_NUMBER> or email<EMAIL_ADDRESS>or Mr. Pat
Clark, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER> or email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, Title 5 United States Code Appendix.
The National Offshore Safety Advisory Committee provides advice and
recommendations to the Department of Homeland Security on matters and
actions concerning activities directly involved with or in support of
the exploration of offshore mineral and energy resources insofar as
they relate to matters within U.S. Coast Guard jurisdiction.
    A copy of all meeting documentation will be available at https://homeport.uscg.mil/nosac no later than March 16, 2016. Alternatively,
you may contact Mr. Pat Clark as noted in the FOR FURTHER INFORMATION
CONTACT section above.

Agenda

Day 1

    The National Offshore Safety Advisory Subcommittee on Cyber
Security on the Outer Continental Shelf will meet on March 29, 2016
from 1 p.m. to 2 p.m. to review, discuss, and formulate
recommendations. Following this Subcommittee meeting, the Towing of
Mobile Offshore Drilling Unit Subcommittee will meet from 2:00 p.m. to
3:00 p.m. and then the Well Intervention Subcommittee will meet from
3:00 p.m. to 4:00 p.m.

Day 2

    The National Offshore Safety Advisory full Committee will hold a
public meeting on March 30, 2016 from 8:30 a.m. to 5:30 p.m. to review
and discuss the progress of the Subcommittees and any reports and
recommendations received from the above listed Subcommittees from their
deliberations on March 29, 2016. The Committee will then use this
information and consider public comments in formulating recommendations
to the U.S. Coast Guard. Public comments or questions will be taken at
the discretion of the Designated Federal Officer during the discussion
and recommendation portions of the meeting and during the public
comment period, see Agenda item (6).
    A complete agenda for March 30, 2016 Committee meeting is as
follows:
    (1) Welcoming remarks.
    (2) General Administration; swear in new members and accept minutes
from November 2015 National Offshore Safety Advisory Committee public
meeting.
    (3) Current Business--Presentation and discussion of updates and
any final reports to include recommendations

from the Subcommittees on Cyber Security, Towing of Mobile Offshore
Drilling Units and Well Intervention.
    (4) New Business
    (a) Discussion of any new business items.
    (5) Presentations and discussions on the following matters:
    (a) Actions on previous National Offshore Safety Advisory Committee
recommendations to the Coast Guard;
    (b) DP Assurance--vessels conducting Critical Activity Modes (CAMO)
and Well Intervention Activities;
    (c) Update from the International Association of Drilling
Contractors; and
    (d) Update on activities from the Eighth Coast Guard District's
Officer in Charge of Marine Inspection for the Outer Continental Shelf.
    (6) Public comment period.
    The agenda, any draft final reports, new task statements and
presentations will be available by March 16, 2016 at the https://homeport.uscg.mil/nosac Web site or by contacting Mr. Pat Clark in the
FOR FURTHER INFORMATION CONTACT.

Minutes

    Meeting minutes from this public meeting will be available for
public view and copying within 90 days following the close of the
meeting at the https://homeport.uscg.mil/nosac Web site.

    Dated: February 4, 2016.
J. G. Lantz,
Director of Commercial Regulations and Standards, United States Coast
Guard.
[FR Doc. 2016-02779 Filed 2-10-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Page 13396]
[FR Doc No: 2013-04564]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

90th Meeting: RTCA Special Committee 159, Global Positioning
Systems (GPS)

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

ACTION: Meeting Notice of RTCA Special Committee 159, RTCA Special
Committee 159, Global Positioning Systems (GPS)

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

SUMMARY: The FAA is issuing this notice to advise the public of the
eighty-ninth meeting of the RTCA Special Committee 159, Global
Positioning Systems (GPS).

DATES: The meeting will be held March 12-15, 2013 from 9:00 a.m.-4:30
p.m.

ADDRESSES: The meeting will be held at RTCA, Inc., 1150 18th Street
NW., Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 330-
0652/(202) 833-9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 159. The agenda will
include the following:

Working Group Sessions

March 12

     Working Group 2, GPS/SBAS, MacIntosh-NBAA Room and Colson
Board Room.

