[Federal Register Volume 79, Number 191 (Thursday, October 2, 2014)]
[Notices]
[Page 59523]
[FR Doc No: 2014-23453]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension: Rule 15c2-1,
    SEC File No. 270-418, OMB Control No. 3235-0485.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 15c2-1, (17 CFR
240.15c2-1), under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.). The Commission plans to submit this existing collection of
information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Rule 15c2-1 prohibits the commingling under the same lien of
securities of margin customers (a) with other customers without their
written consent, and (b) with the broker-dealer. The rule also
prohibits the re-hypothecation of customers' margin securities for a
sum in excess of the customer's aggregate indebtedness. Pursuant to
Rule 15c2-1, respondents must collect information necessary to prevent
the re-hypothecation of customer securities in contravention of the
rule, issue and retain copies of notices of hypothecation of customer
securities in accordance with the rule, and collect written consents
from customers in accordance with the rule. The information is
necessary to ensure compliance with the rule, and to advise customers
of the rule's protections.
    There are approximately 61 respondents (i.e., broker-dealers that
conducted business with the public, filed Part II or Part IICSE of the
FOCUS Report, did not claim an exemption from the Rule 15c3-3 reserve
formula computation, and reported that they had a bank loan during at
least one quarter of the current year) that require an aggregate total
of 1,373 hours to comply with the rule. Each of these approximately 61
registered broker-dealers makes an estimated 45 annual responses. Each
response takes approximately 0.5 hours to complete. Thus, the total
compliance burden per year is 1,373 burden hours.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Thomas Bayer, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
     Dated: September 26, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-23453 Filed 10-1-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Notices]
[Pages 62751-62752]
[FR Doc No: 2020-21869]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2020-0618]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0062

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0062,
Approval of Alterations to Marine Portable Tanks; Approval of Non-
Specification Portable Tanks; without change. Our ICR describes the
information we seek to collect from the public. Before submitting this
ICR to OIRA, the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before December 4,
2020.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2020-0618] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: COMMANDANT (CG-6P), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S.
COAST GUARD, 2703 MARTIN LUTHER KING JR. AVE. SE, STOP 7710,
WASHINGTON, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information

(Collection). The ICR contains information describing the Collection's
purpose, the Collection's likely burden on the affected public, an
explanation of the necessity of the Collection, and other important
information describing the Collection. There is one ICR for each
Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. Consistent with
the requirements of Executive Order 13771, Reducing Regulation and
Controlling Regulatory Costs, and Executive Order 13777, Enforcing the
Regulatory Reform Agenda, the Coast Guard is also requesting comments
on the extent to which this request for information could be modified
to reduce the burden on respondents.
    In response to your comments, we may revise this ICR or decide not
to seek an extension of approval for the Collection. We will consider
all comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2020-0618], and
must be received by December 4, 2020.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records notice (85 FR 14226, March 11, 2020).

Information Collection Request

    Title: Approval of Alterations to Marine Portable Tanks; Approval
of Non-Specification Portable Tanks.
    OMB Control Number: 1625-0062.
    Summary: The information will be used to evaluate the safety of
proposed alterations to marine portable tanks and non-specification
portable tank designs used to transfer hazardous materials during
offshore operations.
    Need: The information will be used to evaluate the safety of
proposed alterations to marine portable tanks and non-specification
portable tank designs used to transfer hazardous materials during
offshore operations.
    Forms: Not applicable.
    Respondents: Owners of marine portable tanks and owners/designers
of non-specification portable tanks.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden remains 18 hours a year.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
chapter 35, as amended.

    Dated: September 29, 2020.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2020-21869 Filed 10-2-20; 8:45 am]
BILLING CODE 9110-04-P


" Graff Zivin, Joshua" < Joshua_ Graff_ Zivin@ cea. eo p. gov>

02/ 28/ 2005 03: 18 PM To " Flynn, Amy E." < Amy_ E._ Flynn@ omb. eop. gov> cc Lydia Wegman/ RTP/ USEPA/ US@ EPA Subject RE: Revised DE NJ rule for OMB They seem to have done a nice job of addressing my major concerns.

Josh  Original Message From: Flynn, Amy E. Sent: Friday, February 25, 2005 6: 07 PM To: Graff Zivin, Joshua; ' David. R. Hill@ hq. doe. gov' Subject: FW: Revised DE NJ rule for OMB FYI

Revised CAIR DE/ NJ Proposal.

