[Federal Register: September 17, 2008 (Volume 73, Number 181)]
[Notices]
[Page 53889]
[DOCID:fr17se08-108]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-3290-EM]

Texas; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Texas (FEMA-3290-EM), dated August 29, 2008,
and related determinations.

DATES: Effective Date: August 29, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 29, 2008, the President declared an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of Texas resulting from Hurricane Gustav beginning on
August 27, 2008, and continuing, are of sufficient severity and
magnitude to warrant an emergency declaration under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121-5207 (the Stafford Act). Therefore, I declare that such an
emergency exists in the State of Texas.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), including direct Federal assistance, under the Public
Assistance program. This assistance excludes regular time costs for
subgrantees' regular employees. In addition, you are authorized to
provide such other forms of assistance under Title V of the Stafford
Act as you may deem appropriate.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. 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 emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Sandy
Coachman, of FEMA, is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of Texas have been designated as
adversely affected by this declared emergency:

    Angelina, Aransas, Austin, Bee, Bexar, Bowie, Brazoria, Brazos,
Brooks, Calhoun, Cameron, Chambers, Collin, Colorado, Dallas,
Denton, DeWitt, El Paso, Fort Bend, Galveston, Goliad, Hardin,
Harris, Hidalgo, Jackson, Jasper, Jefferson, Jim Hogg, Jim Wells,
Kenedy, Kleberg, Lavaca, Liberty, Lubbock, Matagorda, Montgomery,
Nacogdoches, Navarro, Newton, Nueces, Orange, Polk, Potter, Refugio,
Sabine, San Jacinto, San Patricio, Shelby, Smith, Starr, Tarrant,
Tom Green, Travis, Trinity, Tyler, Victoria, Waller, Walker, Webb,
Wharton, and Willacy 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.)

R. David Paulison,
Administrator,Federal Emergency Management Agency.
[FR Doc. E8-21673 Filed 9-16-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register: June 28, 2011 (Volume 76, Number 124)]
[Notices]
[Page 37872-37873]
[DOCID:fr28jn11-119]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64724; File No. SR-NASDAQ-2011-085]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Adopt a Market Order Timer

 June 22, 2011.
    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 June 20, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or
``NASDAQ'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III 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

    NASDAQ is filing with the Commission a proposal for the NASDAQ
Options Market (``NOM'') to amend Chapter VI, Trading Systems, Section
1, Definitions, to provide that Participants can designate that their
market orders not executed after a pre-established period of time be
cancelled back to the Participant, as described below. This optional
feature will be called the Market Order Timer.
    This change is scheduled to be implemented on NOM on or about
August 1, 2011; the Exchange will announce the implementation schedule
by Options Trader Alert, once the rollout schedule is finalized.
    The text of the proposed rule change is available at http://
nasdaq.cchwallstreet.com/, at NASDAQ's principal office, 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 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 purpose of the proposed rule change is to reflect in NOM's
rules new functionality respecting market orders. The Market Order
Timer is intended to provide an optional protection to all Participants
who enter market orders. This protection should help Participants
better manage both their risk and their order flow by controlling how
long a market order remains in the market.
    Currently, Chapter VI, Section 1(e)(5) defines market orders as
orders to buy or sell at the best price available at the time of
execution. The Exchange proposes to add an additional sentence to this
Section to reflect new functionality, which is that Participants can
designate that their market orders not executed after a pre-established
period of time will be cancelled back to the Participant. The pre-
established period of time, and any changes thereto, will be published
in a NOM notification to Participants, with sufficient advanced notice.
The pre-established period of time will be the same for all options.
The Exchange believes that this functionality should be beneficial to
Participants who choose to employ it, because it should serve as an
additional feature for Participants to manage their market orders on
NOM.
    Pursuant to Chapter VI, Sections 1 and 6 of NOM's rules, various
time-in-force (``TIF'') designations are available on NOM, including
Immediate or Cancel (``IOC''), Good-till-Cancelled (``GTC''), Day
(``DAY''), WAIT or Expire Time (``EXPR'').\3\ Currently, market orders
on NOM are treated as IOC, but the Exchange will soon accept, pursuant
to its existing rules, market orders with a time-in-force of DAY and
GTC \4\ at the same time that the Market Order Timer is implemented.
Accordingly, the Market Order Timer should be particularly useful for
NOM Participants

to manage market orders with TIFs other than IOC.
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    \3\ EXPR was eliminated in SR-NASDAQ-2011-052. See Securities
Exchange Act Release No. 64311 (April 20, 2011), 76 FR 23349 (April
26, 2011). This is scheduled to take effect in August 2011.
    \4\ See Chapter VI, Section 6(a)(1). Because Market Orders will
no longer be limited to IOC, the System will employ the normal book
order processing that applies to limit orders today for Market
Orders. See Chapter VI, Section 6, Acceptance of Quotes and Orders,
Section 7, Entry and Display Orders, Section 10, Book Processing and
Section 11, Order Routing.
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    Some Participants would prefer to have market orders cancelled if
they are not executed within a short timeframe, even if the order is
marked with a TIF of DAY or GTC. Other participants prefer to leave the
market order with an exchange even if it is not executed right away.
The Exchange believes that both the Market Order Timer and the
additional TIFs should be useful additional features for NOM
Participants. A common use of DAY and GTC market orders is when a
customer is trying to sell an option that no longer holds any value.
The customer enters a market order to sell that the customer expects
the exchange to retain on its book in the event that another
participant is willing to buy the option at $0.01 or $0.05. In this
case, the market order cannot be executed, because there is no interest
on the other side; thus, the Market Order Timer can be helpful when
there is no contra-side interest, and, conversely, it is not needed
when a marketable order executes right away. Accordingly, customers
should benefit from the additional TIFs for market orders as well as
from being able to choose whether a Market Order Timer applies.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \5\ in general, and furthers the objectives of Section
6(b)(5) of the Act \6\ 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 facilitating transactions in securities, and to
remove impediments to and perfect the mechanisms of a free and open
market and a national market system, and, in general, to protect
investors and the public interest. The Exchange believes that the
proposal should help market participants better manage their market
orders by providing a timer mechanism, which should, in turn, protect
investors and the public interest and promote just and equitable
principles of trade. The ability to, in effect, have market orders
automatically cancel after a pre-established time period helps market
participants manage the potential risks of using market orders.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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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.

