[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16199-16201]
[FR Doc No: 2022-06034]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0902]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medication Guides for Prescription Drug Products

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed revision of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with Medication Guides for prescription drug products.

DATES: Submit either electronic or written comments on the collection
of information by May 23, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 23, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include Docket No. FDA-
2011-N-0902 for ``Agency Information Collection Activities; Proposed
Collection; Comment Request; Medication Guide Requirements for
Prescription Drug Product Labeling.'' Received comments, those filed in
a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2(A) of the PRA (44 U.S.C. 3506(c)(2)(A)
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medication Guide Requirements for Prescription Drug Product Labeling

OMB Control Number 0910-0393--Extension

    This information collection supports FDA regulations pertaining to
the distribution of patient labeling, called Medication Guides, for
human prescription drug and biological products used primarily on an
outpatient basis, and required for products that pose a serious and
significant public health concern. Applicable regulations are codified
at 21 CFR part 208: Medication Guides for Prescription Drug Products,
and set forth general content and format requirements, as well as
provide for exemptions and deferrals. Medication Guides provide
patients with important written information about drug products,
including the drug's approved uses, contraindications, adverse drug
reactions, and cautions for specific populations, and are required in
accordance with Agency regulations.
    To assist consumers and industry with understanding applicable
regulatory requirements in 21 CFR part 208 pertaining to developing,
distributing, and submitting certain Medication Guides, we have
developed the guidance document entitled ``Medication Guides--
Distribution Requirements and Inclusion in Risk Evaluation and
Mitigation Strategies (REMS)'' (available at https://www.fda.gov/media/79776/download). The guidance document includes a discussion of the
applicable regulations; FDA enforcement policy with regard to
Medication Guides associated with products dispensed to healthcare
professionals, or patient caregivers, instead of being dispensed
directly to the patient for self-administration; and Medication Guides
required as part of a risk evaluation and mitigation strategy.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    Activity; 21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Content and format of a                       41               1              41             320          13,120
 Medication Guide; Sec.   208.20
Exemptions and deferrals; Sec.                 1               1               1               4               4
 208.26(a)......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............              42  ..............          13,124
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Upon evaluation of the information collection, we have removed
burden we attributed to reporting associated with supplements and other
changes to approved abbreviated new drug applications, new drug
applications, and biologics license applications (21 CFR
314.70(b)(3)(ii) and 601.12(f)). We now account for burden associated
with these regulatory provisions in OMB control numbers 0910-0001 and
0910-0338 and have decreased the burden associated with this collection
accordingly.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
           Activity; 21 CFR section               Number of    disclosures per   Total annual       Average burden per disclosure \2\       Total hours
                                                 respondents      respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Distribute Medication Guides to authorized                191            9,000       1,719,000  1.25....................................       2,148,750
 dispensers; Sec.   208.24(c).
Distribute and Dispense Medication Guides to           88,000            5,705     502,040,000  0.05 (3 minutes)........................      25,102,000
 Patients; Sec.   208.24(e).
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ...............     503,759,000  ........................................      27,250,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers may not sum due to rounding.

    We have decreased our estimated burden associated with disclosures
to reflect a decrease in related submissions over the past 3 years.

    Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06034 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Notices]
[Pages 52797-52798]
[FR Doc No: 2014-21084]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Agricultural
Aircraft Operator Certificate Application

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on June 12, 2014, vol. 79, no. 113, page 33797. Standards
have been established for the certification of agricultural aircraft.
The information collected shows applicant compliance and eligibility
for certification by FAA.

DATES: Written comments should be submitted by October 6, 2014.

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.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0049.
    Title: Agricultural Aircraft Operator Certificate Application.
    Form Numbers: FAA Form 8710-3.
    Type of Review: Renewal of an information collection.
    Background: 14 CFR part 137 prescribes requirements for issuing
agricultural aircraft operator certificates and for appropriate
operating rules. The information on FAA Form 8710-3, Agricultural
Aircraft Operator Certificate Application, is required from applicants
who wish to be issued a commercial or private agricultural aircraft
operator certificate. Aviation Safety Inspectors in FAA Flight
Standards District Offices (FSDO) review the submitted information to
determine certificate eligibility.
    Respondents: Approximately 2,950 applicants.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 1.3 hours.
    Estimated Total Annual Burden: 10,275 hours.
    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.

     Issued in Washington, DC, on August 28, 2014.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, ASP-110.
[FR Doc. 2014-21084 Filed 9-3-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 10, 2008 (Volume 73, Number 112)]
[Notices]
[Page 32701]
[DOCID:fr10jn08-33]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER98-1466-005; ER00-814-006; ER00-2924-006; ER02-1638-005]

Allegheny Power; Allegheny Energy Supply Company, LLC; Green
Valley Hydro, LLC; Buchanan Generation, LLC; Notice of Filing

June 3, 2008.
    Take notice that on April 30, 2008, Allegheny Energy Supply
Company, LLC, Green Valley Hydro, LLC and Buchanan Generation, LLC
filed revised market-based rate tariffs to their triennial market power
analysis filed with the Commission on January 14, 2008 and supplemented
on April 21, 2008.
    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, 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 on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    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>.
    Comment Date: 5 p.m. Eastern Time on June 13, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-12937 Filed 6-9-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Pages 19552-19555]
[FR Doc No: 2013-07414]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69235; File No. SR-CBOE-2013-036]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Order Type and Auction Rules in Advance
of Mini-Option Launch

