[Federal Register: December 12, 2006 (Volume 71, Number 238)]
[Notices]
[Page 74501-74502]
[DOCID:fr12de06-58]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP01-377-012]

Northern Border Pipeline Company; Notice of Negotiated Rate

December 4, 2006.
    Take notice that on November 29, 2006, Northern Border Pipeline
Company (Northern Border) tendered for filing to become part of its
FERC Gas Tariff, First Revised Volume No. 1, Sixteenth Revised Sheet
No. 99, to become effective December 1, 2006:
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21056 Filed 12-11-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: February 12, 2007 (Volume 72, Number 28)]
[Notices]
[Page 6626-6628]
[DOCID:fr12fe07-123]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55233; File No. SR-BSE-2006-56]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing of Proposed Rule Change and Amendment No. 1 Thereto To
Add to the Boston Options Exchange a New Functionality Called an
Automatic Auction Order

February 2, 2007.
    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 December 15, 2006, the Boston Stock Exchange, Inc. (``BSE'' or
``Exchange'') 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 substantially prepared by the BSE.
On February 1, 2007, BSE filed Amendment No. 1 to the proposed rule
change.\3\ The Commission is publishing this notice to solicit comments
on the proposed rule change, as amended, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, BSE granted the Commission an extension
of the time period specified in Section 19(b)(2) of the Act for
Commission action.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Boston Options Exchange
(``BOX'') Rules to add a new functionality referred to as an Automatic
Auction Order (``AAO'') in order to make it easier for non-professional
customers to participate in a price improvement auction (``Improvement
Auction''). The text of the proposed rule change is available at BSE,
the Commission's Public Reference Room, and http://www.bostonstock.com/legal/pending_rule_filings.html
.

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 BSE 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 BSE 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
    BSE seeks to amend the BOX Rules \4\ to add a new order
functionality called an AAO in order to make it easier for all
Customers, including non-professional customers, to participate in
Improvement Auctions (e.g., the PIP). BOX believes that the AAOs will
increase the number of Improvement Orders that are submitted to an
Improvement Auction, thereby creating increased competition and overall
liquidity while also improving execution prices for trades that are
executed on BOX.
---------------------------------------------------------------------------

    \4\ Capitalized terms not otherwise defined herein shall have
the meanings prescribed under the BOX Rules.
---------------------------------------------------------------------------

    This AAO functionality automates a process that is currently
available to the non-professional customer via the Customer PIP Order
(``CPO''). Currently, however, it is difficult for non-professional
customers to participate in Improvement Auctions because of the limited
offering of the CPO by Order Flow Providers (``OFPs''). Only a few OFPs
have made CPOs available to non-professional customers due, in large
part, to the constraints that are generally

associated with the software development an OFP is required to
undertake in order to handle the processing of the CPO. The AAO
provides non-professional customers with the ability to trade on the
BOX Book at standard trading increments and also trade in penny
increments in an Improvement Auction, should one occur. The AAO, as
opposed to a standard Limit Order, allows a Customer to participate in
the Improvement Auction without any further instructions from the
Customer.
    The AAO allows for increased competition in the Improvement Auction
and offers greater opportunity for price improvement to occur by
providing for additional Improvement Orders capable of improving
prices.

Description of AAO Processing

    An AAO is a Limit Order that is submitted by the OFP on behalf of a
Customer to the BOX Trading Host in one-cent increments only on a class
whose minimum trading increment is greater than one cent. The penny
incremented limit price that is entered by the Customer is referred to
as the ``AAO Maximum Improvement Price.'' The AAO Maximum Improvement
Price is the maximum (if the order is to buy) or minimum (if the order
is to sell) price at which the Customer is willing to trade in any
Improvement Auctions.

AAO Limit Order

    The Trading Host will round AAOs to the nearest minimum trading
increment \5\ (up if the order is to sell and down if the order is to
buy) and place it on the BOX Book (``AAO Limit Order''). The AAO Limit
Order will be processed as a standard Limit Order as described in
Chapter 5, Section 14(c)(i) of the BOX Rules and will be traded in
accordance with Chapter 5, Section 16 of the BOX Rules.
---------------------------------------------------------------------------

    \5\ As delineated in Chapter V, Section 6 of the BOX Rules.
---------------------------------------------------------------------------

AAO Improvement Order

    An AAO will be eligible to participate (subject to Chapter V,
Section 18 of the BOX Rules) in any Improvement Auctions that may occur
when the AAO is on the opposite side of the market from the order
seeking improvement and the AAO Limit Price is equal to the National
Best Bid or Offer (``NBBO''). When this situation occurs, the BOX
trading engine will automatically create a new order (the ``AAO
Improvement Order'') at the end of the auction phase, but prior to any
trade allocations, with the following terms:
    (1) The quantity of the AAO Improvement Order shall be the lesser
of the remaining quantity on the BOX Book at the AAO Limit Price or the
quantity of the order seeking improvement in the auction; and
    (2) The price of the AAO Improvement Order shall be equal to the
price of the best Improvement Order, Primary Improvement Order or
unrelated order (on the same side of the market as the AAO).

Trade Processing of AAO

    During an Improvement Auction, if the number of contracts executed
in the Improvement Auction against the AAO Improvement Order is less
than the quantity of AAO Limit Order, then, prior to the processing of
any other orders on the same series on the AAO Limit Order side of the
market, the quantity of the AAO Limit Order will be decremented on the
BOX Book by the size of the executed quantity of the AAO Improvement
Order. Any residual quantity that remains after part of an AAO has
traded (either on the BOX Book or in the Improvement Auction) will
continue to be eligible to trade in any subsequent Improvement
Auctions. In addition, the residual quantity will maintain its priority
on the BOX Book in accordance with Chapter V, Section 16 of the BOX
Rules.
    Any AAO Improvement Order created by the BOX Trading Host will be
assigned the time priority of the related AAO Limit Order. As such, the
AAO Improvement Order is granted time priority at its relevant price
level in an Improvement Auction.
    Any modification to the AAO Maximum Improvement Price that causes
the rounded AAO Limit Price to change or any increase in the quantity
of the AAO will cause a new time priority to be assigned to the AAO
Limit Order on the BOX Book. Any changes to the AAO Maximum Improvement
Price that do not effect the AAO Limit Price will not cause a change to
the time priority of the original order.
    Additionally, a new AAO received in a particular series that is on
the opposite side of the market from another AAO, which is already on
the BOX Book, and is marketable at the AAO Maximum Improvement Price of
the other booked AAO (e.g., a buy AAO is on the BOX Book with a Limit
Price bid of $2.00 with an AAO Maximum Improvement Price of $2.03 and a
new sell AAO is received by the BOX Trading Host with an AAO Maximum
Improvement Price of $2.02), will be matched at the mid-point of the
two AAO Maximum Improvement Prices, rounded to the nearest penny
increment in the favor of the AAO that is already on the BOX Book. The
quantity of the resulting trade will be for the lesser quantity of the
two AAOs.
    Finally, AAOs may be entered for any account type except for the
accounts of BOX Market Makers.
    The following examples demonstrate how an AAO will work. For all
examples, assume an AAO is entered into the Trading Host to buy 100
contracts of XYZ at a Maximum Improvement Price of $1.03 (referred to
in the following examples as the ``Original AAO''). The Original AAO
will be rounded to $1.00 (i.e., the nearest minimum trading increment
in accordance with Chapter V, Section 6 of BOX Rules) and the AAO Limit
Order placed on the BOX Book at $1.00.