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

    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 after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \7\ and Rule 19b-4(f)(6) \8\
thereunder.
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 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 the 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-085 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-NASDAQ-2011-085.
This file number should be included on the subject line if e-mail 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 a.m. and 3 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-NASDAQ-2011-085 and
should be submitted on or before July 19, 2011.
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    \9\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-16085 Filed 6-27-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Notices]
[Page 42955]
[DOCID:fr25au09-125]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

SMS Rail Service (Waiver Petition Docket Number FRA-2009-0068)

    The SMS Rail Service (SLRS) seeks a waiver from compliance of
certain provisions of the Federal hours of service law (49 U.S.C.
Chapter 211; HSL). Specifically, SLRS requests relief from 49 U.S.C.
Sec.  21103(a)(4) which states that a train employee may not be
required or allowed to remain or go on duty after that employee has
initiated an on-duty period each day for 6 consecutive days, unless
that employee has had at least 48 hours off duty at the employee's home
terminal.
    SLRS is not unionized and is not subject to any collective
bargaining agreements. In current operations, SLRS train employees
voluntarily work 6 days per week. Under the provisions of U.S.C. Sec.
21103(a)(4), these employees would be prohibited from returning to duty
without 48 hours off duty following the volunteer day. The entire SLRS
petition may be viewed at http://www.regulations.gov under the docket
number listed above.
    The HSL, at 49 U.S.C. 21108(a), contemplates that any request for a
waiver from its requirements will be a joint waiver involving the
relevant railroad carrier(s) and nonprofit employee labor
organization(s) representing the class or craft of directly affected
covered service employees. Because SLRS's covered service employees are
not represented by any employee labor organization, SLRS's waiver
request is made solely by the carrier. FRA recognizes that the intent
of 49 U.S.C. 21108(a) is to ensure that covered service employees are
provided meaningful input into any potential waiver of the HSL that
would affect their work schedules. Accordingly, before considering the
requested relief, FRA is requiring that within 30 days of the
publication date of this notice, SLRS submit evidence to the docket
demonstrating that it has sought employee input into the waiver
request, what that employee input was, and that it has provided each
covered employee affected by the request with a copy of the waiver
petition, along with information on how to submit comments to FRA on
the request. FRA will consider this additional information, along with
all other relevant factors, in determining whether granting the
requested relief would be in the public interest and consistent with
railroad safety.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0068) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC on August 18, 2009.
John Leeds,
Director, Office of Safety Analysis.
[FR Doc. E9-20428 Filed 8-24-09; 8:45 am]

BILLING CODE 4910-06-P


83 I IMPORTANT NOTE TO USER:

This OMB form has been recreated in WP6.0 by OPPTS staff. The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font ( Times New Roman 8pt).

 Do not change table lines ( although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5.1, so the text will scramble.

If you have any problems or questions, please call your RID Desk Officer @ 260 2706.

ADDITIONAL INFORMATION FOR OC STAFF:

The 83  I is signed by the Division Director in the box labeled " program official" These are the usual answers for OC's ICRs. They have already been marked on the form.

Block 3 c Block 4 a Block 6 a Block 11 b Block 12 c Block 15 g Block 17 no BLOCK 13  Numbers are drawn directly from your tables and supporting statement.

Example: 10 existing sources, 3 new a year ( 9 new over the life of the ICR), semiannual reports 13. Annual reporting and recordkeeping hour burden a. Number of respondents 13 ( 3 new + 10 existing)

b. Total annual responses 38 ( 3 new X 6 # of initial reports ( this example assumes 6. Count them for your particular ICR)) + ( 10 existing x 2 for semiannual reports)

1. Percentage of these responses collected electronically % c. Total annual hours requested Total hours from industry burden table d. Current OMB inventory Total requested & approved from previously approved ICR e. Difference d minus c ( can be + or ) This is a number f. Explanation of difference 1. Program Change Do not use this line unless there has been a change to the recordkeeping and/ or reporting in the regulation!

2. Adjustment # in e BLOCK 14  This is a relatively new one Does this standard require continuous monitoring? If no then zero out block 14 and explain in burden section of the supporting statement. This is probably only the case in a few old NSPS regulations and in LDAR regulations. If yes then what type of monitoring? PM, VOC and what is the cost of the monitoring device alone, not the control equipment! How much is yearly maintenance on the monitor?

14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 3 ( 3 new per year X $ 1,000 ( example # only)

initial capital cost per monitor) Remember it is in thousands b. Total annual costs ( O& M) 5 ( 10 existing X $ 500 ( example # only) operation &

maintenance cost per monitor) Remember it is in thousands c. Total annualized cost requested 8 ( a + b) Remember it is in thousands d. Current OMB inventory From previously approved ICR. If the OMB cover form had no block 14 use 0.

e. Difference d minus c ( can be + or )

f. Explanation of difference 1. Program change Do not use this line unless there has been a change to the monitoring device in the regulation!