March 25, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 20, 2013, the Chicago Board Options Exchange,
Incorporated (the ``Exchange'' or ``CBOE'') filed with the Securities
and Exchange Commission (the ``Commission'') the proposed rule change
as described in Items I and II below, which Items have been prepared by
the Exchange. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to amend Rules 6.53 (Certain Types of Orders
Defined), 6.74 (Crossing Orders), 6.74A (Automated Improvement
Mechanism (``AIM'')) and 6.74B (Solicitation Auction Mechanism). Each
of these rules sets forth minimum order quantities predicated on an
option contract delivering 100 shares. The proposal would amend these
rules to maintain the same minimum order quantities in amounts
proportional to mini-options delivering 10 shares (i.e., the same
number of underlying securities). The Exchange is not proposing to
change the substantive content of these rules. The text of the proposed
rule change is available on the Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's
Office of the Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    CBOE recently amended its rules to allow for the listing of mini-
options that deliver 10 physical shares on SPDR S&P 500 (``SPY''),
Apple, Inc. (``AAPL''), SPDR Gold Trust (``GLD''), Google Inc.
(``GOOG'') and Amazon.com Inc. (``AMZN'').\5\ Mini-options trading is
expected to commence on March 18, 2013.
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    \5\ See Securities Exchange Act Release No. 68656 (January 15,
2013), 78 FR 4526 (January 22, 2013) (Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change to List and Trade Option
Contracts Overlying 10 Shares of Certain Securities) (SR-CBOE-2013-
001). See also CBOE Rule 5.5.22.
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    Standard equity and exchange-traded fund (``ETF'') option contracts
have a unit of trading of 100 shares deliverable and mini-options will
have a unit of trading of 10 shares deliverable.\6\ Except for the
difference in the number of deliverable shares, mini-options will have
the same terms and contract characteristics as standard equity and ETF
options, including exercise style. Accordingly, the Exchange
represented in its original mini-option filing that Exchange rules that
apply to the trading of standard option contracts will apply to mini-
options as well.\7\
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    \6\ Strike prices for mini-options will be set at the same level
as for standard options. See CBOE Rule 5.5.22(b). Bids and offers
for mini-options will be expressed in terms of dollars per 1/10th
part of the total value of the contract. See CBOE Rule 6.41(c). No
additional series of mini-options may be added if the underlying
security is trading at $90 or less. The underlying security must
trade above $90 for five consecutive days prior to listing mini-
option contracts in an additional expiration month. See CBOE Rule
5.5.22(c).
    \7\ 78 FR 4527.
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    Prior to the commencement of trading mini-options, the Exchange
proposes to amend Rules 6.53 (Certain Types of Orders Define), 6.74
(Crossing Orders), 6.74A (AIM) and 6.74B (Solicitation Auction
Mechanism). Each of these rules sets forth minimum order quantities
predicated on an option contract delivering 100 shares. The purpose of
the proposed rule change is to amend these rules to maintain the same
minimum order quantities in amounts proportional to mini-options
delivering 10 shares (i.e., the same number of underlying securities).
The Exchange is not proposing to change the substantive content of
these rules.
CBOE Rule 6.53(u): Certain Types of Orders Defined--Qualified
Contingent Crosses (``QCC'')
    CBOE Rule 6.53 sets forth different order types that may be made
available on a class-by-class basis for trading on the Exchange.
Subparagraph (u) to CBOE Rule 6.53 provides for the availability of QCC
orders, which are orders to buy (sell) at least 1,000 standard options
that are identified as being a part of a qualified contingent trade
coupled with a contra-side order to buy (sell) an equal number of
contracts.
    A controversial feature of QCC orders is that they ``may execute
without exposure provided the execution (1) is not at the same price as
a public customer order resting in the electronic book and (2) is at or
between the [National Best Bid or Offer]''.\8\ The Commission approved
the availability of QCC orders in which the order has a minimum size of
1,000 standard option contracts (which is equivalent to 10,000 mini-
option contracts). Because QCC orders may be executed without exposure,
the Exchange believes that it is imperative to maintain the minimum QCC
order size for mini-options that is required for standard options in
proportion.
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    \8\ See CBOE Rule 6.53(u)(ii). CBOE commented extensively when
QCC orders were initially proposed by the International Securities
Exchange, LLC (``ISE'') and a protracted regulatory review of QCC
orders culminated with the Commission approving the introduction of
QCC orders, notwithstanding CBOE's strong objections to the order
type. See Exchange Act Release No. 63955 (February 24, 2011), 76 FR
11533 (March 2, 2011) (SR-ISE-2010-73). CBOE adopted rules to permit
QCC orders as a competitive response but continues to remain
critical of the order type. See Exchange Act Release No. 64653 (June
13, 2011), 76 FR 35491 (June 17, 2011) (SR-CBOE-2011-041).
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    Accordingly, CBOE proposes to amend CBOE Rule 6.53(u) to specify
that the minimum QCC order size for standard options is 1,000 contracts
and the minimum order size for mini-