    Example 1. For this example, assume the Original AAO is the only
order resting on the BOX Book at $1.00. An order to sell 70
contracts at market has commenced an Improvement Auction at $1.01.
At the end of the auction, the best Improvement Order is an order to
buy 10 contracts of XYZ at $1.02. The Trading Host creates an AAO
Improvement Order for 70 contracts at $1.02 with the Original AAO
Limit Order's time priority which trades against the customer in the
Improvement Auction. The remaining 30 contracts from the Original
AAO will remain on the BOX Book at their original time priority.
    Example 2. In this example, everything is the same as Example 1
except that the market order to sell XYZ is for 100 contracts. The
full quantity of the Original AAO (i.e., 100 contracts) will be
executed at $1.02.
    Example 3. For this example, assume there is another AAO buy
order resting on the BOX Book at $1.00 that has time priority over
the Original AAO (referred to in this example as the ``2nd AAO'').
The 2nd AAO is for 50 contracts and its AAO Maximum Improvement
Price is $1.04. At the end of an Improvement Auction for 90
contracts to be sold at market, the best Improvement Order is for 10
contracts at $1.02. Two AAO Improvement Orders are created by the
BOX Trading Host: one for 100 contracts at $1.02 and one for 50
contracts at $1.02. All 50 contracts from the 2nd AAO will be
consummated first at $1.02. The remaining 40 contracts will be
executed at $1.02 with the Original AAO. The remaining 60 contracts
from the Original AAO will remain on the BOX Book at their original
time priority.
    Example 4. For this example assume a second AAO buy order is
resting on the BOX Book at $1.00 that does not have time priority
over the Original AAO (referred to in this example as the ``2nd
AAO''). The 2nd AAO is for 50 contracts with an AAO Maximum
Improvement Price is $1.04. A market order to sell 75 contracts of
XYZ is entered into the Trading Host and an Improvement Auction
commences. During the Improvement Auction an Improvement Order to
buy XYZ is entered at $1.01. Upon completion of the Improvement
Auction, the 50 contracts of the 2nd AAO will be fully executed at
$1.01 and

the Original AAO will fill the remaining 25 contracts of the market
order to sell at $1.01. Even though the Original AAO has time
priority over the 2nd AAO, the 2nd AAO will be filled first because
it has a higher AAO Maximum Improvement Price ($1.04 vs. $1.03) than
the Original AAO.
    Example 5. For this example, assume that while the Original AAO
is resting on the BOX Book, but prior to an Improvement Auction
commences, another AAO to sell 80 XYZ is entered into the Trading
Host at $1.01 (referred to in this example and in Example 6 as the
``2nd AAO''). These two orders will immediately be matched and
traded at $1.02, the mid-point of the two AAO Maximum Improvement
Prices. The remaining 20 contracts from the Original AAO will remain
on the BOX Book with its original time price priority.
    Example 6. For this example, assume everything is the same as in
Example 5 except the 2nd AAO to sell 80 XYZ is entered into the
Trading Host at $1.02. The executions will remain the same as in
Example 5 except the price will be rounded (the midpoint of $1.02
and $1.03 is $1.025) to the nearest penny increment towards the
favor of the Original AAO. Since the Original AAO was already on the
BOX Book, the trade will execute at $1.02. The remaining 20
contracts from the Original AAO will remain on the BOX Book with its
original time price priority.

Conclusion

    As shown by the above examples, the AAO causes no detriment to
customers or the markets as a whole, will increase the number of
Improvement Orders that will be available to participate in an
Improvement Auction and thus creates a greater possibility for better
execution prices on all orders placed on BOX.
2. Statutory Basis
    The proposal is consistent with the requirements of Section 6(b) of
the Act,\6\ in general, and Section 6(b)(5) of the Act,\7\ in
particular, in that it makes it easier for non-professional customers
to participate in Improvement Auctions, it is generally designed to
promote just and equitable principles of trade, to prevent fraudulent
and manipulative acts and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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 that is 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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which BSE consents, the Commission shall: (a) By order approve such
proposed rule change, or (b) institute proceedings to determine whether
the proposed rule change should be 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 No. SR-BSE-2006-56 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.
    All submissions should refer to File Number SR-BSE-2006-56. 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 inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the BSE. 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-BSE-2006-56 and should be submitted on or before March
5, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-2250 Filed 2-9-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 162 (Tuesday, August 23, 2022)]
[Notices]
[Page 51665]
[FR Doc No: 2022-18129]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. AD22-11-000; AD21-9-000]

Office of Public Participation Fundamentals for Participating in
FERC Matters; Supplemental Notice of Workshop: WorkshOPP on Filing
Comments

    On July 11, 2022, the Federal Energy Regulatory Commission Office
of Public Participation (OPP) issued a notice of an August 30, 2022
from 2:00 p.m. to 3:00 p.m. Eastern time, virtual workshop to discuss,
how members of the public including consumers and consumer advocates
can file comments on the record using FERC Online applications.
    The workshop will include a video demonstration of steps involved
in filing a comment in a rulemaking proceeding, followed by a
presentation of useful tips for using the Commission's online
applications and a question-and-answer portion of the workshop. The
workshop will provide information on the commenting process to
facilitate increased public participation in Commission processes and
decision-making.
    The workshop will be open for the public to attend, and there is no
fee for attendance. Further details on the agenda, including
registration information, can be found on the OPP website. Information
on this technical workshop will also be posted on the Calendar of
Events on the Commission's website, www.ferc.gov, prior to the event.

                   WorkshOPP on Filing Comments Agenda
------------------------------------------------------------------------

------------------------------------------------------------------------
2:05-2:15 p.m................  Introduction.
2:15-2:25 p.m................  FERC Fundamentals and FERC Online
                                Applications.
2:25-2:35 p.m................  Video: How to file comments in a
                                Rulemaking using eFiling.
2:35-2:50 p.m................  Tips for FERC Online Applications.
2:50-3:00 p.m................  Questions and Answers.
------------------------------------------------------------------------

    The workshop will be accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to [email protected] or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For more information about the workshop, please contact the
Commission's Office of Public Participation at<PHONE_NUMBER> or send an
email to [email protected]. To submit a question that you would like
answered during the workshop, please email [email protected].

    Dated: August 17, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-18129 Filed 8-22-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 18, 2007 (Volume 72, Number 201)]
[Notices]
[Page 59141]
[DOCID:fr18oc07-92]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Receipt of Noise Compatibility Program and Request for Review

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) announces that it is
reviewing a proposed noise compatibility program update that was
submitted for Baltimore/Washington International Thurgood Marshall
Airport under the provisions of 49 U.S.C. 47504 et. seq (the Aviation
Safety and Noise Abatement Act, hereinafter referred to as ``the Act'')
and 14 CFR part 150 by the Maryland Aviation Administration. This
program was submitted subsequent to a determination by FAA that
associated noise exposure maps submitted under 14 CFR part 150 for
Baltimore/Washington International Thurgood Marshall Airport were in
compliance with applicable requirements, effective April 3, 2006,
Federal Register Doc. 06-3624. The proposed noise compatibility program
update will be approved or disapproved on or before March 28, 2008.

DATES: Effective Date: The effective date of the start of FAA's review
of the noise compatibility program update is October 1, 2007. The
public comment period ends November 30, 2007.