2. Adjustment # in e Please remove the preceding instruction pages before finalizing! PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. EPA, Chemical, Commercial Services and Municipal Div 2. OMB control number b. G None a_ 2060 0097 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NESHAP Part 61 Subpart E; National Emission Standard for Mercury 8. Agency form number( s) ( If applicable) 0113.07 9. Keywords NESHAP, mercury, sewage sludge incineration, hazardous air pollutants, chlor alkali plants 10. Abstract To reduce public exposure to harmful effects of mercury vapors, owners/ operators of mercury ore processing plants, mercury cell chlor alkali plants and sewage sludge incinerators or dryers must meet national emission limits for mercury. Adequate recordkeeping and reporting enables EPA to verify continuous compliance with the standard.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 142 b. Total annual responses 24 1. Percentage of these responses collected electronically % c. Total annual hours requested 26,504 d. Current OMB inventory 37,066 e. Difference ( 10,562) f. Explanation of difference 1. Program Change 2. Adjustment ( 10,562) 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 2. Adjustment No continuous emissions monitoring in the rule.

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. _ P_ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. Q Annually 7. Q Biannually 8. Q Other ( describe) 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Melissa Raack Phone: 202 564 7039 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Elliott Gilberg Director, Chemical, Commercial Services and Municipal Division Date Signature of Senior Official or designee Joseph Retzer, Director Regulatory Information Division Office of Regulatory Management and Information ( OP) Date OMB 83 I 10/ 95


TOTAL COLIFORMS AND E. COLI MEMBRANE FILTRATION METHOD JUNE 2003 DRAFT Draft 1 June 2003 TOTAL COLIFORMS AND E. COLI MEMBRANE FILTRATION METHOD Sensitivity: 1 CFU/ 100 mL m ColiBlue24 ® Broth U. S. Environmental Protection Agency ( USEPA) Approved for Drinking Water Method No. 10029 Revision 3, 2/ 13/ 02 1.0 Scope and Application 1.1 This method determines the presence or absence of total coliforms and E. coli in finished potable water using a selective and differential membrane filtration ( MF) medium, m ColiBlue24 Broth.

1.2 This method can detect the presence or absence of both total coliforms and E. coli simultaneously within 24 hours and without the need for a confirmation step.

1.3 The detection limit of the method is one colony forming unit ( CFU) of coliform bacteria per 100 mL of sample. See Attachment 1.3.

2.0 Summary of Method 2.1 Coliform bacteria are identified in water either as total coliforms or E. coli. Total coliforms can be present in water without E. coli being present; E. coli cannot be present in water without total coliforms also being present.

2.2 A 100 mL volume of sample is filtered through a 47 mm membrane filter using standard techniques. The filter is then transferred to a 50 mm petri plate containing an absorbent pad saturated with m ColiBlue24 Broth. The filter is then incubated at 35 ° C ± 0.5 ° C for 24 hours. If coliform bacteria are present in the sample, both red and blue colonies may appear; the blue colonies are specific to the presence of E. coli.

2.3 m ColiBlue24 Broth is a nutritive, lactose based medium, containing inhibitors to selectively eliminate growth of non coliforms. It is analogous to an improved version of m Endo. Total coliform colonies growing on the medium are highlighted by a non selective dye, 2,3,5 Triphenoltetrazolium Chloride ( TTC), which produces red colored colonies. Among the total coliform colonies, which grow up on the medium, any E. coli colonies are distinguishable by a selective blue color, resulting from the action of b glucuronidase enzyme on 5 Bromo 4 Chloro 3 Indolyl Beta D glucuronide ( BCIG).

3.0 Definitions 3.1 Material Safety Data Sheet ( MSDS)  Written information provided for each chemical reagent or standard about a chemical's toxicity, health hazards, physical properties, flammability, and reactivity. It also includes storage, spill, and handling precautions. Draft 2 June 2003 3.2 Total Coliform Bacteria  Bacteria belonging to the genera Klebsiella sp., Enterobacter sp., Citrobacter sp., or Escherichia sp.

3.3 Coliform Positive Colony  A red or blue colony.

3.4 Coliform Negative Colony  A clear or white colony.

3.5 Escherichia coli or E. coli Bacteria  A genus within the total coliform group typified by possession of the enzyme b Glucuronidase, ability to grow at 44.5 ° C, and form indole from tryptophan.

3.6 E. coli Positive Colony  A blue colony.

3.7 E. coli Negative Colony  A non blue colony.

4.0 Interferences 4.1 No interferences to the colony color development have been found in finished potable water samples. Similarly, particulates in water samples do not alter the efficacy of the medium, although excess particulates may cause colonies to grow together on crowded filters or slow the sample filtration process.

5.0 Safety 5.1 Standard safety practices appropriate to microbiology laboratories should be followed. Follow the test procedure carefully and observe all precautionary measures.

5.2 Solid and liquid waste materials containing or suspected to contain viable bacteria should be decontaminated using an autoclave or by using an appropriate disinfectant before discarding.

5.3 Refer to the appropriate Material Safety Data Sheets supplied for each reagent for comprehensive safety data essential to proper use.

6.0 Equipment and Supplies 6.1 Equipment 6.1.1 Air Incubator  Capable of operating at 35 ° C ± 0.5 ° C.

6.1.2 Vacuum pump.

6.1.3 Membrane filtration funnel unit and flask.

6.1.4 Dissecting microscope, capable of 10   15X magnification. The microscope should be equipped with a fluorescent illuminator. Draft 3 June 2003 6.2 Supplies/ Glassware  Cleanse all glassware thoroughly with a suitable detergent and hot water, rinse with hot water to remove traces of detergent residual, and rinse again with laboratory pure water. Sterilize all glassware by autoclaving 15 min. at 121 ° C or by heating in an oven for at least 1 hour at 170 ° C.

6.2.1 Presterilized 50 mm MF petri plates with pads.

6.2.2 45 mm presterilized membrane filters.

6.2.3 Sterile Forceps.

6.2.4 Sterile glass or plastic sample collection containers.

6.2.5 Sterile graduated cylinders.

6.2.6 Sterile pipets.

6.2.7 Sterile MF filtration unit.

6.2.8 Side arm flask.

6.2.9 Biohazard bag.

6.2.10150 mL of sterile rinse water.