March 13

     9:00 a.m.-12:00 p.m., Working Group 2, GPS/SBAS, A4A Room.
     1:00 p.m.-5:00 p.m., Working Group 4, Precision Landing
Guidance, GPS/GBAS, MacIntosh-NBAA Room and Colson Board Room.

March 14

     Working Group 4, Precision Landing Guidance, GPS/GBAS,
MacIntosh-NBAA Room and Colson Board Room.
     1:00 p.m-5:00 p.m., Working Group 7, GPS/Antennas, A4A
Room.

March 15, 2013

     Chairman's Introductory Remarks.
     Approval of Summary of the Eighty-Ninth Meeting held
October 5, 2012.
     Review Working Group (WG) Progress and Identify Issues for
Resolution.
     GPS/3nd Civil Frequency (WG-1).
     GPS/WAAS (WG-2).
     GPS/GLONASS (WG-2A).
     GPS/Inertial (WG-2C).
     GPS/Precision Landing Guidance (WG-4).
     GPS/Airport Surface Surveillance (WG-5).
     GPS/Interference (WG-6).
     GPS/Antennas (WG-7).
     Review of EUROCAE Activities.
     Assignment/Review of Future Work.
     Other Business.
     Date and Place of Next Meeting.
     Adjourn.
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on February 21, 2013.
Paige Williams,
Management Analyst, NextGen, Business Operations Group, Federal
Aviation Administration.
[FR Doc. 2013-04564 Filed 2-26-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Proposed Rules]
[Pages 72838-72840]
[FR Doc No: 2013-28978]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2013-N-1524]

Bulk Drug Substances That May Be Used To Compound Drug Products
in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic
Act, Concerning Outsourcing Facilities; Request for Nominations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; request for nominations.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is preparing
to develop a list of bulk drug substances (bulk drugs) that may be used
to compound drug products in accordance with section 503B of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), concerning
outsourcing facilities. To identify candidates for this bulk drugs
list, interested groups and individuals may nominate specific bulk drug
substances, and FDA is describing the information that should be
provided to the Agency in support of each nomination.

DATES: Submit either electronic or written nominations for the bulk
drug substances list by March 4, 2014.

ADDRESSES: You may submit nominations, identified by Docket No. FDA-
2013-N-1524, by any of the following methods.

Electronic Submissions

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

Written Submissions

    Submit written nominations in the following ways:
     Mail/Hand delivery/Courier (for paper 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-2013-N-1524 for this request for nominations. All
nominations received may be posted without change to http://www.regulations.gov, including any personal information provided. For
additional information on submitting nominations, see the ``Request for
Nominations'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
nominations received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marissa Chaet Brykman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Suite 5100, Silver Spring, MD 20993-0002,
301-796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Quality and Security Act (DQSA) adds a new section 503B to
the FD&C Act (21 U.S.C. 353b) that creates a new category of
``outsourcing facilities.'' \1\ Outsourcing facilities, as defined in
section 503B of the FD&C Act, are facilities that meet certain
conditions described in section 503B, including registering with FDA as
an outsourcing facility. If these conditions are satisfied, a drug
compounded by or under the direct supervision of a licensed pharmacist
in an outsourcing facility is exempt from two sections of the FD&C Act:
(1) Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of
drugs with adequate directions for use) and (2) section 505 (21 U.S.C.
355) (concerning the approval of human drug products under new drug
applications (NDAs) or abbreviated new drug applications (ANDAs)); but
not section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current
good manufacturing practice for drugs).
---------------------------------------------------------------------------

    \1\ The DQSA also removes from section 503A of the FD&C Act the
provisions that had been held unconstitutional by the U.S. Supreme
Court in 2002. See Thompson v. Western States Med. Ctr., 535 U.S.
357 (2002).
---------------------------------------------------------------------------