 Original Message From: Wegman. Lydia@ epamail. epa. gov [ mailto: Wegman. Lydia@ epamail. epa. gov]

Sent: Friday, February 25, 2005 5: 00 PM To: Fraas, Arthur G.; Flynn, Amy E. Cc: holmstead. jeff@ epamail. epa. gov; brenner. rob@ epamail. epa. gov; wehrum. bill@ epamail. epa. gov; zinger. don@ epamail. epa. gov; Meyers. Robert@ epamail. epa. gov; page. steve@ epamail. epa. gov; green. gregory@ epamail. epa. gov; napolitano. sam@ epamail. epa. gov; Bachmann. Johnd@ epamail. epa. gov; tsirigotis. peter@ epamail. epa. gov; culligan. kevin@ epamail. epa. gov; mclean. kevin@ epamail. epa. gov; daigle. stephanie@ epamail. epa. gov; Cristofaro. Alexander@ epamail. epa. gov; lorang. phil@ epamail. epa. gov; King. Jan@ epamail. epa. gov; oldham. carla@ epamail. epa. gov; ketcham colwill. jim@ epamail. epa. gov; possiel. norm@ epamail. epa. gov; paisie. joe@ epamail. epa. gov; chappell. linda@ epamail. epa. gov; evans. ron@ epamail. epa. gov Subject: Revised DE NJ rule for OMB Art and Amy

Please find attached a clean and a redlined version of the revised NJ/ DE proposal package. We believe we have responded to all of your comments. Art, I hope that you have had a chance to talk with Linda Chappell about your interest in showing incremental costs and benefits for this rule. If you haven't yet talked to her, let me know and we can try to discuss it during our Monday call on the recession and section 110( a) language. Thanks. ( See attached file: CAIR NJ DE NPR 2 25 05omb rev. wpd)( See attached file: CAIR DE NJ NPR 2 25 05omb redline. wpd)


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

General Comment:Dear Mr. Zeller:

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

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

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that I would not have been able to stop smoking without them, and without the many available options currently available on the market, where I was able to try different ones to find what best worked for me.  I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

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


[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Pages 43800-43802]
[FR Doc No: 2017-19845]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81605; File No. SR-ISE-2017-81]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Its
Schedule of Fees To Increase the Priority Customer Taker Fee for
Regular Orders in SPY

September 13, 2017.
    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 September 1, 2017, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II, below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.

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

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

    The Exchange proposes to amend its Schedule of Fees to increase the
Priority Customer taker fee for regular orders in SPY, as discussed
further below.
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend the Schedule of
Fees to increase the Priority Customer \3\ taker fee for regular orders
in SPY, which is the most actively traded name on the Exchange.
---------------------------------------------------------------------------

    \3\ A ``Priority Customer'' is a person or entity that is not a
broker/dealer in securities, and does not place more than 390 orders
in listed options per day on average during a calendar month for its
own beneficial account(s), as defined in Nasdaq ISE Rule
100(a)(37A).
---------------------------------------------------------------------------

    Currently, the Exchange charges a taker fee for regular orders in
Select Symbols \4\ that is $0.44 per contract for Market Maker \5\
orders, $0.45 per contract for Non-Nasdaq ISE Market Maker,\6\ Firm
Proprietary,\7\ Broker-Dealer,\8\ and Professional Customer \9\ orders,
and $0.44 per contract for Priority Customer orders. In addition, the
Exchange charges a reduced Priority Customer taker fee that is $0.30
per contract for regular orders in SPY, and $0.35 per contract for
regular orders in QQQ, IWM and VXX.
---------------------------------------------------------------------------

    \4\ ``Select Symbols'' are options overlying all symbols listed
on the Nasdaq ISE that are in the Penny Pilot Program.
    \5\ The term ``Market Makers'' refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively. See ISE Rule
100(a)(25).
    \6\ A ``Non-Nasdaq ISE Market Maker'' is a market maker as
defined in Section 3(a)(38) of the Securities Exchange Act of 1934,
as amended, registered in the same options class on another options
exchange.
    \7\ A ``Firm Proprietary'' order is an order submitted by a
member for its own proprietary account.
    \8\ A ``Broker-Dealer'' order is an order submitted by a member
for a broker-dealer account that is not its own proprietary account.
    \9\ A ``Professional Customer'' is a person or entity that is
not a broker/dealer and is not a Priority Customer.
---------------------------------------------------------------------------