7.0 Reagents and Standards 7.1 Growth Medium 7.1.1 The membrane filtration method for total coliforms and E. coli utilizes m ColiBlue24 Broth, Hach product 26084 20, 26084 42, or 26084 50. The broth is provided in ready to use 2 mL ampules or 100 mL glass bottles. Under proper storage conditions ( 2   8 ° C) the broth has a shelf life of one year. The broth contains a nutritive medium and colorimetric indicators.

7.2 Dechlorinating Reagent 7.2.1 Hach decholorinating reagent Powder Pillow ( 14363 69) contains sodium thiosulfate ( Na2S2O3 ) and sodium sulfate ( Na2SO4).

7.2.2 To make a 3% sodium thiosulfate ( Na2S2O3 ) solution, add 48.18 g of sodium thiosulfate pentahydrate to approximately 500 mL of deionized water, then dilute to 1 L with deionized water. * Whirl Pak ® is a registered trademark and patented product of Nasco; U. S. Patent 2,973,131.

Draft 4 June 2003 8.0 Sample Collection, Dechlorination, Preservation, Shipment and Storage 8.1 Water Sample Collection 8.1.1 Sample Collection Containers  Samples should be collected in sterile, clean glass or heat resistant bottles. Presterilized Whirl Pak ® 1 Bags may also be used.

8.1.2 Sampling Procedure  Potable water samples are taken by first flushing the tap 2   3 minutes to clear service line. Collect samples using aseptic techniques to avoid contamination. For other water samples, aseptically collect water representative of the source.

8.2 Dechlorination  Water containing chlorine or other halogens must be treated with sodium thiosulfate to allow accurate evaluation of microbial content. Add one decholorinating reagent Powder Pillow ( 14363 69) by aseptically cutting off the tip of an alcohol rinsed pillow and pouring the contents into 100 mL of chlorinated water sample. Alternatively, pipet 0.1 mL of a 3% sodium thiosulfate ( Na2S2O3) solution into 100 mL of a chlorinated water sample. Presterilized Whirl Pak ® Bags contain sufficient sodium thiosulfate powder to neutralize a 100 mL chlorinated water sample.

8.3 Preservation, Shipment, Storage  Samples should be tested as soon as possible. If analysis cannot be done within 1 hr of collection, potable water samples should be held on ice or at 2   8 ° C in a refrigerator for a maximum holding time of 30 hours ( 16.1). Non potable samples should be held at < 10 ° C for a maximum period of 8 hours from sampling to analysis.

9.0 Quality Control 9.1 m ColiBlue24 Broth undergoes quality control ( QC) testing at the time of manufacture. A Certificate of Analysis is included with every m ColiBlue24 product, stating that the m ColiBlue24 Broth, as received by the analyst, is ready for use in analyzing water samples by the membrane filtration procedure. Each laboratory should test quality control using the following procedure. Three ampules will be required, as well as membrane filtration equipment. The three ampules will be used as an uninoculated blank, a positive control for both total coliforms and E. coli, and a negative control.

9.2 The day before the QC procedure, inoculate three 10 mL Tryptic Soy Broth tubes with Psuedomonas aeruginosa ( ATCC 27853). Incubate at 35 ° C ± 0.5 ° C for 24 ± 4 hours.

9.3 Aseptically open three ampules of m ColiBlue24 Broth and saturate the pads in three MF petri dishes.

9.4 Filter 100 mL of sterile water and place filter on the first pad. This is the uninoculated blank. Draft 5 June 2003 9.5 Prepare serial dilutions as described in Standard Methods 9222B ( 16.2). Prepare a serial dilution of the 24 hr. P. aeruginosa culture so that filtration of a 100 mL volume would theoretically yield 20   80 colonies. Filter the bacteria containing diluent. After filtration, rinse the funnel with several 20   30 mL volumes of sterile rinse water. Place membrane filter into the second plate of m ColiBlue24 Broth; this is the negative control. Prepare appropriate serial dilutions of the E. coli culture and filter. Rinse the funnel as previously indicated. Using this same membrane filter, serially dilute the E. cloacae culture, filter and rinse. This will introduce both E. coli cells and E. cloacae cells onto the same filter for a dual positive control. Incubate all three MF petri plates for 24 hours at 35 ° C ± 0.5 ° C. The uninoculated control should remain blank. The P. aeruginosa control should have no colonies. The positive control should have both blue ( E. coli) and red ( E. cloacae) colonies.

9.6 Colonies may be picked from membrane filters and inoculated into Lauryl Tryptose Broth ( LTB), Brilliant Green Lactose Bile ( BGLB), EC+ MUG, or other media for further QC testing if desired.

10.0 Calibration and Standardization 10.1 No calibration or standardization of m ColiBlue24 Broth is required.

10.2 All equipment used in Section 6 should be calibrated and maintained according to manufacturer's instructions.

11.0 Procedure 11.1 Test Procedure 11.1.1 Aseptically open an ampule containing m ColiBlue24 Broth and pour the broth onto the pad in a 50 mm MF petri plate.

11.1.2 Place a sterile filter onto a sterile filter holder. Using sterile graduated cylinders and pipets, measure an appropriate sample aliquot. Pour water sample into reservoir funnel on filter holder and draw the water through the filter using a vacuum pump. Rinse the funnel with several 20   30 mL volumes of sterile rinse water. With sterile forceps, transfer the filter to a petri plate containing the pad saturated with m ColiBlue24. Invert plate and incubate at 35 ° C ± 0.5 ° C for 24 hours.