FOR FURTHER INFORMATION CONTACT: Jennifer Mendelsohn, Eastern Region,
Washington Airports District Office, Federal Aviation Administration,
23723 Air Freight Lane, Suite 210, Dulles, Virginia 20166, Telephone:
703-661-1362. Comments on the proposed noise compatibility program
update should also be submitted to the above office.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA is
reviewing a proposed noise compatibility program update for Baltimore/
Washington International Thurgood Marshall Airport, which will be
approved or disapproved on or before March 28, 2008. This notice also
announces the availability of this program for public review and
comment.
    An airport operator who has submitted noise exposure maps that are
found by FAA to be in compliance with the requirements of Federal
Aviation Regulations (FAR) Part 150, promulgated pursuant to the Act,
may submit a noise compatibility program for FAA approval which sets
forth the measures the operator has taken or proposes to reduce
existing non-compatible uses and prevent the introduction of additional
non-compatible uses.
    The FAA has formally received the noise compatibility program
update for Baltimore/Washington International Thurgood Marshall
Airport, effective on October 1, 2007. The airport operator has
requested that the FAA review this material and that the noise
mitigation measures, to be implemented jointly by the airport and
surrounding communities, be approved as a noise compatibility program
update under section 47504 of the Act. Preliminary review of the
submitted material indicates that it conforms to FAR Part 150
requirements for the submittal of noise compatibility programs, but
that further review will be necessary prior to approval or disapproval
of the program. The formal review period, limited by law to a maximum
of 180 days, will be completed on or before March 28, 2008.
    The FAA's detailed evaluation will be conducted under the
provisions of 14 CFR part 150, section 150.33. The primary
considerations in the evaluation process are whether the proposed
measures may reduce the level of aviation safety or create an undue
burden on interstate or foreign commerce, and whether they are
reasonably consistent with obtaining the goal of reducing existing non-
compatible land uses and preventing the introduction of additional non-
compatible land uses.
    Interested persons are invited to comment on the proposed program
with specific reference to these factors. All comments relating to
these factors, other than those properly addressed to local land use
authorities, will be considered by the FAA to the extent practicable.
Copies of the noise exposure maps and the proposed noise compatibility
program update are available for examination at the following
locations:

Federal Aviation Administration, Eastern Region--Airports Division, 1
Aviation Plaza, Jamaica, New York 11434.
Federal Aviation Administration, Washington Airports District Office,
23723 Air Freight Lane, Suite 210, Dulles, Virginia 20166.
Maryland Aviation Administration, Division of Noise, Real Estate and
Land Use Compatibility, 991 Corporate Boulevard, Linthicum, MD 21090.

    Questions may be directed to the individual named above under the
heading, FOR FURTHER INFORMATION CONTACT.

    Issued in Dulles, Virginia, on October 1, 2007.
Terry J. Page,
Manager, Washington Airports District Office.
[FR Doc. 07-5151 Filed 10-17-07; 8:45 am]

BILLING CODE 4910-13-M


ABAMECTIN FOCUS MEETING AGENDA 	2/14/2013
Introductions

   1.    Goals of the Focus meeting
--ID areas of uncertainty which may affect risk assessment
--acquire information necessary to conduct a sound risk assessment

   2.    Registration Review Schedule
--abamectin docket opens _____________________
--PWP publication _______________________
--FWP publication _______________________
--DCI expected to be issued ____________________

   3.    Brief overview of cheminova's, nufarm's, tide's, ensystex's, and celsius property's registrations (presented by each technical registrant in turn)

   4.    Overview of key uncertainties which may affect registration review (by EPA)
--label uncertainties --
      master label?
      Non-specified maximum use rates in the LUIS report

--data requirements
--HASPOC findings for subchronic inhalation tox study and subchronic dermal tox study

   5.    Other outstanding issues
--current labels -- grape REI and new environmental hazards section with surface water text (RD)

   6.    Questions from abamectin registrants for EPA


 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

February 20, 2007

MEMORANDUM

SUBJECT:   	Triadimefon/Triadimenol RED/TRED (Chemical No. 109901 and
127201).  	Close-out of the Reregistration Eligibility Decision/
Tolerance Reassessment 	Eligibility Decision (TRED) document.

This memorandum serves to finalize the Agency’s actions regarding the
Triadimefon Reregistration Eligibility Decision (RED) and Triadimenol
Tolerance Reassessment Eligibility Decision (TRED) document.  During the
public comment period for the triadimefon/triadimenol RED/TRED document,
the Agency received and reviewed several comments submitted from both a
private citizen and the technical registrant (Bayer CropScience).  Thus,
a response to comments document addressing the comments submitted in
response to the RED/TRED document were prepared by the Agency to address
all concerns.  As a result, the Agency considers the
triadimefon/triadimenol decision document to be complete and final.  The
response to comments document addressed, herein, as well as all other
supporting documents, are available in the public docket for triadimefon
(EPA-HQ-OPP-2005-0258) and for triadimenol (EPA-HQ-OPP-2006-0038) in the
Agency’s electronic docket on the internet at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov .


[Federal Register Volume 75, Number 225 (Tuesday, November 23, 2010)]
[Notices]
[Pages 71427-71428]
[FR Doc No: 2010-29443]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13867-000]

Clean River Power 11, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

November 16, 2010.
    On October 15, 2010, Clean River Power 11, LLC filed an application
for

a preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of the Swamp Creek
Hydroelectric Project (Swamp Creek project) to be located on Swamp
Creek in the vicinity of Glacier, in Whatcom County, Washington. The
sole purpose of a preliminary permit, if issued, is to grant the permit
holder priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    The proposed project will consist of the following: (1) A 50-foot-
long, 8-foot-high reinforced concrete diversion weir on Swamp Creek;
(2) a 45-foot-long, 15-foot-wide, 12-foot-high reinforced concrete
intake structure adjacent to the weir with a trash rack, fish screen,
and closure gate; (3) a 0.15-acre impoundment created by the weir; (4)
a 5,200-foot-long, 3-foot-diameter steel penstock from the intake
structure to the powerhouse; (5) a 60-foot-long, 40-foot-wide
reinforced concrete powerhouse containing one horizontal impulse
turbine with a capacity of 3.5 megawatts (MW); (6) a 40-foot-long,
concrete and rip-rap-lined tailrace channel to return flows to Swamp
Creek; (7) a 4.6/55 kilovolt (kV) three stage step up transformer; (8)
an approximately 6.75-mile-long, 55-kV transmission line which will tie
into an undetermined interconnection; and (9) appurtenant facilities.
The estimated annual generation of the Swamp Creek project would be
15.0 gigawatt-hours.
    Applicant Contact: Ramya Swaminthan, Clean River Power 11, LLC, 33
Commercial St., Gloucester, MA 01930; phone:<PHONE_NUMBER>.
    FERC Contact: Ryan Hansen,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13867-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-29443 Filed 11-22-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 13, 2006 (Volume 71, Number 9)]
[Notices]
[Page 2210]
[DOCID:fr13ja06-70]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-167-000]

Texas Eastern Transmission, LP; Notice of Proposed Changes in
FERC Gas Tariff

January 6, 2006.
    Take notice that on December 30, 2005, Texas Eastern Transmission,
LP (Texas Eastern) tendered for filing as part of its FERC Gas Tariff,
Seventh Revised Volume No. 1 and First Revised Volume No. 2, revised
tariff sheets, as listed on Appendix B to the filing, to become
effective February 1, 2006.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-294 Filed 1-12-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Proposed Rules]
[Pages 51851-51857]
[FR Doc No: 2021-19896]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 59

[EPA-HQ-OAR-2006-0971; FRL-7966-02-OAR]
RIN 2060-AU94

National Volatile Organic Compound Emission Standards for Aerosol
Coatings Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) is proposing to
amend the National Volatile Organic Compound (VOC) Emission Standards
for Aerosol Coatings, which establishes reactivity-based emission
standards for the aerosol coatings category (aerosol spray paints)
under the Clean Air Act (CAA). In this action, the EPA is proposing to
update coating category product-weighted reactivity limits for aerosol
coatings categories; add new compounds and reactivity factors (RFs);
update existing reactivity values; revise the default RF; amend the
thresholds for compounds regulated by this document; and add electronic
reporting provisions.