    One of the conditions in section 503B of the FD&C Act that must be
satisfied to qualify for the exemptions is that an outsourcing facility
does not compound using a bulk drug substance unless: (1) The bulk drug
substance appears on a list established by the Secretary identifying
bulk drug substances for which there is a clinical need, or the drug
compounded from such bulk drug substance appears on the drug shortage
list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at
the time of compounding, distribution, and dispensing; (2) ``if an
applicable monograph exists under the United States Pharmacopeia, the
National Formulary, or another compendium or pharmacopeia recognized by
the Secretary for purposes of this paragraph, the bulk drug [substance
complies] with the monograph;'' (3) the bulk drug substance is
manufactured by an establishment that is registered under section 510
of the FD&C Act (21 U.S.C. 360); and (4) the bulk drug substance is
accompanied by a valid certificate of analysis (see section 503B(a)(2)
of the FD&C Act).
    Section 503B of the FD&C Act refers to the definition of ``bulk
drug substance'' in FDA regulations at 21 CFR 207.3(a)(4): ``any
substance that is represented for use in a drug and that, when used in
the manufacturing, processing, or packaging of a drug, becomes an
active ingredient or a finished dosage form of the drug, but the term
does not include intermediates used in the synthesis of such
substances'' (see section 503B(a)(2)).

II. Request for Nominations

    To identify candidates for this list, FDA is seeking public input
in the form of specific bulk drug nominations. All interested groups
and individuals may nominate specific bulk drug substances for
inclusion on the list.
    Nominations should include the following information about the bulk
drug substance being nominated and the product(s) that will be
compounded using such substance, and any other relevant information
available. If the information requested is unknown or unavailable, that
fact should be noted accordingly.

Bulk Drug Substance

     Ingredient name;
     Chemical name;
     Common name(s);
     Chemical grade or description of the strength, quality,
and purity of the ingredient;
     Information about how the ingredient is supplied (e.g.,
powder, liquid);
     Information about recognition of the substance in foreign
pharmacopeias and the status of its registration(s) in other countries,
including whether information has been submitted to USP for
consideration of monograph development;
     A bibliography of available safety and efficacy data,\2\
including any relevant peer-reviewed medical literature; and
---------------------------------------------------------------------------

    \2\ FDA recognizes that the available safety and efficacy data
supporting consideration of a bulk drug substance for inclusion on
the list may not be of the same type, amount, or quality as is
required to support an NDA.
---------------------------------------------------------------------------

     An explanation of why there is a clinical need to compound
from the bulk drug substance.

Compounded Product

     Information about the dosage form(s) into which the drug
substance will be compounded (including formulations);
     Information about the strength(s) of the compounded
product(s);
     Information about the anticipated route(s) of
administration of the compounded product(s);
     Information about the past and proposed use(s) of the
compounded product(s), including the rationale for its use or why the
compounded product(s), as opposed to an FDA-approved product, is
necessary; and
     Available stability data for the compounded product(s).
    FDA cannot guarantee that all drugs nominated during the nomination
period will be considered for inclusion on the next published bulk
drugs list. Nominations received during the nomination period that are
supported by the most complete and relevant information will likely be
evaluated first. Nominations that are not evaluated during this first
phase will receive consideration for list amendments, because the
development of this list will be an ongoing process. Individuals and
organizations also will be able to petition FDA to make additional list
amendments after the list is published.
    Interested persons may submit either electronic nominations to
http://www.regulations.gov or written nominations to the Division of
Dockets Management (see ADDRESSES). It is only necessary to send one
set of nominations. Identify nominations with the docket number found
in brackets in the heading of this document. Received nominations 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.

    Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28978 Filed 12-2-13; 11:15 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Notices]
[Page 73486]
[FR Doc No: 2012-29659]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3352-EM; Docket ID FEMA-2012-0002]

District of Columbia; Amendment No. 2 to Notice of an Emergency
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the District of Columbia (FEMA-3352-EM), dated October 28, 2012, and
related determinations.

DATES: Effective Date: November 8, 2012.

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

SUPPLEMENTARY INFORMATION: The notice of an emergency declaration for
the District of Columbia is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared an emergency by the President in his declaration of
October 28, 2012.

    The District of Columbia for emergency protective measures
(Category B), including direct federal assistance, under the Public
Assistance program.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-29659 Filed 12-7-12; 8:45 am]
BILLING CODE 9111-23-P


Page 1 of 8 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 TXR No. 0054130 MEMORANDUM DATE: March 17, 2006 SUBJECT: Human Studies Review Board: Final Weight of Evidence Comparison of Human and Animal Toxicology Studies and Endpoints for Hydrogen Cyanide Human Health Risk Assessment.