11.2 Interpretation 11.2.1 Examine filters for colony growth. Colonies are typically readily visible, but a dissecting microscope may prove useful. Draft 6 June 2003 11.2.2 A red or blue colony is a Total Coliform Positive result. A clear or white colony is a Total Coliform Negative result. A blue colony is specifically an E. coli Positive result. A non blue colony is an E. coli Negative result:

Positive Result Negative Result Total Coliform Red or Blue Colony Clear or White Colony E. coli Blue Colony only Non Blue Colony 11.2.3 The incubation time is 24 hours. If no colonies are visible after 24 hours, the sample is free of total coliforms and E. coli.

12.0 Data Analysis, Calculations, Interpretation and Reporting 12.1 Presence/ Absence 12.1.1 The presence of at least one red or blue colony indicates the sample is total coliform positive. The presence of at least one blue colony also indicates the sample contains E. coli. Absence of red or blue colonies indicates the sample contains no total coliforms or E. coli. No further analysis or calculation is required.

12.2 Quantitation 12.2.1 This method is approved by the USEPA for the purposes of determining the presence or absence of total coliforms and E. coli in drinking water. Since a protocol for evaluating the use of a new method for the enumeration of total coliforms and/ or E. coli in drinking water does not exist, new methods, such as m ColiBlue24, cannot be approved by the USEPA as quantitative methods for USEPA reporting purposes. However, we have included the enumeration protocol for other ( non USEPA reporting) purposes.

12.2.2 Coliform density determinations can often provide additional data for problem solving within the water plant or for analysis of source water samples. m Coliblue24 Broth can be used to make density determinations.

12.2.3 If enumeration of total coliform and/ or E. coli populations is desired, refer to Standard Methods 9222B for appropriate dilutions of the sample to filter so that 20   80 coliform colonies are present after incubation. For analysis of potable water samples, a standard sample of 100 mL is always required. Calculate the number of microorganisms per 100 mL sample also as described in Standard Methods 9222B. Draft 7 June 2003 13.0 Method Performance Characteristics 13.1 Specificity: The specificity of m ColiBlue24 Broth for recovery of total coliforms and E. coli was evaluated. These experiments were conducted according to the EPA protocol of June 30, 1992 ( 16.3). For E. coli, the false positive error was 2.5% and the undetected target error was 0% ( Section 17.0, Table 17.1). Overall agreement between m ColiBlue24 and E. coli reference methods was 98.8%. For total coliforms, the false positive error was 26.8% and the undetected target error was 1.6% ( Table 17.2). Using m Endo as a comparison for total coliform recovery to m ColiBlue24, m Endo total coliform false positive error was 29.6% and the undetected target error was 3.4 % ( Table 17.3). Overall agreement for total coliform recovery was 86.2% for m ColiBlue24, and 85.7% with m Endo. Although the total coliform false positive errors seemed large initially, review of the literature revealed that many existing media for total coliform recovery have similar false positive error rates ( 16.4  16.10).

13.2 Precision and Bias: Not applicable, as this protocol was conducted on a presence/ absence basis. If individuals wish to use this medium for quantitative determinations they may use precision and bias calculations specified by ASTM ( 16.11).

14.0 Pollution Prevention 14.1 Base the quantity of chemicals purchased on expected usage during its shelf life and disposal cost of unused material. Actual reagent preparation volume should reflect anticipated usage and reagent stability.

14.2 For information about pollution prevention that may be applicable to laboratories and research institutions, consult Less is better: Laboratory Chemical Management for Waste Reduction, available from the American Chemical Society's department of Government Regulations and Science Policy, 1155 16th Street N. W., Washington D. C., 20036. Phone: ( 202) 872 4477.

15.0 Waste Management 15.1 It is the laboratory's responsibility to comply with all federal, state, and local regulations governing waste management, particularly the hazardous waste identification rules and land disposal restrictions, and to protect the air, water, and land by minimizing and controlling all releases from fume hoods and bench operations. Compliance with all sewage discharge permits and regulations is also required.

15.2 See the MSDS for product composition information and further guidance on waste disposal.

15.3 For more information on laboratory waste management, consult Waste Management Manual for Laboratory Personnel, available from the American Chemical Society's department of Government Regulations and Science Policy, 1155 16th Street N. W., Washington D. C., 20036. Phone: ( 202) 872 4477. Draft 8 June 2003 16.0 References 16.1 Federal Register, Title 40, Part 141, Section 141.21 Coliform sampling. December 5, 1994.

16.2 " American Public Health Association, American Water Works Association, Water Environment Federation. Microbiological Examination, Part 9000" in: Standard Methods for the Examination of Water and Wastewater, 18th ed., A. E. Greenberg, L. S. Clesceri, A. D. Eaton, eds. Washington, D. C., American Public Health Association, 1993.

16.3 U. S. Environmental Protection Agency. Requirements for the nationwide approval of new or optionally revised methods for total coliforms, fecal coliforms, and/ or E. coli, in national drinking water monitoring. Revision 1.2, June 30, 1992. Environmental Monitoring Systems Laboratory, Cincinnati, OH.

16.4 Brenner, K. P., C. C. Rankin, Y. R. Roybal, G. N. Stelma, P. V. Scarpino, and A. P. Dufour. 1993. New medium for the simultaneous detection of total coliforms and Escherichia coli in water. Appl. Environ. Microbiol. 59: 3534   3544.

16.5 Cenci, G., A. De Bartolomeo, and G. Caldini. 1993. Comparison of fluorogenic and conventional membrane filter media for enumerating coliform bacteria. Microbios 76: 47   54.

16.6 Covert T. C., L. C. Shadix, E. W. Rice, J. R. Haines, and R. W. Freyberg. 1989. Evaluation of the autoanalysis colilert test for detection and enumeration of total coliforms. Appl. Environ. Microbiol. 55: 2443   2447.

16.7 Edberg, S. C., M. J. Allen, D. B. Smith, and the national collaborative study. 1988. National field evaluation of a defined substrate method for the simultaneous enumeration of total coliforms and Escherichia coli from drinking water: comparison with the standard multiple tube fermentation method. Appl. Environ. Microbiol. 54: 1595   1601.