DATES:
    Comments. Comments must be received on or before November 16, 2021.
Under the Paperwork Reduction Act (PRA), comments on the information
collection provisions are best assured of consideration if the Office
of Management and Budget (OMB) receives a copy of your comments on or
before October 18, 2021.
    Public Hearing: If anyone contacts us requesting a public hearing
on or before September 22, 2021, the Agency will hold a virtual public
hearing. See SUPPLEMENTARY INFORMATION for information on requesting
and registering for a public hearing.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OAR-2006-0971, 40 Code of Federal Regulations (CFR) part 59, subpart E,
by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
     Email<EMAIL_ADDRESS>Include Docket ID No. EPA-
HQ-OAR-2006-0971 in the subject line of the message.
     Fax:<PHONE_NUMBER>. Attention Docket ID No. EPA-HQ-OAR-
2006-0971.
    Instructions: All submissions received must include the Docket ID
No. EPA-HQ-OAR-2006-0971 for this rulemaking. Comments received may be
posted without change to https://www.regulations.gov/, including any
personal information provided. For detailed instructions on sending
comments and additional information on the rulemaking process, see the
SUPPLEMENTARY INFORMATION section of this document. Out of an abundance
of caution for members of the public and our staff, the EPA Docket
Center and Reading Room closed to public visitors on March 31, 2020 to
reduce the risk of transmitting COVID-19 Our Docket Center staff will
continue to provide remote customer service via email, phone, and
webform. The Agency encourages the public to submit comments via
https://www.regulations.gov/or email, as there is a temporary
suspension of mail delivery to EPA, and no hand deliveries are
currently accepted. For further information on EPA Docket Center
services and the current status, please visit us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For information about the National
Volatile Organic Compound Emission Standards for Aerosol Coatings,
contact Ms. J. Kaye Whitfield, U.S. EPA, Office of Air Quality Planning
and Standards, Sector Policies and Programs Division, Minerals and
Manufacturing Group (D243-04), Research Triangle Park, North Carolina
27711; telephone number:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; and
email address<EMAIL_ADDRESS>For questions related to
enforcement, contact Mr. John Cox, Office of Enforcement and Compliance
Assurance, U.S. Environmental Protection Agency, U.S. EPA WJC South
Building (2221A), Pennsylvania Avenue NW, Washington, DC 20460;
telephone number;<PHONE_NUMBER>); and email address<EMAIL_ADDRESS>
For questions regarding electronic reporting, contact Ms. Theresa Lowe,
U.S. EPA, Office of Air Quality Planning and Standards, Sector Policies
and Programs Division, Measurement Policy Group (D243-05), Research
Triangle Park, North Carolina 27711; telephone number:<PHONE_NUMBER>;
and email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Entities Potentially Affected by This Action. The entities
potentially affected by this regulation include manufacturers,
processors, wholesale distributors, or importers of aerosol coatings
for sale or distribution in the United States, or manufacturers,
processors, wholesale distributors, or importers who supply the
entities listed above with aerosol coatings for sale or distribution in
interstate commerce in the United States. The entities potentially
affected by this proposed action include those listed in the North
American Industry Classification System codes 32551 and 325998. This
list is not intended to be exhaustive, but rather provides a guide for
entities likely to be affected by this action. To determine whether you
would be affected by this action, you should examine the applicable
industry description in section I.E of the promulgation preamble,
published at 73 FR 15604 (March 24, 2008). If you have any questions
regarding the applicability of this action to a particular entity,
consult the appropriate EPA contact listed in the FOR FURTHER
INFORMATION CONTACT section of this notice.
    Obtaining a copy of this document and other related information. In
addition to being available in the docket, an electronic copy of this
action is available on the internet. Following signature by the EPA
Administrator, the EPA will post a copy of this proposed action at
https://www.epa.gov/stationary-sources-air-pollution/aerosol-coatings-national-volatile-organic-compound-emission. Following publication in
the Federal Register, the EPA will post the Federal Register version of
the proposal and key technical documents at this same website.
    The proposed changes to the regulatory text in the CFR that would
be necessary to incorporate the changes proposed in this action are set
out the document titled Proposed Regulation Edits for 40 CFR part 59,
subpart E in the docket for this action (Docket ID No.

EPA-HQ-OAR-2006-0971). This document includes the specific proposed
amendatory language for revising the CFR and, for the convenience of
interested parties, a redline version of the regulations. Following
signature by the EPA Administrator, the EPA will also post a copy of
this memorandum and the attachment to https://www.epa.gov/stationary-sources-air-pollution/aerosol-coatings-national-volatile-organic-compound-emission.
    Participation in virtual public hearing. Please note that the EPA
is deviating from its typical approach for public hearings because the
President declared a national emergency. Due to the current Centers for
Disease Control and Prevention (CDC) recommendations, as well as state
and local orders for social distancing to limit the spread of COVID-19,
the EPA cannot hold in-person public meetings at this time.
    To request a virtual public hearing, contact the public hearing
team at<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>If
requested, the virtual hearing will be held on October 4, 2021. The
hearing will convene at 9:00 a.m. Eastern Time (ET) and will conclude
at 3:00 p.m. ET. The EPA may close a session 15 minutes after the last
pre-registered speaker has testified if there are no additional
speakers. The EPA will announce further details at https://www.epa.gov/stationary-sources-air-pollution/aerosol-coatings-national-volatile-organic-compound-emission.
    Upon publication of this document in the Federal Register, the EPA
will begin pre-registering speakers for the hearing, if a hearing is
requested. To register to speak at the virtual hearing, please use the
online registration form available at https://www.epa.gov/stationary-sources-air-pollution/aerosol-coatings-national-volatile-organic-compound-emission or contact the public hearing team at<PHONE_NUMBER>
or by email at<EMAIL_ADDRESS>The last day to pre-register
to speak at the hearing will be September 29, 2021. Prior to the
hearing, the EPA will post a general agenda that will list pre-
registered speakers in approximate order at: https://www.epa.gov/stationary-sources-air-pollution/aerosol-coatings-national-volatile-organic-compound-emission.
    The EPA will make every effort to follow the schedule as closely as
possible on the day of the hearing; however, please plan for the
hearings to run either ahead of schedule or behind schedule.
    Each commenter will have 5 minutes to provide oral testimony. The
EPA encourages commenters to provide the EPA with a copy of their oral
testimony electronically (via email) by emailing it to
<EMAIL_ADDRESS>The EPA also recommends submitting the text of
your oral testimony as written comments to the rulemaking docket.
    The EPA may ask clarifying questions during the oral presentations
but will not respond to the presentations at that time. Written
statements and supporting information submitted during the comment
period will be considered with the same weight as oral testimony and
supporting information presented at the public hearing.
    Please note that any updates made to any aspect of the hearing will
be posted online at https://www.epa.gov/stationary-sources-air-pollution/aerosol-coatings-national-volatile-organic-compound-emission.
While the EPA expects the hearing to go forward as set forth above,
please monitor our website or contact the public hearing team at (888)
372-8699 or by email at<EMAIL_ADDRESS>to determine if there
are any updates. The EPA does not intend to publish a document in the
Federal Register announcing updates. If you require the services of a
translator or a special accommodation such as audio description, please
pre-register for the hearing with the public hearing team and describe
your needs by September 24, 2021. The EPA may not be able to arrange
accommodations without advanced notice.
    Docket. The EPA has established a docket for this rulemaking under
Docket ID No. EPA-HQ-OAR-2006-0971. All documents in the dockets are
listed in https://www.regulations.gov/. Although listed, some
information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy. Publicly available docket materials are available either in the
docket for this action, Docket ID No. EPA-HQ-OAR-2006-0971, or
electronically at https://www.regulations.gov/.
    Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2006-0971. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at https://www.regulations.gov/. Do not submit electronically
any information that you consider to be CBI or other information whose
disclosure is restricted by statute. This type of information should be
submitted by mail as discussed below.
    The EPA may publish any comment received to its public docket.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    The https://www.regulations.gov/ website allows you to submit your
comment anonymously, which means the EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send an email comment directly to the EPA without going through
https://www.regulations.gov/, your email address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the internet. If you submit an
electronic comment, the EPA recommends that you include your name and
other contact information in the body of your comment and with any
digital storage media you submit. If the EPA cannot read your comment
due to technical difficulties and cannot contact you for clarification,
the EPA may not be able to consider your comment. Electronic files
should not include special characters or any form of encryption and be
free of any defects or viruses. For additional information about the
EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets.
    The EPA is temporarily suspending its Docket Center and Reading
Room for public visitors, with limited exceptions, to reduce the risk
of transmitting COVID-19. Our Docket Center staff will continue to
provide remote customer service via email, phone, and webform. The EPA
encourages the public to submit comments via https://www.regulations.gov/ as there may be a delay in processing mail and
faxes. Hand deliveries or couriers will be received by scheduled
appointment only. For further information and updates on EPA Docket
Center services, please visit us online at https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from