options is 10,000 contracts. Contra-side orders to sell (buy) must
contain an equal number of contracts that are comprised exclusively of
the same option type (i.e., all standard options or all mini-options).
CBOE Rule 6.74: Crossing Orders, SizeQuote Mechanism and Tied Hedges
    CBOE Rule 6.74 sets forth rules of priority and order allocation
procedures that apply to crossing orders in open outcry. Subparagraph
(d) to Rule 6.74 provides that Floor Brokers may cross a certain
percentage of a public customer order with a facilitation order of the
originating firm (i.e., the firm from which the original customer order
originated). That provision further provides that the Exchange may
determine to include solicited orders within the provision of the rule
and may determine (on a class-by-class basis) the eligible size for an
order that may be transacted under subparagraph (d), however, the
eligible order size may not be less than 50 standard option contracts
(which is equivalent to 500 mini-option contracts). The Exchange
proposes to maintain the minimum eligible order size for mini-options
that is required for standard options in proportion.
    Accordingly, CBOE proposes to amend CBOE Rule 6.74(d) to specify
that the minimum crossing order size for standard options may not be
less than 50 contracts and the minimum crossing order size for mini-
options may not be less than 500 contracts.
    CBOE Rule 6.74(f) sets forth rules regarding the Open Outcry
``SizeQuote Mechanism,'' which is a process by which a Floor Broker may
execute and facilitate large-size orders in open outcry. The eligible
order size may not be less than 250 standard option contracts (which is
equivalent to 2,500 mini-option contracts). The Exchange proposes to
maintain the minimum eligible order size for mini-options that is
required for standard options in proportion.
    Accordingly, CBOE proposes to amend CBOE Rule 6.74(f)(i)(A) to
specify that the minimum order size for standard options may not be
less than 250 contracts and the minimum order size for mini-options may
not be less than 2,500 contracts.
    The Exchange proposes to make a technical, non-substantive change
to CBOE Rule 6.74(f)(i) to delete obsolete rule text that references a
pilot program that expired on February 15, 2008.
    CBOE Rule 6.74.10 provides that Rule 6.9 (Solicited Transactions)
does not prohibit a Trading Permit Holder (``TPH'') or TPH organization
from buying or selling a stock, security futures or futures position
following receipt of an option order, including a complex order. Prior
to announcing such an order to the trading crowd, the option order must
be in a class that has been designated eligible for ``tied hedge''
transactions and must be within the designated tied hedge eligibility
size parameters, which are established by CBOE on class-by-class basis
and which may not be smaller than 500 standard option contracts per
order (which is equivalent to 5,000 mini-option contracts). Multiple
orders may not be aggregated to satisfy the size parameter. The
Exchange proposes to maintain the minimum designated tied hedge
eligibility size parameters for mini-options that are required for
standard options in proportion.
    Accordingly, CBOE proposes to amend CBOE Rule 6.74.10 to specify
that the minimum order size for standard options may not be smaller
than 500 contracts and the minimum order size for mini-options may not
be smaller than 5,000 contracts.
CBOE Rule 6.74A: AIM
    CBOE Rule 6.74A permits a TPH that represents agency orders to
electronically execute an order it represents as an agent (``Agency
Order'') against principal interest or against a solicited order
provided it submits the Agency Order for electronic execution into the
AIM auction pursuant to the requirements of CBOE Rule 6.74A. CBOE Rule
6.74A sets forth minimum size requirements for initiating auctions.
Specifically, CBOE Rule 6.74A(a)(1) and (2) provide:
     if the Agency Order is for 50 standard option contracts
(which is equivalent to 500 mini-option contracts) or more, the
Initiating Trading Permit Holder must stop the entire Agency Order as
principal or with a solicited order at the better of the NBBO or the
Agency Order's limit price (if the order is a limit order); and
     if the Agency Order is for less than 50 option standard
contracts (which is equivalent to 500 mini-option contracts), the
Initiating Trading Permit Holder must stop the entire Agency Order as
principal or with a solicited order at the better of (A) the NBBO price
improved by one minimum price improvement increment, which increment
shall be determined by the Exchange but may not be smaller than one
cent; or (B) the Agency Order's limit price (if the order is a limit
order).
    Similarly, CBOE Rule 6.74A(b)(1)(A) sets forth provisions governing
the auction period and request for responses (``RFRs''). CBOE Rule
6.74A(b)(1)(A) sets forth order procedures for automatic matching based
on size that provide:
     the Agency Order will be stopped at the NBBO (if 50
standard contracts or greater (which is equivalent to 500 mini-option
contracts)), or
     one cent/one minimum increment better than the NBBO (if
less than 50 contracts (which is equivalent to 500 mini-option
contracts)).
    The Exchange proposes to maintain the order sizes for mini-options
that are required for standard options in proportion.
    Accordingly, CBOE proposes to amend CBOE Rule 6.74A(a)(2) and (3)
and 6.74A(b)(1)(A) to specify that order size for standard options is
50 contracts and the order size for mini-options is 500 contracts.
CBOE Rule 6.74B: Solicitation Auction Mechanism
    CBOE Rule 6.74B permits a TPH that represents agency orders to
electronically execute orders it represents as agent (``Agency Order'')
against solicited orders provided it submits the Agency Order for
electronic execution into the solicitation auction mechanism (the
``Auction'') pursuant to the requirements of CBOE Rule 6.74B. CBOE Rule
6.74B requires the Exchange to determine minimum eligible size
parameters for participation in Auctions, however, the eligible order
size may not be less than 500 standard option contracts (which is
equivalent to 5,000 mini-option contracts). The Exchange proposes to
maintain the minimum eligibility size parameters for mini-options that
are required for standard options in proportion.
    Accordingly, CBOE proposes to amend CBOE Rule 6.74B(a)(1) to
specify that the minimum order size for standard options may not be
less than 500 contracts and the minimum order size for mini-option may
not be less than 5,000 contracts.
    Standard option series subject to an adjustment will be subject to
the minimum order quantities for standard options contained in the CBOE
Rules addressed by this filing and mini-option series subject to an
adjustment will be subject to the minimum order quantities for mini-
options contained in the CBOE Rules addressed by this filing.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder, including the
requirements