16.8 Jacobs, N. J., W. L. Zeigler, F. C. Reed, T. A. Stukel, and E. W. Rice. 1986. Comparison of membrane filter, multiple fermentation tube, and presence absence techniques for detecting total coliforms in small community water systems. Appl. Environ. Microbiol. 51: 1007   1012. 16.9 Lupo, L., E. Stickland, A. Dufour, and V. Cabelli. 11977. The effect of oxidase positive bacteria on total coliform density estimates. Health Lab. Sci. 14: 117 121.

16.10 Sartory, D. P. and L. Howard. 11992. A medium detecting b glucuronidase for the simultaneous membrane filtration enumeration of Escherichia coli and coliforms from drinking water. Lett. Appl. Microbiol. 15: 273 276.

16.11 American Society for Testing and Materials. Determination of precision and bias applicable methods of committee D 19 on water. D 2777 86. Annual Book of ASTM Standards, Vol. 11.01. ASTM, Philadelphia, 1993. Draft 9 June 2003 17.0 Tables 17.1 E. coli recovery on m ColiBlue24 Reference Positive Negative Total Positive 234 6 240 Negative 0 250 250 Total 234 256 490 Sensitivity 100.0% Specificity 97.7% False Positive Error 2.5% Undetected Target Error 0% Overall Agreement 98.8%

17.2 Coliform recovery on m ColiBlue24 Reference Positive Negative Total Positive 183 67 250 Negative 2 248 250 Total 185 315 500 Sensitivity 96.8% Specificity 80.1% False Positive Error 29.0% Undetected Target Error 3.2% Overall Agreement 85.7%

Reference Positive Negative Total Positive 149 61 210 Negative 5 245 250 Total 154 306 460 Sensitivity 96.8% Specificity 80.1% False Positive Error 29.0% Undetected Target Error 3.2% Overall Agreement 85.7%


[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Notices]
[Pages 55702-55703]
[FR Doc No: 2023-17507]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1275]

Demonstrating Bioequivalence for Type A Medicated Articles
Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly
Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting; Draft Guidance for Industry;
Availability; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the notice of availability that
published in the Federal Register of June 8, 2023. In that notice, FDA
requested comments on the draft guidance for industry (GFI) #279
entitled ``Demonstrating Bioequivalence for Type A Medicated Articles
Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly
Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting.'' The Agency is taking this
action in response to a request for an extension to allow interested
persons additional time to develop and submit comments.

DATES: FDA is reopening the comment period on the notice of
availability published June 8, 2023 (88 FR 37551). Submit either
electronic or written comments on the draft guidance by October 16,
2023 to ensure that the Agency considers your comments on this draft
guidance before it begins work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-1275 for ``Demonstrating Bioequivalence for Type A Medicated
Articles Containing Active Pharmaceutical Ingredient(s) Considered To
Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the

Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ian Hendricks, Center for Veterinary
Medicine (HFV-172), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 8, 2023 (88
FR 37551), FDA published a notice announcing the availability of draft
GFI #279 entitled ``Demonstrating Bioequivalence for Type A Medicated
Articles Containing Active Pharmaceutical Ingredient(s) Considered To
Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting.'' Interested persons were
originally given until August 7, 2023, to comment on the draft
guidance.
    The Agency received a request for a 60-day extension of the comment
period for the draft guidance. The requestor indicated they needed more
time to complete development of comments to submit in response to the
draft guidance. FDA has considered the request and is reopening the
comment period for the draft guidance for 60 days, until October 16,
2023. The Agency believes that a 60-day reopening of the comment period
allows adequate time for interested persons to submit comments to
ensure that the Agency can consider the comments on this draft guidance
before it begins work on the final version of the guidance.

    Dated: August 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17507 Filed 8-15-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44802-44803]
[FR Doc No: 2017-20522]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0429]

Classification of Products as Drugs and Devices and Additional
Product Classification Issues; Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry and FDA staff
entitled ``Classification of Products as Drugs and Devices & Additional
Product Classification Issues.'' This guidance provides the Agency's
current thinking on approaches for classifying products as drugs and
devices, and on certain additional product classification issues.

DATES: The announcement of the guidance is published in the Federal
Register on September 26, 2017.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-D-0429 for ``Classification of Products as Drugs and Devices &
Additional Product Classification Issues.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff office between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance document
entitled ``Classification of Products as Drugs and Devices & Additional
Product Classification Issues'' to the Office of Combination Products,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm.
5129, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Associate Director
for Policy, Office of Combination Products, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Classification of Products as Drugs and Devices &
Additional Product Classification Issues.'' This guidance finalizes two
related draft guidance documents issued in June 2011, entitled
``Classification of Products as Drugs and Devices & Additional Product
Classification Issues'' and ``Interpretation of the Term 'Chemical
Action' in the Definition of Device under Section 201(h) of the Federal
Food, Drug, and Cosmetic Act.''
    This guidance is intended to provide the Agency's current thinking
on approaches for classifying products as drugs and devices, and on
certain additional product classification issues. FDA determines
whether to classify a product as a drug or device based on the
statutory definitions for these terms set forth in section 201(g) and
(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.S.C. 321(g) and (h)), respectively, as applied to the scientific data
concerning the products