    The Exchange now proposes to increase the Priority Customer taker
fee for regular orders in SPY from $0.30 per contract to $0.34 per
contract. This taker fee will remain unchanged for Select Symbols other
than SPY.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\10\ in general, and
Section 6(b)(4) of the Act,\11\ in particular, in that it is designed
to provide for the equitable allocation of reasonable dues, fees, and
other charges among its members and other persons using its facilities.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f.
    \11\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that it is reasonable and equitable to
increase the Priority Customer taker fee for regular orders in SPY
because the proposed fee remains lower than both the Priority Customer
taker fees that the Exchange currently charges for other Select
Symbols, including QQQ, IWM and VXX, and the fees charged to other
market participants that remove liquidity on the Exchange. As such, the
Exchange believes that the proposed pricing for SPY, which is the most
actively traded name on ISE, will continue to attract Priority Customer
order flow in SPY to the benefit of all members that trade on the
Exchange. The Exchange further notes that the proposed Priority
Customer taker fee for SPY is still lower than the rate charged by one
of the Exchange's competitors.\12\
---------------------------------------------------------------------------

    \12\ See MIAX Pearl Fee Schedule, Section 1(a) at: https://www.miaxoptions.com/sites/default/files/fee_schedule-files/MIAX_PEARL_Fee_Schedule_06302017.pdf.
---------------------------------------------------------------------------

    In addition, the Exchange believes that it is equitable and not
unfairly discriminatory to only offer the proposed taker fee to
Priority Customer orders. A Priority Customer is by definition not a
broker or dealer in securities, and does not place more than 390 orders
in listed options per day on average during a calendar month for its
own beneficial account(s). This limitation does not apply to
participants on the Exchange whose behavior is substantially similar to
that of market professionals, including Professional Customers, who
will generally submit a higher number of orders than Priority
Customers.

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

    In accordance with Section 6(b)(8) of the Act,\13\ the Exchange
does not believe that the proposed rule change will impose any burden
on intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
believes that the proposed fee remains competitive with those on other
options markets, and will continue to attract order flow to the
Exchange. The Exchange operates in a highly competitive market in which
market participants can readily direct their order flow to competing
venues. In such an environment, the Exchange must continually review,
and consider adjusting, its fees and rebates to remain competitive with
other exchanges. For the reasons described above, the Exchange believes
that the proposed fee changes reflect this competitive environment.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\14\ and Rule 19b-4(f)(2) \15\ thereunder.
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: (i) Necessary or
appropriate in the public interest; (ii) for the protection of
investors; or (iii) otherwise in furtherance of the purposes of the
Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \15\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule

change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2017-81 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2017-81. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2017-81 and should be
submitted on or before October 10, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
Robert W. Errett,
Deputy Secretary.
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2017-19845 Filed 9-18-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 179 (Monday, September 16, 2019)]
[Notices]
[Page 48664]
[FR Doc No: C1-2019-18999]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86784; File No. SR-NYSE-2019-45]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Its Price List To Revise the Remove and Adding Liquidity Tiers
for Tape B and C Securities

Correction

    In notice document 2019-18999 beginning on page 46588 in the issue
of Wednesday, September 4, 2019, make the following correction:
    On page 46593, in the third column, in the first paragraph,
starting in the two last lines ``September 24, 2019'' should read
``September 25, 2019''.

[FR Doc. C1-2019-18999 Filed 9-13-19; 8:45 am]
 BILLING CODE 1301-00-P


[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75334-75336]
[FR Doc No: 2020-26051]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0529]

Qualification Process for Drug Development Tools; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) and Center for Biologics Evaluation
and Research (CBER) are announcing the availability of a final guidance
for industry and FDA staff entitled ``Qualification Process for Drug
Development Tools.'' Under the 21st Century Cures Act (Cures Act),
enacted on December 13, 2016, a new section was added to the Federal
Food, Drug, and Cosmetic Act (FD&C Act), which defined a three-stage
qualification process for drug development tools (DDTs). This guidance
meets the Cures