DP Barcode: 327266 PC Code: 099801 FROM: Ray Kent, Ph. D., Chief Reregistration Branch 4 Health Effects Division ( 7509C)

William Dykstra, Toxicologist Reregistration Branch 4 Health Effects Division ( 7509C)

TO: Tina E. Levine, Ph. D., Director Health Effects Division ( 7509C)

This document presents the rationale for the selection of an acute dietary endpoint and point of departure for hydrogen cyanide based on data in two human studies ( MRIDs 46769601 and 46769602). OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES Page 2 of 8 Background. One of the pesticides currently undergoing reregistration and tolerance reassessment is hydrogen cyanide. Although cyanide compounds have been used for fumigation of a variety of commodities in the past, the only remaining use on food for cyanide compounds in the United States is a post harvest fumigant use of sodium cyanide for citrus grown in California and shipped to Arizona. In the course of fumigation with sodium cyanide, hydrogen cyanide ( HCN), a highly toxic vapor is generated by acidification of sodium cyanide. Because residues of HCN may remain on fumigated citrus, a dietary risk assessment is required as part of the pesticide reregistration and tolerance reassessment process.

Dietary risk assessments are carried out on all food use pesticides, and ordinarily both acute and chronic dietary assessments are performed. In chronic pesticide dietary assessments, average dietary exposures are compared to chronic reference doses, whereas in acute dietary assessments, distributions of single day exposures computed from distributions of residue data and single day consumption data are compared to acute reference doses.

The HCN risk assessment team was faced with a shortage of toxicity data with which to carry out the required dietary assessments. Ordinarily, dietary risk assessments on pesticides are based on toxicity and residue data submitted by registrants, but there were no registrant submitted studies on cyanide compounds suitable for that purpose. There is a chronic Reference Dose ( RfD) for hydrogen cyanide in the Agency= s IRIS database ( http:// www. epa. gov/ iris/ subst/ 0060. htm). The chronic RfD is based on a two year feeding study in rats ( Howard and Hanzal, 1955) in which the rats were fed a diet that had been fumigated with HCN. The risk assessment team concluded that the RfD for HCN in IRIS was suitable for assessment of chronic dietary risks.

The HCN team did not identify any consensus reference values for assessment of acute toxicity. For many pesticides, suitable data for acute dietary assessment are lacking, and the decision is made to either not perform an acute assessment because the toxicity database suggests that acute toxicity is not an issue, or to use a repeated dose point of departure ( POD) since in the great majority of cases, PODs from repeated dose studies are lower than acute study PODs and therefore protective of acute toxicity.

It was clear to the HCN risk assessment team that acute toxicity of HCN is very much an issue, and that, because of the rapid metabolism of cyanide described below, chronic reference values reflecting day long dosing of small amounts of cyanide, are not necessarily protective of acute effects from administration of the same total amount of cyanide administered at one time. In the course of developing an assessment of acute dietary risks from use of HCN, the risk assessment team scoured the literature for appropriate oral toxicity data, considering not only animal toxicity studies on cyanide salts, but literature reports on human poisonings with cyanide salts, as well as studies on cyanogenic glycosides  natural compounds that release cyanide upon ingestion. The HCN team compared human data with animal data from similar types of toxicity studies, and has recommended a POD based one human study, but supported by a number of other studies. The studies considered in this analysis are presented in summary form and then the weight of evidence discussion of endpoint and POD selection follows. Page 3 of 8 Chemical Characterization. Hydrogen cyanide or hydrocyanic acid ( HCN) is a colorless, flammable liquid with an almond odor. The boiling point of HCN is 26.5 C and it has a very high vapor pressure, so it does not remain very long in the liquid state at atmospheric pressure. Hydrogen cyanide itself is not a registered pesticide in the U. S. It is generated at citrus fumigation sites in California from sodium cyanide and sulfuric acid.