the CDC, local area health departments, and our Federal partners so
that the Agency can respond rapidly as conditions change regarding
COVID-19.
    Submitting CBI. Do not submit information containing CBI to the EPA
through https://www.regulations.gov/ or email. Clearly mark the part or
all the information that you claim to be CBI. For CBI information on
any digital storage media that you mail to the EPA, mark the outside of
the digital storage media as CBI and then identify electronically
within the digital storage media the specific information that is
claimed as CBI. In addition to one complete version of the comments
that includes information claimed as CBI, you must submit a copy of the
comments that does not contain the information claimed as CBI directly
to the public docket through the procedures outlined in Instructions
above. If you submit any digital storage media that does not contain
CBI, mark the outside of the digital storage media clearly that it does
not contain CBI. Information not marked as CBI will be included in the
public docket and the EPA's electronic public docket without prior
notice. Information marked as CBI will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2. Send or deliver
information identified as CBI only to the following address: OAQPS
Document Control Officer (C404-02), OAQPS, U.S. Environmental
Protection Agency, Research Triangle Park, North Carolina 27711,
Attention Docket ID No. EPA-HQ-OAR-2006-0971. Note that written
comments containing CBI and submitted by mail may be delayed and no
hand deliveries will be accepted.
    Organization of this document. The information in this preamble is
organized as follows:

I. Background
II. What amendments have been made to the National Volatile Organic
Compound Emission Standards for Aerosol Coatings Rule?
III. Summary of Proposed Amendments to the National Volatile Organic
Compound Emission Standards for Aerosol Coatings
    A. Table 1 to Subpart E of Part 59.--Product-Weighted Reactivity
Limits by Coatings Category
    B. Table 2 to Subpart E of Part 59.--2A Reactivity Factors, 2B
Aliphatic Hydrocarbon Solvent Mixtures, and 2C Aromatic Hydrocarbon
Solvent Mixtures
    C. The Default Reactivity Factor
    D. VOC Regulated Under This Rule
    E. Electronic Reporting of Notifications and Reports
    F. Test Methods
IV. Summary of Impacts
    A. Environmental Impacts
    B. Energy Impacts
    C. Cost and Economic Impacts
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175 Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. Background

    The EPA promulgated ``The National Volatile Organic Compound
Emission Standards for Aerosol Coatings,'' in 2008 (73 FR 15604; March
24, 2008) and codified the action at 40 CFR part 59, subpart E
(sections 59.500- 59.516). The rule established nationwide VOC
reactivity-based standards for the aerosol coatings source category.
The statutory authority for this action is provided by section 183(e)
of the CAA, as amended (42 U.S.C. 7401 et seq.). Section 183(e) of the
CAA requires the EPA to control VOC emissions from certain categories
of consumer and commercial products for purposes of reducing VOC
emissions contributing to ozone formation and nonattainment of the
ozone national ambient air quality standards (NAAQS).
    The EPA and states typically have promulgated rules for regulating
VOCs from consumer products based upon reductions of VOC content in the
products by mass. One state, California, promulgated a regulation for
VOC emissions from aerosol coatings based on a relative reactivity
approach. The EPA promulgated a national rule based upon the relative
reactivity approach after concluding that the approach could achieve
more reduction in ozone formation than may be achieved by a mass-based
approach for this source category. The reactivity-based approach
requires the EPA to revise the regulatory definition of VOC to include
compounds that would otherwise be exempt, to account for all reactive
compounds in aerosol coatings that contribute to ozone formation.
Therefore, certain compounds that would not be VOC under the otherwise
applicable definition for other purposes, do count towards the
applicable reactivity-based limits of the aerosol coatings standards.
    Regulated entities, encompassing all steps in aerosol coatings
operations, include manufacturers, processors, wholesale distributors,
or importers of aerosol coatings or their suppliers. There are
approximately 46 regulated entities; however, two aerosol coatings
companies account for about 70 percent of the U.S. market.\1\
---------------------------------------------------------------------------

    \1\ Email Conversation, American Coatings Association, March 29,
2021.
---------------------------------------------------------------------------

II. What amendments have been made to the National Volatile Organic
Compound Emission Standards for Aerosol Coatings Rule?

    The national emission standards for aerosol coatings (74 FR 29595;
June 23, 2009) has been amended several times. In accordance with
section 59.511(j), the EPA responded to an industry petition and added
128 compounds, corresponding reactivity factors, and Chemical Abstract
Service (CAS) numbers for each compound or class of compounds listed in
Table 2A. In addition, the Agency changed the definition of VOC in part
51 to clarify that compounds that are excluded from the definition of
VOC under both 40 CFR 51.100(s)(1) and (s)(5) are to be counted as VOC
for the purposes of determining compliance with the aerosol coatings
reactivity rule in 40 CFR part 59, subpart E. In the same action, the
EPA amended section 59.511(g) to ensure that both the certifying entity
and the regulated entity have full knowledge of responsibilities
assumed by the certifying entity. In a later action, the EPA responded
to a second petition from industry and added three new compounds,
reactivity factors, and CAS numbers to Table 2A of the rule. See 77 FR
14279 (March 9, 2012).

III. Summary of Proposed Amendments to the National Volatile Organic
Compound Emission Standards for Aerosol Coatings

    The EPA is proposing to amend Tables 1 and 2 to subpart E of part
59, the default reactivity factor, VOC regulated by the rule, and
requirements for submitting reports. The Agency is proposing these
changes, in part, to respond to petitions from American Coatings
Association (ACA) requesting revisions to the standards that promote
consistency and uniformity, where appropriate, between California Air
Resources Board (CARB) and national aerosol coatings regulations. For
more information on the petitions submitted

by ACA to the Agency, see the docket for this action, Docket ID No.
EPA-HQ-OAR-2006-0971.