of Section 6(b) of the Act.\9\ In particular, the Exchange believes the
proposed rule change is consistent with the Section 6(b)(5) \10\
requirements that the rules of an exchange be designed to promote just
and equitable principles of trade, to prevent fraudulent and
manipulative acts, to foster cooperation and coordination with persons
engaged in facilitating transactions in securities, to remove
impediments to and to perfect the mechanism for a free and open market
and a national market system, and, in general, to protect investors and
the public interest.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Specifically, the Exchange believes that investors would benefit
from the current rule proposal because it would clarify how minimum
order quantities that are predicated on an option contract delivering
100 shares will apply to mini-options. The Exchange believes that the
marketplace and investors will be expecting clarification by the
Exchange on this issue. As a result, the Exchange believes that this
change would lessen investor and marketplace confusion because the
rules being amended by this filing will be clear as to the application
to mini-options.
    The Exchange also believes that the current proposal is designed to
promote just and equitable principles of trade because it will maintain
the same minimum order quantities in amounts proportional to mini-
options.

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

    This proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. In this regard, since mini-options are permitted on multiply-
listed classes, the Exchange understands and expects similar rule
filings will be submitted by other exchanges to similarly change any
order type and auction rules so that their rules that set forth minimum
order quantities for standard options will apply in amounts
proportional to mini-options. CBOE also believes that the proposed rule
change will enhance competition by providing for the same proportional
minimum order quantities contained in order type and auction rules to
apply to standard and mini-options on the same security.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms does not become operative for 30 days after the
date of this filing, or such shorter time as the Commission may
designate if consistent with the protection of investors and the public
interest, the proposed rule change has become effective pursuant to
Section 19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(6)
thereunder.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide the Commission
with written notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Exchange has fulfilled this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange requests that the Commission waive
the 30-day operative delay so that the proposed rule change may
coincide with the anticipated launch of trading in Mini Options. The
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public
interest.\13\ Waiver of the operative delay will allow the Exchange to
implement its proposal consistent with the commencement of trading in
Mini Options as scheduled and expected by members and other
participants on March 18, 2013. For these reasons, the Commission
designates the proposed rule change as operative upon filing.
---------------------------------------------------------------------------

    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2013-036 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2013-036. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2013-036 and should be
submitted on or before April 22, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-07414 Filed 3-29-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Page 30934]
[FR Doc No: 2022-10920]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP22-925-000.
    Applicants: Washington 10 Storage Corporation.
    Description: Compliance filing: FERC Form No. 2-A Page 520
Compliance Filing.
    Filed Date: 5/13/22.
    Accession Number: 20220513-5111.
    Comment Date: 5 p.m. ET 5/25/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP21-543-000.
    Applicants: Northwest Pipeline LLC.
    Description: Report Filing: TPAL Activity Report to be effective N/
A.
    Filed Date: 5/13/22.
    Accession Number: 20220513-5081.
    Comment Date: 5 p.m. ET 5/25/22.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 16, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-10920 Filed 5-19-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 25, 2007 (Volume 72, Number 142)]
[Rules and Regulations]
[Page 40746-40749]
[DOCID:fr25jy07-7]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R03-OAR-2007-0174; FRL-8445-6]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Attainment Determination, Redesignation of the Franklin
County Ozone Nonattainment Area to Attainment and Approval of the
Area's Maintenance Plan and 2002 Base-Year Inventory

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving a redesignation request and State
Implementation Plan (SIP) revisions submitted by the Commonwealth of
Pennsylvania. The Pennsylvania Department of Environmental Protection
(PADEP) is requesting that the Franklin County nonattainment area
(``Franklin County Area'' or ``Area'') be redesignated as attainment
for the 8-hour ozone national ambient air quality standard (NAAQS). In
conjunction with its redesignation request, the PADEP submitted SIP
revisions consisting of a maintenance plan for the Franklin County Area
that provides for continued attainment of the 8-hour ozone NAAQS for at
least 10 years after redesignation. EPA is approving the 8-hour
maintenance plan. PADEP also submitted a 2002 base-year inventory for
the Franklin County Area which EPA is approving. In addition, EPA is
approving the adequacy determination for the motor vehicle emission
budgets (MVEBs) that are identified in the Franklin County Area
maintenance plan for purposes of transportation conformity, and is
approving those MVEBs. EPA is approving the redesignation request, and
the maintenance plan, and the 2002 base-year emissions inventory as
revisions to the Pennsylvania SIP in accordance with the requirements
of the Clean Air Act (CAA).

DATES: Effective Date: This final rule is effective on July 25, 2007
pursuant to the authority of 5 U.S.C. 553(d)(1).