that are available to FDA at the time the classification determination
is made.
    FDA regularly receives questions from medical product sponsors
concerning the classification of their products. We believe that
efficient, effective regulation would be facilitated by providing
guidance on this topic. This guidance discusses the request for
designation (RFD) process for obtaining a formal determination of a
product's classification, and provides general concepts regarding FDA's
decision process for making classification determinations. While issues
have arisen relating to whether a product should be classified as a
drug, device, biological product, or combination product, issues most
frequently arise regarding whether a product should be classified as
either a drug or a device. Accordingly, this guidance focuses
particularly on cases in which a product may be classified as a drug or
device.
    This guidance is organized into two substantive sections. Section
II provides information on the RFD process for obtaining a formal
determination of whether a product is classified as a drug or device
and on obtaining other feedback from FDA on product classification
questions. Section III discusses general concepts and definitions
relating to FDA's decisional process for making classification
determinations and addresses issues that may arise in determining
whether products should be classified as drugs or devices.
    FDA carefully considered the comments received on the two draft
guidances in preparing this final guidance. We have combined the two
documents into one and made other changes for clarity and ease of
reference. For example, we have revised the discussion of the Agency's
interpretation and application of the term ``chemical action'' in the
definition of device at section 201(h) of the FD&C Act, to more clearly
explain the Agency's approach. With regard to this issue and others, we
have also included additional examples to illustrate the application of
the Agency's current thinking.
    In light of comments received, we have also reconsidered inclusion
of content on the status of prior Agency classification determinations.
FDA has had limited experience with reevaluating classification
determinations as the issue rarely arises for FDA to consider. In
addition, it can raise a variety of complex scientific and regulatory
questions. Accordingly, we have concluded that it is not appropriate to
address the topic further in guidance at this time. We will continue to
address the issue on a case-by-case, fact-specific basis as needed, in
a transparent manner as permitted by, and consistent with, applicable
legal requirements. Any stakeholder who has questions regarding the
classification of a currently marketed product or whether that
classification should be relied upon with respect to a proposed product
is encouraged to contact the Office of Combination Products.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Classification of Products as Drugs and
Devices & Additional Product Classification Issues.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 3 have been approved under
OMB control number 0910-0523.

IV. Electronic Access

    Persons with access to the internet may obtain the document at
https://www.fda.gov/RegulatoryInformation/Guidances/ucm258946.htm.

    Dated: September 21, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20522 Filed 9-25-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45227-45228]
[FR Doc No: 2023-14922]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0008]

Request for Nominations From Industry Organizations Interested in
Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on Public Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
that any industry organizations interested in participating in the
selection of nonvoting industry representatives to serve on its public
advisory committees for the Center for Drug Evaluation and Research
(CDER) notify FDA in writing. FDA is also requesting nominations for
nonvoting industry representatives to serve on CDER's public advisory
committees. A nominee may either be self-nominated or nominated by an
organization to serve as a nonvoting industry representative.
Nominations will be accepted for current vacancies effective with this
notice.

DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by August 14,
2023, (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by August 14, 2023.

ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nominations should be sent to Nicholas Marsh
(see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting
industry representatives may be submitted electronically by accessing
the FDA Advisory Committee Membership Nomination Portal at: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail
to Division of Advisory Committee and Consultant Management, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2418,
Silver Spring, MD 20993-0002. Information about becoming a member of an
FDA advisory committee can also be obtained by visiting FDA's website
at: http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Nicholas Marsh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2418, Silver Spring, MD 20993-0002, 240-
402-5357, email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative to the following advisory committees:

I. CDER Advisory Committees

A. Anesthetic and Analgesic Drug Products Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in anesthesiology and surgery.

B. Antimicrobial Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of infectious diseases and disorders.

C. Arthritis Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of arthritis, rheumatism, and related diseases.

D. Cardiovascular and Renal Drugs Advisory Committee

    Reviews and evaluates available data on the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of cardiovascular and renal disorders.

E. Dermatologic and Ophthalmic Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of dermatologic and ophthalmic disorders.

F. Drug Safety and Risk Management Advisory Committee

    Reviews and evaluates information on risk management, risk
communication, and quantitative evaluation of spontaneous reports for
drugs for human use.

G. Endocrinologic and Metabolic Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of endocrine and metabolic disorders.

H. Gastrointestinal Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of gastrointestinal diseases.

I. Medical Imaging Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in diagnostic and therapeutic procedures using radioactive
pharmaceuticals and contrast media used in diagnostic radiology.

J. Nonprescription Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of over-the-counter (nonprescription) human drug products
for use in the treatment of a broad spectrum of human symptoms and
diseases.

K. Obstetrics, Reproductive and Urologic Drugs Advisory Committee
(Formerly Bone, Reproductive and Urologic Drugs Advisory Committee)

    Reviews and evaluates available data on the safety and
effectiveness of marketed and investigational human drugs for use in
the practice of obstetrics, gynecology, urology and related
specialties.

L. Oncologic Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of cancer.

M. Peripheral and Central Nervous System Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of neurologic diseases.

N. Pharmaceutical Science and Clinical Pharmacology Advisory Committee

    Reviews and evaluates scientific, clinical, and technical issues
related to the safety and effectiveness of drug products for use in the
treatment of a broad spectrum of human diseases.

O. Pharmacy Compounding Advisory Committee

    Provides advice on scientific, technical, and medical issues
concerning drug compounding.

P. Psychopharmacologic Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the practice of psychiatry and related fields.

Q. Pulmonary-Allergy Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of pulmonary disease and diseases with allergic
and/or immunologic mechanisms.

II. Selection Procedure

    Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations and a list of all nominees
along with their current r[eacute]sum[eacute]s. The letter will also
state that it is the responsibility of the interested organizations to
confer with one another and to select a candidate, within 60 days after
the receipt of the FDA letter, to serve as the nonvoting member to
represent industry interests for the committee. The interested
organizations are not bound by the list of nominees in selecting a
candidate. However, if no individual is selected within 60 days, the
Commissioner of Food and Drugs will select the nonvoting member to
represent industry interests.