Act's requirement to issue guidance on this qualification process. It
elaborates on the new qualification process and transparency
requirements and discusses the taxonomy for biomarkers and other DDTs.
This guidance finalizes the draft guidance of the same title issued on
December 16, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on November 25, 2020.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-D-0529 for ``Qualification Process for Drug Development
Tools.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this 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; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Chris Leptak, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993-0002, 301-
796-0017; or Stephen Ripley, Center for Biologics Evaluation and
Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993-0002;<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    CDER and CBER are announcing the availability of a final guidance
for industry and FDA staff entitled ``Qualification Process for Drug
Development Tools.'' Signed into law on December 13, 2016, the Cures
Act codified, in new section 507 of the FD&C Act (21 U.S.C. 357), a new
statutory process for DDT qualification and added transparency
provisions for information related to qualification submissions through
which there is enhanced ability to share knowledge. In addition,
Congress directed the establishment of a taxonomy for the
classification of biomarkers (and related scientific concepts) for use
in drug (including biological product) development. CDER and CBER
convened a public meeting on December 11, 2018, to solicit public input
about implementing the new qualification process under section 507 of
the FD&C Act and about identifying the Biomarkers, EndpointS, and other
Tools (BEST) glossary as the taxonomy for classifying types of DDTs,
including biomarkers. CDER and CBER are issuing this final guidance to
meet the Cures Act requirement that the Agency issue final guidance on
the section 507 qualification process.
    DDTs are methods, materials, or measures that can aid drug
development and regulatory review. Qualification means that a DDT and
its proposed context of use can be relied upon to have a specific
interpretation and application in drug development and regulatory
review. Qualified DDTs can accelerate the integration of innovation,
clinical knowledge, and scientific advances, thereby expediting drug
development and aiding the regulatory review of applications.
    Although the DDT qualification process is voluntary, requestors who
seek qualification under section 507 of the FD&C Act must follow the
three-

stage process described in the Cures Act. This consists of the
following stages: The Letter of Intent, the Qualification Plan, and the
Full Qualification Package. These stages are discussed in detail in
section III of the final guidance.
    The Cures Act includes transparency provisions that require the
Agency to make information with respect to qualification submissions
publicly available. A description of information that is made public on
the Agency's website is provided in section II of the final guidance.
    CDER and CBER have considered public comments made during the
December 11, 2018, public meeting and submitted to the docket in
developing the draft guidance of the same title published on December
16, 2019 (84 FR 68460). The Agency received various comments to the
docket in response to the publication of the draft guidance and has
considered those comments in developing this final guidance. Changes
made in the final guidance in response to comments include requests for
additional clarity on the qualification process, support for the
proposed time frames, and requests to reference specific programs'
content element outlines in the guidance. This final guidance meets the
Cures Act's requirement to finalize guidance on the section 507
qualification process and affirms the BEST glossary as the taxonomy for
classifying types of DDTs. This guidance does not address evidentiary
standards for purposes of DDT qualification. It also does not address
the qualification of medical device development tools or other programs
under the Center for Devices and Radiological Health oversight, which
are not addressed in section 507 of the FD&C Act.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the ``Qualification Process for Drug
Development Tools.'' 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The previously
approved collections of information are subject to review by OMB under
the PRA. The collections of information pertaining to submissions of
investigational new drug applications have been approved under OMB
control number 0910-0014; the collections of information pertaining to
submissions of new drug applications and abbreviated new drug
applications have been approved under OMB control number 0910-0001; and
the collections of information pertaining to submissions of biologics
license applications in 21 CFR part 601 have been approved under OMB
control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or
https://www.regulations.gov.

    Dated: November 19, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26051 Filed 11-24-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 8, 2008 (Volume 73, Number 131)]
[Proposed Rules]
[Page 38954-38955]
[DOCID:fr08jy08-30]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R05-OAR-2008-0952; FRL-8687-9]

Direct Final Approval of Revised Municipal Waste Combustor State
Plan for Designated Facilities and Pollutants: Indiana

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is approving revisions to Indiana's State Plan to control
air pollutants from large Municipal Waste Combustors (MWC). The Indiana
Department of Environmental Management (IDEM) submitted the State Plan
on August 24, 2007. The revisions are consistent with Emission
Guideline (EG) amendments promulgated by EPA on May 10, 2006. This
approval means that EPA finds that the State Plan amendments meet
applicable Clean Air Act (Act) requirements for large MWCs for which
construction commenced on or before September 20, 1994. Once effective,
this approval also makes the amended State Plan Federally enforceable.

DATES: Comments must be received on or before August 7, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2008-0952, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Carlton T. Nash, Chief, Integrated Air Toxics
Section, Air Toxics and Assessment Branch (AT-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
     Hand Delivery: Carlton T. Nash, Chief, Integrated Air
Toxics Section, Air Toxics and Assessment Branch (AT-18J), U.S.
Environmental Protection Agency, 77 West Jackson Boulevard, Chicago,
Illinois 60604. Such deliveries are only accepted during the Regional
Office normal hours of operation, and special arrangements should be
made for deliveries of boxed information. The Regional Office official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.
excluding Federal holidays.
Please see the direct final rule which is located in the Rules section
of this Federal Register for detailed instructions on how to submit
comments.