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2007-0174. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the

electronic docket, some information is not publicly available, i.e.,
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http://www.regulations.gov
 or in hard copy for public inspection during normal

business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103. Copies of the State submittal are available at the
Pennsylvania Department of Environmental Protection, Bureau of Air
Quality Control, P.O. Box 8468, 400 Market Street, Harrisburg,
Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Christopher Cripps,<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On May 30, 2007 (72 FR 29914), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Pennsylvania. The NPR proposed
approval of Pennsylvania's redesignation request, a SIP revision that
establishes a maintenance plan for the Franklin County Area that
provides for continued attainment of the 8-hour ozone NAAQS for at
least 10 years after redesignation, and a 2002 base-year emissions
inventory. The formal SIP revisions were submitted by PADEP on December
14, 2006. Other specific requirements of Pennsylvania's redesignation
request and SIP revision for the maintenance plan, and the rationale
for EPA's proposed actions are explained in the NPR and will not be
restated here. No public comments were received on the NPR.
    On December 22, 2006, the U.S. Court of Appeals for the District of
Columbia Circuit vacated EPA's Phase 1 Implementation Rule for the 8-
hour Ozone Standard. (69 FR 23951, April 30, 2004). South Coast Air
Quality Management Dist. v. EPA, 472 F.3d 882 (DC Cir. 2006). On June
8, 2007, in South Coast Air Quality Management Dist. v. EPA, Docket No.
04-1201, in response to several petitions for rehearing, the DC Circuit
clarified that the Phase 1 Rule was vacated only with regard to those
parts of the rule that had been successfully challenged. Therefore, the
Phase 1 Rule provisions related to classifications for areas currently
classified under subpart 2 of Title I, part D of the Act as 8-hour
nonattainment areas, the 8-hour attainment dates, and the timing for
emissions reductions needed for attainment of the 8-hour

ozone NAAQS remain effective. The June 8 decision left intact the
Court's rejection of EPA's reasons for implementing the 8-hour standard
in certain nonattainment areas under subpart 1 in lieu of subpart 2. By
limiting the vacatur, the Court let stand EPA's revocation of the 1-
hour standard and those anti-backsliding provisions of the Phase 1 Rule
that had not been successfully challenged. The June 8 decision
reaffirmed the December 22, 2006 decision that EPA had improperly
failed to retain four measures required for 1-hour nonattainment areas
under the anti-backsliding provisions of the regulations: (1)
Nonattainment area nonattainment New Source Review (NSR) requirements
based on an area's 1-hour nonattainment classification; (2) Section 185
penalty fees for 1-hour severe or extreme nonattainment areas; and (3)
measures to be implemented pursuant to section 172(c)(9) or 182(c)(9)
of the Act, on the contingency of an area not making reasonable further
progress toward attainment of the 1-hour NAAQS, or for failure to
attain that NAAQS. In addition the June 8 decision clarified that the
Court's reference to conformity requirements for anti-backsliding
purposes was limited to requiring the continued use of 1-hour motor
vehicle emissions budgets until 8-hour budgets were available for 8-
hour conformity determinations, which is already required under EPA's
conformity regulations. The Court thus clarified that 1-hour conformity
determinations are not required for anti-backsliding purposes.
    For the reasons set forth in the May 30, 2007 (72 FR 29914)
proposed rulemaking, EPA does not believe that the Court's rulings
alter any requirements relevant to this redesignation action so as to
preclude redesignation, and do not prevent EPA from finalizing this
redesignation. EPA believes that the Court's December 22, 2006 and June
8, 2007 decisions impose no impediment to moving forward with the
redesignation of the Franklin County Area to attainment, because even
in light of the Court's decisions, redesignation is appropriate under
the relevant redesignation provisions of the Act and longstanding
policies regarding redesignation requests.
    In the May 30, 2007 (72 FR 29914) proposed rulemaking, EPA proposed
to find that the Franklin County Area had satisfied the requirements
under the 1-hour standard whether the 1-hour standard was deemed to be
reinstated or whether the Court's decision on the petition for
rehearing was modified to require something less than compliance with
all applicable 1-hour requirements. Because EPA proposed to find that
the Franklin County Area satisfied the requirements under either
scenario, EPA is proceeding to finalize the redesignation and to
conclude that the Franklin County Area met the requirements under the
1-hour standard applicable for purposes of redesignation under the 8-
hour standard. These include the provisions of EPA's anti-backsliding
rules, as well as the additional anti-backsliding provisions identified
by the court in its rulings. In its June 8, 2007 decision the Court
limited its vacatur so as to uphold those provisions of the anti-
backsliding requirements that were not successfully challenged.
Therefore, EPA finds that the Franklin County Area has met the anti-
backsliding requirements, see 40 CFR 51.900 et seq.; 70 FR 30592, 30604
(May 26, 2005), which apply by virtue of the Franklin County Area's
classification for the 1-hour ozone NAAQS, as well as the four
additional anti-backsliding provisions identified by the Court, or
alternatively, that such requirements are not applicable for purposes
of redesignation. In addition, with respect to the requirement for
transportation conformity under the 1-hour standard, the Court in its
June 8 decision clarified that for those areas with 1-hour motor
vehicle emissions budgets, anti-backsliding requires only that those 1-
hour budgets must be used for 8-hour conformity determinations until
replaced by 8-hour budgets. To meet this requirement, conformity
determinations in such areas must continue to comply with the
applicable requirements of EPA's conformity regulations at 40 CFR Part
93. The court clarified that 1-hour conformity determinations are not
required for anti-backsliding purposes.