A. Table 1 to Subpart E of Part 59.--Product-Weighted Reactivity Limits
by Coatings Category

    The national rule establishes product-weighted reactivity limits,
listed in Table 1, for each coating category. Compliance with these
limits is determined by the mass weighted sum of the reactivity values
of the VOC ingredients in the product. In this action, the Agency is
proposing to update both the reactivity values of individual VOCs (in
Table 2) and the limits for each coating category (in Table 1). These
changes are intended to update the relative reactivity scale that
underlies both the reactivity factors and limits; to further decrease
the contribution of aerosol coatings to ozone formation; and to make
the national rule consistent with the California regulation to improve
ease of compliance and implementation.
    When considering updates to coating categories and emission limits
in Table 1, the EPA consulted with CARB and reviewed CARB's rationale
\2\ for changes made to California's aerosol coatings regulations since
promulgation of the EPA national regulation. The Agency then met with
ACA to discuss their concerns. Based on the outcome of these
consultations, the Agency is proposing to adopt category names and
limits identical to those in the CARB aerosol coatings regulation. The
proposed amendments will increase clarity and promote consistency
between California and national aerosol coatings regulations, one of
the stated objectives of the ACA petition.
---------------------------------------------------------------------------

    \2\ Proposed Amendments to the Antiperspirant and Deodorants
Regulation, the Consumer Products Regulation, the Aerosol Coating
Products Regulation, the Tables of MIR Values, Test Method 310, and
Proposed Repeal of the Hairspray Credit Program; Date of Release:
August 7, 2013, Scheduled for Consideration: September 26, 2013.
---------------------------------------------------------------------------

    Accordingly, the Agency is proposing to combine two sets of
coatings subcategories into two main categories and to add
corresponding limits for those categories, as follows:
    The subcategories ``enamel,'' ``lacquer,'' and ``clear or
metallic'' coatings will be subsumed under the category heading,
``Hobby/Model/Craft Coatings,'' and the category limit will be set
equal to 1.6 g O3/g VOC. The subcategories ``clear'' and
``pigmented'' coatings will be subsumed under the category heading,
``Shellac Sealers,'' with the category limit set equal to 1.00 g
O3/g VOC.
    The EPA also is proposing to add six new specialty coating
categories and corresponding limits for those categories, as follows:
    ``Electrical/Electronic/Conformal Coatings,'' with a category limit
set equal to 2.00 O3/g VOC; ``Flexible Coatings,'' with a
limit equal to 1.60 O3/g VOC; ``Mold Release Coatings,''
with a limit equal to 1.10 O3/g VOC; ``Rust Converter,''
with a limit equal to 1.10 O3/g VOC; ``Two Component
Coating,'' with a limit equal to 1.20 O3/g VOC; and
``Uniform Finish Coating,'' with a limit equal to 1.30 O3/g
VOC.
    For a complete list of proposed changes to Table 1, see Proposed
Regulation Edits for 40 CFR part 59, subpart E, located in the docket
for this action, EPA Docket ID No. EPA-HQ-OAR-2006-0971.

B. Table 2 to Subpart E of Part 59.--2A Reactivity Factors, 2B
Aliphatic Hydrocarbon Solvent Mixtures, and 2C Aromatic Hydrocarbon
Solvent Mixtures

    The EPA is proposing to amend Tables 2A, 2B, and 2C by adding new
compounds and RFs and updating existing reactivity values. The proposed
changes will provide uniformity between CARB \3\ and national aerosol
coatings regulations (73 FR 15604). California uses maximum incremental
reactivity (MIR) values \4\ as the basis for its aerosol coatings
regulations. In the national rule, the Agency uses the term
``reactivity factor'' and sets the value equal to the MIR or upper
limit MIR used by CARB.
---------------------------------------------------------------------------

    \3\ Title 17, California's Regulation, Division 3, Chapter 1,
Subchapter 8.5, Article 3, Aerosol Coatings Products, Sections
94520-94528 (Amended September 17, 2014).
    \4\ Title 17, CCR, Article 1, Tables of Maximum Incremental
Reactivity Values, Sections 94700-94701 (Amended September 17,
2014).
---------------------------------------------------------------------------

    In accordance with 40 CFR part 59, subpart E, section 59.511(j),
ACA submitted petitions requesting the EPA add 17 new compounds and RFs
to Table 2A and update the RF of one existing compound mixture on Table
2B. The petitioners provided the chemical names, CAS numbers, a
statement certifying the intent to use the compounds in aerosol
coatings products, and information allowing the EPA to evaluate the
reactivity of the compounds and assign RF values. Of the 17 new
compound additions to Table 2A, CARB has assigned MIR values for 15 of
the compounds in California's aerosol coatings regulation,\5\ which the
Agency is proposing to adopt in this action. The proposed RFs of the
two remaining compounds are equal to 0.04 g O3/g VOC for
trans-1-chloro-3,3,3-trifluoropropene (HFO-1233zdE), CAS 102687-65-0,
based on MIR values from Carter \6\; and 0.71 g O3/g VOC for
diethyl carbonate, CAS 105-58-8, based on MIR values derived by
Venecek.\7\
---------------------------------------------------------------------------

    \5\ Ibid.
    \6\ Carter, William (2009). Investigation of Atmospheric Ozone
Impacts of Trans 1-Chloro-3,3,3-Trifluoropropene, Final Report.
Riverside, California: Center for Environmental Research and
Technology, University of California.
    \7\ Venecek, Melissa (2020). Estimating Maximum Incremental
Reactivity for Diethyl Carbonate. Final Report. Sacramento,
California: Technical Development Section, Consumer Products and Air
Quality Assessment Branch, Air Quality Planning and Science
Division, California Air Resources Board.
---------------------------------------------------------------------------

    One of the compounds being added, dipropylene glycol monomethyl
ether, CAS 34590-94-8, is a mixture of isomers. The compound, 2-[2-
methoxypropoxy]-1-propanol, CAS 13588-28-8, which is an isomer of
dipropylene glycol monomethyl ether, is already on Table 2A. Both
compounds are assigned the same RF.
    In addition to adding the identified compounds, the Agency is
proposing to update all of the existing reactivity factors listed in
Table 2A, 2B, and 2C to align with the MIR values in the current
California regulation.\8\ This change is necessary to maintain the
internal consistency of the relative reactivity scale and consistency
with the changes proposed for the limits in Table 1.
---------------------------------------------------------------------------

    \8\ Title 17, CCR, Sections 94700-94701.
---------------------------------------------------------------------------

    For a complete list of proposed changes to Table 2, see Proposed
Regulation Edits for 40 CFR part 59, subpart E in the docket for this
action, EPA Docket ID No. EPA-HQ-OAR-2006-0971.

C. The Default Reactivity Factor

    The ACA petition requested the EPA revise the default RF for
compounds in aerosol coatings formulations that do not have an
established RF listed in Table 2A to subpart E of part 59--Reactivity
Factors. Consistent with the EPA's methodology for setting the default
RF, if a VOC does not have an RF, then the EPA assigns the compound the
maximum RF for any compound listed in the rule. See 72 FR 38952 (July
16, 2007). Therefore, the EPA is proposing to revise the default RF to
18.50 g O3/g VOC, the highest RF in this proposed rule.
Furthermore, the EPA is proposing to require that regulated entities
include the name and CAS number of all VOCs that are assigned the
default RF, as specified in reporting requirements.
    The EPA also is proposing that, if a VOC is used in a product and
is not listed in Table 2A, but its isomer is listed in Table 2A, then
the RF of the isomer will be used. If more than one

isomer of that VOC, or mixtures of the isomers of that VOC, is listed
in Table 2A, then the highest RF associated with the listed isomers or
isomer mixtures will be used.