III. Application Procedure

    Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA
Advisory Committee Membership Nomination Portal (see ADDRESSES) within
30 days of publication of this document (see DATES). FDA will forward
all nominations to the organizations expressing interest in
participating in the selection process for the committee. Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process.
    FDA seeks to include the views of women, and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: July 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14922 Filed 7-13-23; 8:45 am]
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[Federal Register: September 13, 2006 (Volume 71, Number 177)]
[Notices]
[Page 54055-54057]
[DOCID:fr13se06-85]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0687; FRL-8091-3]

Petition to Amend Certain FIFRA Section 25(b) Pesticide Products;
Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice identifies a petition filed by the Consumer
Specialty

Products Association (CSPA) pertaining to FIFRA section 25(b) pesticide
products. The petition requests the Agency to modify the minimum risk
regulations at 40 CFR 152.25(f) for those products that claim to
control public health pests (as defined in Pesticide Registration (PR)
Notice 2002-1) and requests that any such product making public health
claims be subject to EPA registration requirements as a precondition of
their sale. The Agency has determined that the petition may be of
regional and national significance.

DATES: Comments must be received on or before November 13, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0687, by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0687. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Brian Steinwand, Biopesticide and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you produce,
manufacture, distribute, sell or use exempted products that claim to
control public health pests. Potentially affected entities may include,
but are not limited to: Registered and unregistered establishments that
commercialize products that claim to control or mitigate any pests that
pose a threat to human health.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR 152.25(f). If
you have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date, and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What is the Basis of the Petition?

    The minimum risk pesticide exemption at 40 CFR 152.25(f) exempts

from the requirements of FIFRA those products whose only active
ingredients are among a set of ingredients listed in the exemption,
provided that, among other things:
    1. The only inert ingredients in the product are those listed in
the most current List 4A (minimal risk ingredients);
    2. The product does not ``bear claims either to control or mitigate
microorganisms that pose a threat to human health, including but not
limited to disease transmitting bacteria or viruses, or claims to
control insects or rodents carrying specific diseases, including, but
not limited to ticks that carry Lyme disease''; and
    3. The product does not ``include any false and misleading labeling
statements, including those listed in 40 CFR 156.10(a)(5)(i) through
(viii).''
    The petitioner argues that the exemption in 40 CFR 152.25(f) as
currently written, endangers public health by permitting labeling
claims for effectiveness against public health pests without requiring
proof that these exempt pesticides are effective against such pests.

III. What Action is the Agency Taking?

    Through this notice, the Agency is providing notice of the petition
submitted by CSPA and is asking for public comment. Following the
review of the petition and any comments received in response to this
notice, EPA will decide how best to respond to the petition. The
petition, as well as a summary prepared by the petitioner is available
on EPA's Electronic Docket at http://www.regulations.gov. To locate

this information on the homepage of EPA's Electronic Docket, select
``Quick Search'' and type the OPP docket ID number EPA-HQ-OPP-2006-
0687. Once the search has located the docket, clicking on ``Docket ID''
will bring up a list of all documents in the docket related to the
petition.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: September 1, 2006.
James Jones,
Director, Office of Pesticide Programs.
[FR Doc. E6-15204 Filed 9-12-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Proposed Rules]
[Pages 46426-46427]
[FR Doc No: 2017-21362]

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

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0523; Airspace Docket No. 17-ACE-9]

Proposed Amendment of Class E Airspace; Fort Scott, KS; and
Phillipsburg, KS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class E airspace extending
upward from 700 feet above the surface at Fort Scott Municipal Airport,
Fort Scott, KS, and Phillipsburg Municipal Airport, Phillipsburg, KS.
The FAA is proposing this action due to the decommissioning of the Fort
Scott non-directional beacon (NDB) and the Phillipsburg NDB and the
cancellation of the associated instrument approach procedures. This
action would enhance the safety and management of instrument flight
rules (IFR) operations at these airports.

DATES: Comments must be received on or before November 20, 2017.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2017-0523; Airspace Docket No. 17-ACE-9 at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend Class E airspace extending upward from 700 feet above
the surface at Fort Scott Municipal Airport, Fort Scott, KS, and
Phillipsburg Municipal Airport, Phillipsburg, KS, to support IFR
operations at these airports.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2017-0523/
Airspace Docket No. 17-ACE-9.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in

person in the Dockets Office (see the ADDRESSES section for the address
and phone number) between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays. An informal docket may also be
examined during normal business hours at the Federal Aviation
Administration, Air Traffic Organization, Central Service Center,
Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by:
    Modifying Class E airspace extending upward from 700 feet above the
surface to within a 6.4-mile radius (reduced from a 7-mile radius) of
Fort Scott Municipal Airport, Fort Scott, KS; removing the Fort Scott
NDB from the legal description; and removing the extension north of the
NDB; and
    Modifying Class E airspace extending upward from 700 feet above the
surface to within a 6.5-mile radius (reduced from a 7.6-mile radius) of
Phillipsburg Municipal Airport, Phillipsburg, KS; removing the
Phillipsburg NDB from the legal description; and removing the extension
southeast of the NDB.
    Airspace reconfiguration is necessary due to the decommissioning of
the Fort Scott NDB and the Phillipsburg NDB, the cancellation of the
associated instrument approach procedures, and to bring the airspace in
compliance with FAA Order 7400.2L, Procedures for Handling Airspace
Matters. Controlled airspace is necessary for the safety and management
of standard instrument approach procedures for IFR operations at these
airports.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11B, dated August 3, 2017, and effective September 15,
2017, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017, and
effective September 15, 2017, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE KS E5 Fort Scott, KS [Amended]

Fort Scott Municipal Airport, KS
    (Lat. 37[deg]47'54'' N., long. 94[deg]46'10'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Fort Scott Municipal Airport.
* * * * *

ACE KS E5 Phillipsburg, KS [Amended]

Phillipsburg Municipal Airport, KS
    (Lat. 39[deg]44'09'' N., long. 99[deg]19'02'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Phillipsburg Municipal Airport.

    Issued in Fort Worth, Texas, on September 27, 2017.
Wayne Eckenrode,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-21362 Filed 10-4-17; 8:45 am]
BILLING CODE 4910-13-P