Oral Toxicity. HCN is extremely acutely toxic by the oral route. Based on case history data, a fatal dose of HCN in humans is estimated to be 50 90 mg total or ~ 1 mg/ kg BW ( FDA, 1956). The lowest fatal dose of cyanide ( form not specified) reported in humans was estimated as 0.56 mg cyanide/ kg BW ( Gettler and Baine, 1938) in a person who died 3 hours after being found in a coma. The effects of acute cyanide exposure in humans are dominated by central nervous system and cardiovascular disturbances. Cyanide is a strong inhibitor of cytochrome oxidase, the terminal enzyme in the mitochondrial electron transport chain. Typical signs of acute cyanide poisoning include tachypnea, headache, vertigo, lack of motor coordination, weak pulse, cardiac arrhythmias, vomiting, stupor, convulsions, and coma.

In contrast to its high acute toxicity, hydrogen cyanide exhibits relatively low subchronic and chronic toxicity by the oral route. A 2 year rat feeding study with hydrogen cyanide fumigated food containing residues up to 300 ppm ( 10.8 mg/ kg/ day) showed no treatment related effects in clinical signs, body weight, food consumption, hematology, gross necropsy or histopathological changes in the organs examined. Rapid detoxification of hydrogen cyanide explains how the rats in the 2 year study could ingest 2 to 3 times the fatal acute dose each day throughout their lifetime without any measurable effects. Similarly, in a 13 week repeated dose toxicity study in which sodium cyanide was administered in the drinking water, there were no mortalities, clinical signs or histopathological effects in the brain, thyroid, or other organs of rats and mice exposed to doses up to 12.5 and 26 mg/ kg/ day respectively.

Metabolism. The unusual pattern of cyanide toxicity is explained by its rapid metabolism. Hydrogen cyanide is readily converted to thiocyanate in the liver by the enzyme rhodanese ( Cyanide: Thiosulfate Sulfur Transferase; E. C. <IP_ADDRESS>). This metabolic conversion, first demonstrated in 1894, is the major detoxification mechanism for hydrogen cyanide. Once thiocyanate is formed, it is not converted back to cyanide. Conversion of cyanide to thiocyanate is enhanced when cyanide poisoning is treated by intravenous administration of a sulfur donor ( e. g., sodium thiosulfate). The rapidity of this conversion was demonstrated in a case of humans where one twentieth the lethal dose ( 0.1 0.2 mg/ kg BW) of soluble cyanide was injected intravenously every ten minutes. In this case, more than the equivalent of an acutely fatal dose was reportedly administered without any apparent harm to the individual ( FDA, 1956). Based on the FDA study, as long as the oral intake of HCN does not exceed the body= s detoxification mechanisms via the formation of thiocyanate, HCN can be ingested in the form of dietary residues for prolonged periods without harm. Page 4 of 8 Toxicity Studies Considered for Acute Oral Risk Assessment Animal toxicity studies The critical study ( Howard and Hanzal, 1955) in IRIS that serves as the basis for the chronic RfD is described as follows:

In this 2 year dietary study, rats ( 10/ sex/ group) were administered food fumigated with hydrogen cyanide ( HCN). The average daily concentrations were 73 and 183 mg CN/ kg diet. From the data reported on food consumption and body weight, daily estimated doses were 4.3 mg and 10.8 mg CN/ kg bw. The average food CN concentrations were estimated based on the authors' data for concentrations at the beginning and end of each food preparation period and by assuming a first order rate of loss for the intervening period. There were no treatment related effects on growth rate, no gross signs of toxicity, and no histopathologic lesions ... the confidence in the study is medium because adequate records of food consumption and body weight were maintained, and animals of both sexes were tested at two doses for 2 years ( http:// www. epa. gov/ iris/ subst/ 0060. htm).

The NOAEL in the Howard and Hanzal study is considered to be the highest dose, 10.8 mg/ kg/ day. In addition to this study, the following information is available on the oral toxicity of cyanide in laboratory animals:

$ The ATSDR Tox Profile for cyanide ( ATSDR, 2004 ), mentions a number of acute lethality studies for cyanide salts. The acute oral LD50 in the rats, mice or rabbits from administration of sodium or potassium cyanide varied from 2 to 8 mg of CN/ kg.

$ The World Health Organization= s CICAD document for hydrogen cyanide ( WHO, 2004) discusses a 90 day study in the rat ( Hayes, 1967) with potassium cyanide in which no mortality was seen at a dietary dose of 250 mg/ kg/ day ( 100 mg CN/ kg), even though the LD50 for KCN in the rat is 10 mg/ kg ( 4 mg CN/ kg) when it is administered by gavage.