D. VOC Regulated Under This Rule

    In conjunction with promulgating the initial aerosol coatings
regulations, the EPA amended the regulatory definition of VOC by adding
40 CFR 51.100(s)(7), which removes the exemption of specific organic
compounds identified in paragraphs (s)(1) and (s)(5) from the
definition of VOC for purposes of compliance with the aerosol coatings
emission limits. To eliminate consideration of VOC that make de minimis
contributions to a product's reactivity, the EPA also excluded from the
applicable limits, those compounds (a) that contribute less than 0.1
percent of the product weight (regardless of their RF), and (b) that
have reactivities less than ethane and comprise less than 7.3 percent
of product weight. The EPA explained the basis for the derivation of
the 7.3 percent threshold in the original rulemaking and its
relationship to the RF for ethane and the default RF (73 FR 15604).
    In this action, the EPA is proposing to retain part (a), where
compounds that comprise less than 0.1 percent of the product weight are
excluded from the product's mass-weighted reactivity. The EPA is
proposing to eliminate part (b), the exclusion of low reactivity
compounds that comprise more than 0.1 percent but less than 7.3 percent
of the product weight. Eliminating this exclusion should have little
impact on the ability of product formulations to comply with product-
weighted reactivity limits, as the affected compounds have low RFs and
contribute a small percentage of product weight. These two proposed
actions, in combination, will make the EPA's national regulation
consistent with the CARB aerosol coatings regulation.
    When considering the elimination of VOC that make de minimis
contributions to a product's reactivity, the Agency is soliciting
comment on the proposal to retain part (a) above, where compounds that
comprise less than 0.1 percent of the product weight are excluded from
the product's mass-weighted reactivity, and eliminate part (b), the
exclusion of low reactivity compounds that comprise more than 0.1
percent but less than 7.3 percent of the product weight.

E. Electronic Reporting of Notifications and Reports

    The EPA is proposing to revise the existing aerosol coatings rule
to require that regulated entities submit electronic copies of required
notifications and reports in template format through the EPA's Central
Data Exchange (CDX) using the Compliance and Emissions Data Reporting
Interface (CEDRI), instead of the current hard copy submission
requirement. A description of the electronic data submission process is
provided in the memorandum Electronic Reporting Requirements for New
Source Performance Standards (NSPS) and National Emission Standards for
Hazardous Air Pollutants (NESHAP) Rules, available in the docket for
this action. For the nine notification and reports, (Temporary
Variances, Initial Notification, Change to Information in Initial
Notification, Response to Written Notification, Exemption Claim Initial
Notification, Exemption Claim Annual Report, Notice of Certifying
Entity to Maintain Records, Notice Rescinding Certification and
Triennial Report), the proposed rule requires that regulated entities
use the appropriate spreadsheet template to submit information to
CEDRI. A draft version of the proposed spreadsheet template for these
notifications and reports is included in the docket. The EPA
specifically requests comment on the content, layout, and overall
design of the spreadsheet template, which can be found in the docket,
EPA Docket ID No. EPA-HQ-OAR-2006-0971 and posted online at https://www.epa.gov/stationary-sources-air-pollution/aerosol-coatings-national-volatile-organic-compound-emission.
    Additionally, the EPA has identified two broad circumstances in
which it may provide extensions of the electronic reporting deadlines.
These circumstances are (1) outages of the EPA's CDX or CEDRI which
preclude a regulated entity from accessing the system and submitting
required reports, and (2) force majeure events, which are defined as
events that will be or have been caused by circumstances beyond the
control of the regulated entity from complying with the requirement to
submit a report electronically by the applicable deadline. Examples of
force majeure events are acts of nature, acts of war or terrorism, or
equipment failure or safety hazards beyond the control of the regulated
entity. The EPA is providing these potential extensions to protect
regulated entities from noncompliance in cases where they cannot
successfully submit a report by the reporting deadline for reasons
outside of their control. In both circumstances, the decision to accept
the claim of needing additional time to report is within the discretion
of the Administrator, and reporting should occur as soon as possible.
    The electronic submittal of the reports addressed in this proposed
rulemaking will increase the usefulness of the data contained in those
reports, is in keeping with current trends in data availability and
transparency, will further assist in the protection of public health
and the environment, will improve compliance by facilitating the
ability of regulated entities to demonstrate compliance with
requirements and by facilitating the ability of delegated state, local,
tribal, and territorial air agencies and the EPA to assess and
determine compliance, and will ultimately reduce burden on regulated
entities, delegated air agencies, and the EPA. Electronic reporting
also eliminates paper-based, manual processes, thereby saving time and
resources, simplifying data entry, eliminating redundancies, minimizing
data reporting errors, and providing data quickly and accurately to the
affected facilities, air agencies, the EPA, and the public. Moreover,
electronic reporting is consistent with the EPA's plan \9\ to implement
Executive Order 13563 and is in keeping with the EPA's agency-wide
policy \10\ developed in response to the White House's Digital
Government Strategy.\11\ For more information on the benefits of
electronic reporting, see the memorandum titled, Electronic Reporting
Requirements for New Source Performance Standards (NSPS) and National
Emission Standards for Hazardous Air Pollutants (NESHAP) Rules,
referenced earlier in this section.
---------------------------------------------------------------------------

    \9\ Improving Our Regulations: Final Plan for Periodic
Retrospective Reviews, August 2011. Available at:, https://www.regulations.gov/search?filter=EPA-HQ-OA-2011-0156-0154.
    \10\ E-Reporting Policy Statement for the EPA Regulations,
September 2013. Available at: https://www.epa.gov/sites/production/files/2016-03/documents/epa-ereporting-policy-statement-2013-09-30.pdf.
    \11\ Digital Government: Building a 21st Century Platform to
Better Serve the American People, May 2012. Available at: https://www.regulations.gov/document/EPA-HQ-OAR-2010-0682-0755 or https://obamawhitehouse.archives.gov/sites/default/files/omb/egov/digital-government/digital-government.html.
---------------------------------------------------------------------------

F. Test Methods

    Although the EPA is proposing no new technical standards in this
action, the Agency is soliciting comment on whether to amend this rule
to require the use of the updated versions of the two existing test
methods currently identified in the rule: CARB Method 310,
``Determination of Volatile Organic Compounds (VOC) in Consumer
Products and Reactive Organic Compounds in Aerosol Coating Products,''
updated May 25, 2018; and ASTM D523-89 (1999), ``Standard Test

Method for Specular Gloss,'' currently named ASTM Method D523-14
(2018), updated May 1, 2018.

IV. Summary of Impacts

    This section presents a summary of the impacts expected as a result
of this proposed rule.

A. Environmental Impacts

    There are no anticipated environmental impacts from compliance with
this proposed rule. The proposed revisions are minor and not expected
to result in net changes to an aerosol coating product's potential to
form ozone because the overall average changes to the values used to
measure reactivity, i.e., category emission limits and reactivity
factors, are small compared to the values in the original rule. The
proposed action is, however, expected to improve upon the original rule
by ensuring updates are made (e.g., adds new compounds, updates
reactivity factors, and adds electronic reporting) that promote
consistency and uniformity between state and national regulations. As
such, this proposed action would maintain the level of environmental
protection to populations in affected ozone nonattainment areas without
having any disproportionately high and adverse human health or
environmental effects on any populations, including any minority or
low-income populations.

B. Energy Impacts

    There are no adverse energy impacts anticipated from compliance
with this proposed rule.