II. Final Actions

    EPA is approving the Commonwealth of Pennsylvania's redesignation
request, maintenance plan, and the 2002 base-year emissions inventory
because the requirements for approval have been satisfied. EPA has
evaluated Pennsylvania's redesignation request that was submitted on
December 14, 2006, and determined that it meets the redesignation
criteria set forth in section 107(d)(3)(E) of the CAA. EPA believes
that the redesignation request and monitoring data demonstrate that the
Franklin County Area has attained the 8-hour ozone standard. The final
approval of this redesignation request will change the designation of
the Franklin County Area from nonattainment to attainment for the 8-
hour ozone standard. EPA is approving the maintenance plan for the
Franklin County Area submitted on December 14, 2006 as a revision to
the Pennsylvania SIP. EPA is also approving the MVEBs submitted by
PADEP in conjunction with its redesignation request. In addition, EPA
is approving the 2002 base-year emissions inventory submitted by PADEP
on December 14, 2006 as a revision to the Pennsylvania SIP. In this
final rulemaking, EPA is notifying the public that we have found that
the MVEBs for nitrogen oxides (NOX) and volatile organic
compounds (VOCs) in the Franklin County Area for the 8-hour ozone
maintenance plan are adequate and approved for conformity purposes. As
a result of our finding, the Franklin County Area must use the MVEBs
from the submitted 8-hour ozone maintenance plan for future conformity
determinations. The adequate and approved MVEBs are provided in the
following table:

  Adequate and Approved Motor Vehicle Emissions Budgets in Tons per Day
               (TPD)--Rounded Upward to One Decimal Place
------------------------------------------------------------------------
                      Budget year                         NOX      VOC
------------------------------------------------------------------------
2009..................................................     12.7      7.3
2018..................................................      6.7      5.1
------------------------------------------------------------------------

    With respect to the 1-hour ozone NAAQS, EPA has determined pursuant
to section 181(b)(2) of the CAA that the Franklin County Area has
attained the 1-hour NAAQS for ozone. On the basis of this
determination, EPA is also determining that the following nonattainment
area requirements of part D to Title 1 of the CAA are not applicable to
the Franklin County Area for so long as it continues to attain the 1-
hour NAAQS for ozone: The requirements of section 172(c)(1) concerning
the submission of the ozone attainment demonstration and reasonably
available control measure requirements, the requirements of section
172(c)(2) concerning reasonable further progress (RFP), and the
requirements of section 172(c)(9) concerning contingency measures for
RFP or attainment. If a violation of the 1-hour ozone NAAQS is
monitored in the Franklin County 1-hour ozone nonattainment area, these
determinations shall no longer apply.

III. Statutory and Executive Order Reviews

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the

Office of Management and Budget. For this reason, this action is also
not subject to Executive Order 13211, ``Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001). This action merely approves state law as meeting
Federal requirements and imposes no additional requirements beyond
those imposed by state law. Redesignation of an area to attainment
under section 107(d)(3)(e) of the Clean Air Act does not impose any new
requirements on small entities. Redesignation is an action that affects
the status of a geographical area and does not impose any new
regulatory requirements on sources. Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing
requirements under state law and does not impose any additional
enforceable duty beyond that required by state law, it does not contain
any unfunded mandate or significantly or uniquely affect small
governments, as described in the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). This rule also does not have tribal implications
because it will not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000). Because this
action affects the status of a geographical area, does not impose any
new requirements on sources, or allows the state to avoid adopting or
implementing other requirements, this action also does not have
Federalism implications because it does 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, as specified
in Executive Order 13132 (64 FR 43255, August 10, 1999). This action
merely approves a state rule implementing a Federal requirement, and
does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. This rule also is
not subject to Executive Order 13045 ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997), because it approves a state rule implementing a Federal
standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Redesignation is an
action that affects the status of a geographical area and does not
impose any new requirements on sources. Thus, the requirements of
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 24, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.
    This action, approving the redesignation of the Franklin County
Area to attainment for the 8-hour ozone NAAQS, the associated
maintenance plan, the 2002 base-year emissions inventory, and the MVEBs
identified in the maintenance plan, may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: July 18, 2007.
James W. Newsom,
Acting Regional Administrator, Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by adding
an entry for the 8-hour Ozone Maintenance Plan and the 2002 Base Year
Emissions Inventory for the Franklin County, Pennsylvania Area at the
end of the table to read as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

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

                                                  * * * * * * *
8-Hour Ozone Maintenance Plan and  Franklin County Area        9/20/06,  7/25/07 [Insert
 2002 Base Year Emissions           (Franklin County).         11/08/06   page number where
 Inventory.                                                               the document
                                                                          begins].
----------------------------------------------------------------------------------------------------------------

0
3. Section 52.2037 is amended by adding paragraph (m) to read:

Sec.  52.2037  Control strategy plans for attainment and rate-of-
progress: Ozone.

* * * * *
    (m) Determination--EPA has determined that, as of July 25, 2007,
the Franklin County ozone nonattainment area has attained the 1-hour
ozone standard and that the following requirements of section 172(c)(2)
of the Clean Air Act do not apply to this area for so long as the area
does not monitor any violations of the 1-hour ozone standard of 40 CFR
50.9: the attainment demonstration and reasonably available control
measure requirements of section 172(b)(1), the reasonable further
progress requirement of section 172(b)(2), and the related contingency
requirements of section 172(c)(9). If a violation of the 1-hour ozone
NAAQS is monitored in the Franklin County 1-hour ozone nonattainment
area, these determinations shall no longer apply.

PART 81--[AMENDED]

0
4. The authority citation for part 81 continues to read as follows:

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

0
5. In Sec.  81.339, the table entitled ``Pennsylvania-Ozone (8-Hour
Standard)'' is amended by revising the entry for the Franklin County,
PA Area to read as follows:

Sec.  81.339  Pennsylvania

* * * * *

                                                          Pennsylvania--Ozone (8-Hour Standard)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Designation \a\                                           Category/classification
       Designated area        --------------------------------------------------------------------------------------------------------------------------
                                                Date \1\                               Type                     Date \1\                   Type
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Franklin Co., PA:
    Franklin County..........  July 25, 2007.............................  Attainment.................