Human studies In a clinical trial of amygdalin ( Laetrile, D mandelonitrile   D glucosido 6 D glucoside), one hundred seventy eight cancer patients were treated with amygdalin plus a Ametabolic therapy@ consisting of diet, enzymes and vitamins. Amygdalin was administered at an intravenous dose of 4.5 g/ m2 of body surface area/ day ( standard dose) or 7 g/ m2 of body surface area/ day ( high dose) for 21 days. Following intravenous treatment, amygdalin was administered orally at 0.5 g three times daily at the standard dose regimen or 0.5 g four times daily at the high dose regimen until the patient had definite evidence of progressive malignant disease or until severe clinical deterioration occurred. Amygdalin releases HCN upon enzymatic action of   glucosidase in the GI tract causing high blood cyanide level and produces clinical toxicity. Clinical signs and symptoms consisting of nausea ( 30 31%), vomiting ( 17 25%), headaches ( 7 8%), dizziness ( 7 Page 5 of 8 10%), mental obtundation ( 4 5%) and dermatitis ( 2%) were observed on occasion following a single 0.5 g oral dose of amygdalin. Most of these typical symptoms of cyanide toxicity associated with elevated blood cyanide levels ( in the range of 2  3 µ g/ ml) were also seen when two 0.5 g oral doses were taken at the same time, or shortly apart, to compensate for a missed dose or when raw almonds ( a rich source of   glucosidase) were consumed following oral therapy. Therefore, the single dose of 0.5 g of amygdalin was determined to be a minimally toxic dose, whereas the double dose was generally regarded as frankly toxic. ( Moertel et al., 1982).

The cyanide risk assessment team is also aware of another human study described in a Quarterly Report of the Association of Food and Drug Officials by A. J. Lehman ( FDA, 1956). In this report total oral doses of 20 to 30 mg sodium cyanide ( the equivalent of 11.0 to 16.5 mg HCN or 0.2 mg HCN/ kg BW) were administered to an unknown number of individuals to demonstrate thiocyanate in saliva without apparent adverse effect. The risk assessment team was unable to obtain additional details of the study, and therefore neither the scientific validity nor the ethics of the study can be evaluated.

Weight of Evidence Discussion.

The goal of the HCN risk assessment team was to be able to assess the dietary risk of eating one or two hydrogen cyanide treated oranges in one sitting. The pesticide tolerance associated with the post harvest use of sodium cyanide on citrus is 50 ppm ( 50 mg of HCN per kg of citrus). If a 70 kg person were to eat one average orange ( including peel) weighing 160 g and containing HCN at the 50 ppm tolerance level, the corresponding dose would be approximately 0.1 mg/ kg which is 1/ 10 of a fatal dose in humans. The risk assessment team faced two tasks, how much HCN is actually available for ingestion on a treated orange, and what toxicity reference value is appropriate to compare with the estimated exposure?

With respect to an appropriate acute reference value, it was clear to the risk assessment team that the IRIS RfD for HCN was not useful for assessing acute risks. The POD on which the chronic RfD is based is a NOAEL in the rat of 10 mg CN/ kg/ day that reflects consumption over an entire day of HCN fumigated diet; whereas the acute lethality studies in animals mentioned in the ATSDR ( 2004) Draft Tox Profile for cyanide give a range of LD50s for sodium and potassium cyanide salts from 2  8 mg CN/ kg. It is apparent from a comparison of the acute LD50 studies and the chronic study NOAEL of 10 mg/ kg/ day that cyanide is much more hazardous when administered all at once rather than throughout the day.