C. Cost and Economic Impacts

    There are no adverse economic impacts anticipated from compliance
with this proposed rule. This action primarily updates reactivity
tables and factors and adds electronic reporting provisions.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' and was,
therefore, not submitted to OMB for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control number 2060-0617. There is no increase in burden associated
with this action because the rule primarily adds compounds and
reactivity factors, updates category limits and reactivity factors, and
adds electronic reporting provisions. The burden associated with the
proposed change from paper to electronic reporting would not change as
a result of this action, at least in the short term, because regulated
entities will need time to become familiar with the new reporting
scheme and template. In the long term, the Agency anticipates that
electronic reporting, which is more efficient than paper reporting,
would reduce the burden as regulated entities become more familiar with
the electronic reporting process. The EPA expects the decrease in
burden estimates resulting from electronic reporting would be reflected
in future updates to the ICR for this rule.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden or otherwise has a positive economic effect on the small
entities subject to the rule. This rule will not impose any
requirements on small entities. The EPA has determined that small
businesses will not incur any adverse impacts because the Agency is
taking this action to amend the aerosol coatings rule primarily by
updating coating categories in Table 1 and adding compounds to Table 2
of the rule and adding an electronic reporting provision. These
amendments do not create any new requirements or burdens, and no costs
are associated with these amendments. The Agency has, therefore,
concluded that this proposed rule will not pose any additional
regulatory burden for all affected small entities.
    The EPA continues to be interested in the potential impacts of the
proposed rule on small entities and welcome comments on issues related
to such impacts.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local or tribal governments or the
private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175 Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. The proposed regulatory action does not have a
substantial direct effect on one or more Indian tribes, in that this
action imposes no regulatory burdens on tribes. Thus, Executive Order
13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern increase in an
adverse or environmental health risk or safety risk that
disproportionately affects children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    The rule involves technical standards; however, no new technical
standards are being proposed in this action.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
Executive Order 12898 (59 FR 7629 (February 16, 1994)) establishes
federal executive policy on environmental justice.
    As stated in section VI of the preamble of this action, there are
no anticipated adverse environmental impacts and no adverse economic
impacts anticipated from compliance with this rule. As stated in
section I of this action, section 183(e) of the CAA requires the
control of VOC emissions from certain categories of consumer and
commercial products for purposes of reducing VOC emissions contributing
to ozone formation and nonattainment of the ozone NAAQS. The health and
environmental risks associated with ozone were considered in the
establishment of the ozone NAAQS. The level is designed to be
protective of the public with an adequate margin of safety.
Accordingly, these actions would help increase the level of
environmental protection to populations in affected ozone nonattainment
areas without having any disproportionately high and adverse human
health or environmental effects on any populations, including any
minority or low-income populations.

Michael S. Regan,
Administrator.
[FR Doc. 2021-19896 Filed 9-16-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48093-48095]
[FR Doc No: 2017-22288]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5928]

Post-Complete Response Letter Meetings Between the Food and Drug
Administration and Abbreviated New Drug Application Applicants Under
the Generic Drug User Fee Act; Draft Guidance for Industry;
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 draft guidance for industry entitled ``Post-
Complete Response Letter Meetings Between FDA and ANDA Applicants Under
GDUFA.'' This guidance is intended to clarify the criteria for granting
post-complete response letter (CRL) meeting requests and the scope of
discussions for granted meeting requests. This guidance provides
procedures that will promote well-managed post-CRL meetings and help
ensure that such meetings are scheduled and conducted in accordance
with the time frames set forth in the GDUFA Reauthorization Performance
Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals
or Commitment Letter).

DATES: Submit either electronic or written comments on the draft
guidance by December 15, 2017 to ensure that the Agency considers your
comment 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-2017-D-5928 for ``Post-Complete Response Letter Meetings Between
FDA and ANDA Applicants Under GDUFA; Draft Guidance for Industry;
Availability.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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 draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Tamara R. Coley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Building 75, Rm. 1668, Silver Spring, MD 20903, 240-
402-6903.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Post-Complete Response Letter Meetings Between FDA and ANDA
Applicants Under GDUFA.'' The Generic Drug User Fee Amendments of 2017
(GDUFA II), reauthorizing generic drug user fees for Fiscal Years 2018-
2022, was signed into law on August 18, 2017, to facilitate timely
access to quality, affordable generic medicines. In accordance with the
GDUFA II Commitment Letter \1\ that accompanied the legislation, FDA
agreed to certain review goals and procedures for the review of post-
CRL meetings received on or after October 1, 2017.
---------------------------------------------------------------------------

    \1\ Available at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf.
---------------------------------------------------------------------------

    The GDUFA II Commitment Letter adds time frames within which FDA
will provide a scheduled date for, and will conduct, post-CRL meetings.
Under GDUFA I, FDA committed to close out a certain number of
teleconference requests in fiscal year (FY) 2015 through FY 2017. In
accordance with the GDUFA II Commitment Letter, FDA committed to
schedule and conduct 90 percent of post-CRL meetings within prescribed
time frames.
    As described in the GDUFA II Commitment Letter, post-CRL meetings
will be used by applicants ``to seek clarification concerning
deficiencies identified in a CRL.'' Under GDUFA II, post-CRL meetings
are available for both major and minor CRLs and for first and
subsequent review cycles. FDA will grant any complete post-CRL meeting
request that satisfies the criteria outlined in section IV. FDA will
only grant post-CRL meeting requests that pose questions to clarify
identified deficiencies. Other issues, including questions requiring
further Agency review, disputes about classification of complete
response amendments, or new information submitted by the applicant,
will not be addressed in a post-CRL meeting.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Post-
Complete Response Letter Meetings Between FDA and ANDA Applicants Under
GDUFA.'' 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.

II. Paperwork Reduction Act of 1995

    This draft 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 314 have been approved under
OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: October 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22288 Filed 10-13-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Notices]
[Page 55711]
[FR Doc No: 2015-23191]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Request for Comments;
Revision of an Existing Information Collection: Medical Standards and
Certification

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and
Office of Management and Budget (OMB) regulations, the FAA invites
public comments about our intention to request OMB approval to revise
an existing information collection. The Federal Register Notice with a
60-day comment period soliciting comments on the following collection
of information was published on June 22, 2015. The information
collected is used to determine if applicants are medically qualified to
perform the duties associated with the class of airman medical
certificate sought. The FAA intends to revise the information it is
collecting via FAA form 8500-8, in part, to respond to recommendations
made in an April 2014 General Services Administration report entitled
``FAA Should Improve Usability of its Online Application System and
Clarity of the Pilot's Medical Form.'' This change will have a
negligible effect on the estimated time to complete form 8500-8.

DATES: Comments should be submitted by October 16, 2015.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW.,
Washington, DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    The FAA is seeking comments only with regard to the burden
associated with the information collection activity under OMB Control
Number 2120-0034. As such, any comments received that cite this notice
but are outside of the scope of the collection activity under OMB
Control Number 2120-0034 will not be addressed.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson at<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0034.
    Title: Medical Standards and Certification.
    Form Numbers: FAA forms 8500-7, 8500-8, and 8500-14.
    Type of Review: Revision of an existing information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on June 22, 2015 (80 FR 35695). The Secretary of
Transportation collects this information under the authority of 49
U.S.C. 40113; 44701; 44510; 44702; 44703; 44709; 45303; and 80111. The
airman medical certification program is implemented by Title 14 Code of
Federal Regulations (CFR) parts 61 and 67 (14 CFR parts 61 and 67). The
FAA determines if applicants are medically qualified to perform the
duties associated with the class of airman medical certificate sought.
    Respondents: Approximately 396,782 applicants for airman medical
certificates.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 1.5 hours.
    Estimated Total Annual Burden: 572,673 hours.

    Issued in Washington, DC on September 9, 2015.
Ronda Thompson,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, ASP-110.
[FR Doc. 2015-23191 Filed 9-15-15; 8:45 am]
BILLING CODE 4910-13-P