                                                                     * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Includes Indian County located in each county or area, except otherwise noted.
\1\ This date is June 15, 2004, unless otherwise noted.

* * * * *
[FR Doc. 07-3631 Filed 7-24-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: June 30, 2008 (Volume 73, Number 126)]
[Notices]
[Page 36862]
[DOCID:fr30jn08-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-424-000]

Colorado Interstate Gas Company; Notice of Request Under Blanket
Authorization

June 23, 2008.
    Take notice that on June 17, 2008, Colorado Interstate Gas Company
(CIG), Post Office Box 1087, Colorado Springs, Colorado 80944, filed in
Docket No. CP08-424-000, a prior notice request pursuant to sections
157.205(b) and 157.216(b) of the Federal Energy Regulatory Commission's
regulations under the Natural Gas Act for authorization to abandon in
place a 4.7-mile segment of 22-inch outer diameter pipe on its Wyoming
Mainline (Line No. 5A) located in Adams and Denver Counties, Colorado,
all as more fully set forth in the application, which is on file with
the Commission and open to public inspection. The filing may also be
viewed on the Web at http://www.ferc.gov using the ``eLibrary'' link.
Enter the docket number excluding the last three digits in the docket
number field to access the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    CIG proposes to abandon in place a 4.7-mile segment of Line No. 5A.
CIG asserts that this segment has not provided natural gas service for
several years. CIG states that this segment is located in an area with
increasing right-of-way encroachment, which requires increased
monitoring, making this segment operationally undesirable. CIG asserts
that the ongoing monitoring, operation, and maintenance (O&M)
activities on the 4.7-mile segment of Line No. 5A cost CIG
approximately $12,000 annually. CIG states that the proposed
abandonment will have no operational impacts on CIG, nor will it
adversely affect CIG's ability to meet any of its existing contractual
obligations. CIG avers that the abandonment of the 4.7-mile segment of
Line No. 5A will not impact the available capacity for CIG's Wyoming
Mainline or its overall system capacity.
    Any questions regarding the application should be directed to
Richard Derryberry, Director, Regulatory Affairs Department, Colorado
Interstate Gas Company, Post Office Box 1087, Colorado Springs,
Colorado 80904, or<PHONE_NUMBER>.
    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff,
may, pursuant to section 157.205 of the Commission's Regulations under
the Natural Gas Act (NGA) (18 CFR 157.205) file a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for protest. If a protest is filed and not
withdrawn within 30 days after the time allowed for filing a protest,
the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.
    Comment Date: August 25, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-14682 Filed 6-27-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: August 26, 2010 (Volume 75, Number 165)]
[Notices]
[Page 52593]
[DOCID:fr26au10-117]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2010-39]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petitions or their final disposition.

DATES: Comments on these petitions must identify the petition docket
number involved and must be received on or before September 15, 2010.

ADDRESSES: You may send comments identified by Docket Number FAA-2010-
0751 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Tyneka L. Thomas,<PHONE_NUMBER>, or
Ralen Gao,<PHONE_NUMBER>, Office of Rulemaking, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on August 23, 2010.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2010-0751.
    Petitioner: JetBlue Airways Corporation.
    Section of 14 CFR Affected: Sec.  119.3.

Description of Relief Sought

    JetBlue Airways Corporation (JetBlue) requests relief from Sec.
119.3 to permit JetBlue to operate flights between Puerto Rico and the
Dominican Republic under the rules applicable to domestic operations.

[FR Doc. 2010-21238 Filed 8-25-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Notices]
[Pages 5813-5815]
[FR Doc No: 2012-2583]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0057]

Cardiovascular Metallic Implants: Corrosion, Surface
Characterization, and Nickel Leaching; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Cardiovascular Metallic Implants: Corrosion,
Surface Characterization, and Nickel Leaching.'' The purpose of this
public workshop is to provide a forum for FDA, cardiovascular device
manufacturers, test houses, and academia to discuss corrosion, surface
characterization, and nickel leach testing, as well as to collect
comments and input regarding when these assessments should be
considered.
    Dates and Time: The public workshop will be held on March 8 and 9,
2012, from 9 a.m. to 5:30 p.m. EST.
    Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503 (the Great Room),
Silver Spring, MD 20993. For parking and security information, please
visit the following Web site: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The
public workshop will also be available to be viewed online via webcast.
    Contact Persons:

Erica Takai, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993,
(301) 796-6353, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or
Nicole Ibrahim, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993,
(301) 796-5171, email<EMAIL_ADDRESS>
    Registration: To register for the public workshop, please visit the
following Web site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to http://www.fda.gov and
select the FDA Medical Devices News & Events--Workshops & Conferences
calendar and select this public workshop from the posted events list).
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number. For those without Internet access, please call the Contact
Person to register. Registration is mandatory as space is limited and
onsite registration will not be available. FDA may limit the number of
participants from each organization. There is no registration fee for
the public workshop. Registration requests should be received by 5 p.m.
E.S.T. on February 21, 2012.
    If you need special accommodations due to a disability, please
contact Susan Monahan, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4321, Silver Spring, MD 20993, (301) 796-
5661 or email<EMAIL_ADDRESS>at least 7 days in advance of
the workshop.
    Streaming Webcast of the Public Workshop: This workshop will also
be webcast. Persons interested in viewing the webcast must register
online by 5 p.m. E.S.T. on February 21, 2012. Early registration is
recommended because webcast connections are limited. Organizations are
requested to register all participants, but view using one connection
per location. Webcast participants will be sent technical system
requirements after registration, and will be sent connection access
information in a final confirmation email by 5 p.m. E.S.T. on March 2,
2012. If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit http://www.adobe.com/go/connectpro_overview. (FDA has verified
the Web site addresses in this document, but FDA is not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register).
    Workshop Participation: Participation in the workshop will consist
of both lead participants and audience members. Lead participants will
include representatives from various organizations involved in or who
perform corrosion testing, surface characterization, and/or nickel
leach testing and toxicological assessments of nickel, such as
industry, the medical community, and test houses, and will be driving
the discussions. Lead participants are expected to complete a work
assignment in advance of the workshop in order to optimize the time
spent during the workshop. FDA will compile the work assignment
responses prior to the workshop so that any information provided from
the responding organization is de-identified.
    If you wish to participate as a lead participant, you must indicate
this at the time of registration. There will be a tentative limit of
one lead participant per organization for industry and two for test
houses for each session, with a total workshop participation limit of
two industry participants and three for test houses, due to space
limitations. Audience members may be able to participate in
discussions, if time permits.
    Additional Information: Background information on the public
workshop, registration information, agenda, information about lodging,
food services, and other relevant information will be posted, as it
becomes available, on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to
http://www.fda.gov and select the FDA Medical Devices News & Events--
Workshops and Conferences calendar and select this public workshop from
the posted events list).
    Comments: FDA is holding this public workshop to obtain information
on a number of questions regarding corrosion, surface characterization,
and nickel leaching. In order to permit the widest possible opportunity
to obtain public comment, FDA is soliciting written or electronic
comments on all aspects of the workshop topics. The deadline for
submitting comments related to this public workshop is April 6, 2012.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic or written comments. Submit electronic
comments to http://www.regulations.gov. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. In addition, when
responding to specific topics as outlined in section II of this
document, please identify the topic you are addressing. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday and will be posted to the docket
at http://www.regulations.gov.

SUPPLEMENTARY INFORMATION:

I. Background and Objectives

    While the majority of cardiovascular implants are made of metals
and may be susceptible to corrosion, it is unclear whether the current
corrosion testing paradigm is predictive of in vivo corrosion outcomes,
or if there may be more suitable assessments to predict corrosion
failure. In addition, there has been an increase in the use of nitinol,
a nickel-titanium alloy, in cardiovascular implants due to its
superelastic properties, which are ideal for transcatheter-delivered
therapies. Corrosion of implant devices made of nitinol and other
nickel-containing metal alloys (e.g. stainless steel, MP35N) results in
the release of nickel ions,

which may lead to various modes of toxicities. Furthermore, both nickel
ion release and corrosion characteristics are dependent on surface
finishing for nitinol as well as for some other nickel-containing
alloys. Through the collection of information from a pre-workshop work
assignment and discussions with workshop participants, FDA will be able
to better determine what assessments may be considered for
cardiovascular implants made of commonly used metallic alloys, and this
information is expected to serve as the foundation for a future
guidance document.

II. Topics for Discussion at the Public Workshop

    The objective of this workshop is to provide a forum for discussion
of the following topics:
     The various methods that are used for corrosion
assessments, surface characterization techniques, and nickel leach
testing used to evaluate the suitability of metallic cardiovascular
implant devices;
     The limitations of each of these tests to predict actual
in vivo performance;
     The need and utility for each test; and
     The potential testing paradigms, including when certain
tests should be considered, and how to establish acceptance criteria
for each test.

III. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public workshop from the
posted events list), approximately 45 days after the public workshop.

    Dated: February 1, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-2583 Filed 2-3-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 221 (Wednesday, November 16, 2016)]
[Notices]
[Page 80662]
[FR Doc No: 2016-27448]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10674-016]

Kaukauna Utilities; Notice of Intent To File License Application,
Filing of Pre-Application Document, and Approving Use of the
Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 10674-016.
    c. Date Filed: September 23, 2016.
    d. Submitted By: Kaukauna Utilities.
    e. Name of Project: Kimberly Hydroelectric Project.
    f. Location: On the Fox River, at the U.S. Army Corps of Engineers'
Cedars Dam in the Village of Kimberly in Outagamie County, Wisconsin.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Mike Pedersen, Manager of
Generation and Operations, Kaukauna Utilities, 777 Island Street, P.O.
Box 1777, Kaukauna, WI 54130-7077, phone:<PHONE_NUMBER>.
    i. FERC Contact: Colleen Corballis at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Kaukauna Utilities filed its request to use the Traditional
Licensing Process on September 23, 2016. Kaukauna Utilities provided
public notice of its request on October 25, 2016. In a letter dated
November 8, 2016, the Director of the Division of Hydropower Licensing
approved Kaukauna Utilities's request to use the Traditional Licensing
Process.
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, Part 402; (b) NOAA Fisheries under section 305(b)
of the Magnuson- Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920; and (c) the Wisconsin State
Historic Preservation Officer, as required by section 106, National
Historical Preservation Act, and the implementing regulations of the
Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Kaukauna Utilities as the
Commission's non-federal representative for carrying out informal
consultation, pursuant to section 7 of the Endangered Species Act;
section 305 of the Magnuson-Stevens Fishery Conservation and Management
Act; and section 106 of the National Historic Preservation Act.
    m. Kaukauna Utilities filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 10674. Pursuant to 18 CFR
16.8, 16.9, and 16.10 each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by September
30, 2019.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: November 8, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-27448 Filed 11-15-16; 8:45 am]
 BILLING CODE 6717-01-P