In addition, in comparing the animal LD50s of 2 8 mg CN/ kg with fatal human doses of ~ 1 mg/ kg, there is a suggestion that humans may be more sensitive than animals on a mg/ kg basis. The Cyanide CICAD ( WHO, 2004) suggests that humans may be less able than rodents to detoxify cyanide because of a lower concentration of sulfur donors in humans. Page 6 of 8 The HCN team was not able to identify any studies in laboratory animals suitable for assessment of acute dietary risks, but they did identify the potentially useful clinical trial on the cyanogenic glycoside, amygdalin. In the clinical study, the oral dose of amygdalin was 0.5 g ( 500 mg) administered three times per day. The molecular weight of amygdalin is 457 and each molecule of amygdalin contains one equivalent of HCN ( molecular weight = 27). Therefore 500 mg of amygdalin has the potential to release 30 mg of HCN or 0.4 mg/ kg for a 70 kg person. There are some problems with using the clinical study of amygdalin for establishing an acute RfD for hydrogen cyanide. The subjects in the study were suffering from terminal cancer and it is not clear from the study to what extent the symptoms of toxicity observed were attributable to amygdalin administration or to the progression of cancer. Oral administration of amygdalin did not commence until each treated patient had received an i. v. treatment of amygdalin for 21 days, which confounds the interpretation of symptoms. In the main study, the listed toxic reactions did not seem to differ between the intravenous route and the oral route, despite the fact that only oral administration of amygdalin resulted in appreciable levels of blood cyanide.

The differences in blood cyanide concentrations between routes of exposure was explained on the basis that conversion of amygdalin to cyanide is dependent on enzymes ( s) in the gut or present in foods such as almonds. Intravenous amygdalin is not exposed to   glucosidase in the liver or bloodstream and so is excreted essentially unchanged, whereas oral amygdalin is converted to HCN. There is information of an anecdotal nature in the study that consumption of almonds with oral amygdalin enhances toxicity, highlighting another uncertainty about the study  the extent and rapidity of amygdalin conversion to cyanide. Other anecdotal information from the study indicates that doubling up of the 500 mg dose clearly results in more severe symptoms. Taken together, the data indicate that 500 mg amygdalin is more appropriately considered a minimal effect level with respect to cyanide toxicity. Overall attributing those symptoms to amygdalin is likely to be conservative Conclusion.

Despite the limitations of the clinical study on amygdalin, OPP= s HCN risk assessment team concluded that oral administration of 500 mg of amygdalin, equivalent to 30 mg of HCN or approximately 0.4 mg/ kg HCN, provided a reasonable basis to assess acute dietary risks from ingestion of citrus containing residues of HCN. The potential POD of 0.4 mg/ kg compares to the reported fatal dose in humans of approximately 1 mg/ kg ( FDA, 1956), the lowest known fatal dose in humans of 0.56 mg/ kg ( Gettler and Baine, 1938) and the unsubstantiated NOAEL for CN in humans of 0.2 mg/ kg ( FDA, 1956).

The team recommended using the equivalent NOAEL of 0.4 mg HCN/ kg with uncertainty factors of 10 x for intraspecies variation and a second factor of 10 x to account for a combination of severity of effect, steepness of dose response, as well as the indications from the clinical trial that 500 mg amygdalin per administration was a minimal effect level and not a NOAEL. The acute RfD is therefore 0.42 mg/ kg ) 100 = 0.004 mg/ kg. The factor is 1/ 5 that of the chronic RfD in IRIS based on chronic dietary administration of HCN treated food to rats. It is unusual that the Page 7 of 8 chronic RfD is exceeds the acute RfD; however, HED scientists believe that use of the acute RfD is appropriate whenever cyanide exposure is expected to occur all at once. Page 8 of 8 Bibliography Agency for Toxic Substances and Disease Registry ( ATSDR). 2004. Toxicological Profile for cyanide. ( Draft for Public Comment). Atlanta, GA: U. S. Department of Health and Human Services, Public Health Service.

Food and Drug Administration ( FDA, 1956), Association of Food and Drug Officials: Quarterly Report to the Editor on Topics of Current Interest: Hydrogen Cyanide and Amygdalin; A. J. Lehman, Ph. D., M. D., Editor Howard, J. W. and R. F. Hanzal. ( 1955). Chronic toxicity to rats of food treated with hydrogen cyanide. J. Agric. Food Chem. 3: 325 329.

Moertel, CG et al ( 1982). A Clinical Trial of Amygdalin ( Laetrile) in the Treatment of Human Cancer. New England Journal of Medicine, Vol. 306, No. 4: 201 206, MRID # 46769602, published.

Moertel, CG et al ( 1981) A Pharmacologic and Toxicological Study of Amygdalin. JAMA, Vol. 245, No. 6: 591 594, MRID # 46769601, published.

World Health Organization ( WHO, 2004), Hydrogen Cyanide and Cyanides: Human Health Aspects ( CICADS 61, 2004), Geneva


[Federal Register Volume 75, Number 249 (Wednesday, December 29, 2010)]
[Notices]
[Pages 82030-82031]
[FR Doc No: 2010-32739]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0640]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Data to Support Food and Nutrition Product
Communications, as Used by the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a generic clearance to collect information
to support communications about nutrition and food products regulated
by FDA. This data collection will gauge, informally, public opinion on
a variety of subjects related to consumer, patient, or health care
professional perceptions and use of nutrition and food products and
related materials, including but not limited to, food advertising, food
and nutrition labeling, emerging risk communications, online sales of
food products, and consumer and professional education.

DATES: Submit either electronic or written comments on the collection
of information by February 28, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Data to Support Food and Nutrition Product Communications, as Used by
the Food and Drug Administration--21 U.S.C. 393(d)(2)(D) (OMB Control
Number 0910-NEW)

    FDA plans to use the data collected under this generic clearance to
inform its nutrition and foods communications campaigns. FDA expects
the data to guide the formulation of its food and nutrition
communication objectives. FDA also plans to use the data to help tailor
print, broadcast, and use electronic media communications in order for
them to have powerful and desired impacts on target audiences. The data
will not be used for the purposes of making policy or regulatory
decisions.
    The information collected will serve two major purposes. First, as
formative research, it will provide the critical knowledge needed about
target audiences. FDA must explore audiences' beliefs, perceptions, and
decisionmaking processes about nutrition and food consumption in order
to formulate the basic objectives of its risk communication campaigns.
Such knowledge will provide the needed target audience understanding to
design effective communication strategies, messages, and product
labels. These communications will aim to improve public understanding
of the risks and benefits of consuming certain foods or nutritional
products by providing users with a better context in which to place
risk information more completely.
    Second, as initial testing, it will give FDA some information about
the potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. Testing
messages with a sample of the target audience will allow FDA to refine
messages while still in the developmental stage. Respondents may be
asked to give their reaction to the messages in individual or group
settings.
    FDA's Center of Food Safety and Applied Nutrition, Office of the
Commissioner, and other Centers or Offices will use this mechanism to
test messages about regulated food and nutrition products on a variety
of subjects related to consumer, patient, or health care professional
perceptions and use of foods and related materials, including but not
limited to, food advertising, food and nutrition labeling, emerging
risk communications, online sales of food products, and consumer and
professional education. The data will not be used for the purposes of
making policy or regulatory decisions.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                             Annual
                                            Number of     frequency per   Total annual      Hours per     Total
                                           respondents      response        responses       response      hours
----------------------------------------------------------------------------------------------------------------
Individual indepth interviews..........             360               1             360            0.75      270
General public focus group interviews..             144               1             144             1.5      216
Intercept interviews: central location.             600               1             600            0.25      150
Intercept interviews: telephone........      10,000 \2\               1          10,000            0.08      800
Self-administered surveys..............           2,400               1           2,400            0.25      600
Gatekeeper reviews.....................             400               1             400            0.50      200
Omnibus surveys........................           2,400               1           2,400            0.17      408
                                        ------------------------------------------------------------------------
    Total (general public).............          16,304  ..............          16,304  ..............    2,644
                                        ------------------------------------------------------------------------
    Total physician focus group                     144               1             144             1.5      216
     interviews........................
                                        ------------------------------------------------------------------------
    Total (overall)....................  ..............  ..............  ..............  ..............    2,860
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Brief interviews with callers to test messages, concepts and strategies following their call-in request to
  an FDA Center 1-800 number.

    Annually, FDA projects about 30 communication studies using the
variety of test methods listed in table 1. FDA is requesting this
burden so as not to restrict the Agency's ability to gather information
on public sentiment for its proposals in its regulatory and
communications programs.

    Dated: December 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32739 Filed 12-28-10; 8:45 am]
BILLING CODE 4160-01-P