FOR FURTHER INFORMATION CONTACT: Margaret Sieffert, Environmental
Engineer, Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard (AT-18J), Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Michele Palmer, Environmental Engineer,
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard
(ML-10C), Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: June 24, 2008.
Richard C. Karl,
Acting Regional Administrator, Region 5.
[FR Doc. E8-15347 Filed 7-7-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Page 23952]
[FR Doc No: 2020-09194]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. TX20-3-000]

City of Goose Creek, South Carolina; Notice of Filing

    Take notice that on April 23, 2020, pursuant to sections 211 and
212 of the Federal Power Act,\1\ and Rule 204 and 212 of the Federal
Energy Regulatory Commission's (Commission) Rules of Practice and
Procedure,\2\ the City of Goose Creek, South Carolina filed an
application requesting that the Commission issue an order directing the
South Carolina Public Service Authority to provide transmission service
to the City of Goose Creek.
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 824j, 824k (2019).
    \2\ 18 CFR 385.204, 385.212 (2019).
---------------------------------------------------------------------------

    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 on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant. On or before the comment date, it is
not necessary to serve motions to intervene or protests on persons
other than the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on May 14, 2020.

    Dated: April 24, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-09194 Filed 4-29-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Proposed Rules]
[Pages 6590-6593]
[FR Doc No: 2011-2605]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2010-1082; FRL-9262-6]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Determination of Attainment for the Pittsburgh-Beaver
Valley 8-Hour Ozone Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to make a determination that the Pittsburgh-
Beaver Valley 8-hour ozone nonattainment area (the Pittsburgh Area) has
attained the 1997 8-hour ozone national ambient air quality standards
(NAAQS). This proposed determination is based upon complete, quality
assured, and certified ambient air monitoring data that show the area
has monitored attainment of the 1997 8-hour ozone NAAQS for the 2007 to
2009 monitoring period. Preliminary air quality monitoring data
available for 2010 are consistent with continued attainment. If this
proposed determination is made final, the requirement for the
Commonwealth of Pennsylvania to submit an attainment demonstration and
associated reasonably available control measures (RACM), a reasonable
further progress (RFP) plan, contingency measures, and other planning
requirements related to attainment of the 1997 8-hour ozone NAAQS for
the Pittsburgh Area shall be suspended for as long as the nonattainment
area continues to meet the 1997 8-hour ozone NAAQS. This action is
being taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before March 9, 2011.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2010-1082 by one of the following methods
    A. www.regulations.gov. Follow the online instructions for
submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2010-1082, Cristina Fernandez, Associate
Director, Office of Air Quality Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2010-1082. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail 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, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., 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 in http://www.regulations.gov or in hard copy 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: Maria A. Pino,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For detailed information regarding this
proposal, EPA prepared a Technical Support Document (TSD). The TSD can
be viewed at http://www.regulations.gov. The following outline is
provided to aid in locating information in this action.

I. What is EPA proposing?
II. What is the background for this action?
III. What is the effect of this action?
IV. What is EPA's analysis of the relevant air quality data?
V. Proposed Action
VI. Statutory and Executive Order Reviews

I. What is EPA proposing?

    EPA is proposing to determine that the Pittsburgh Area has attained
the 1997 8-hour ozone NAAQS. The Pittsburgh Area is comprised of
Allegheny, Armstrong, Beaver, Butler, Fayette, Washington, and
Westmoreland Counties in Pennsylvania. EPA's determination is based
upon complete, quality assured, quality controlled, and certified
ambient air quality monitoring data for the years 2007 to 2009 showing
that the Pittsburgh Area has monitored attainment of the 1997 8-hour
ozone NAAQS. Preliminary air quality monitoring data available for 2010
are consistent with continued attainment.
    On March 27, 2008 (73 FR 16436), EPA promulgated a revised 8-hour
ozone standard of 0.075 parts per million (ppm). On January 6, 2010,
EPA again addressed this 2008 revised standard and proposed to set the
primary 8-hour ozone standard within the range of 0.060 to 0.070 ppm,
rather than at 0.075 ppm. EPA is working to complete reconsideration of
the standard and thereafter will proceed with attainment/nonattainment
area designations. This proposed rulemaking relates only to a
determination of attainment for the 1997 8-hour ozone standard and is
not affected by the ongoing process of reconsidering the revised 2008
standard. This action addresses only the 1997 8-hour ozone standard of
0.08 ppm, and does not address any subsequently revised 8-hour ozone
standard.

II. What is the background for this action?

A. The Pittsburgh Area

    In 1997, EPA revised the health-based NAAQS for ozone, setting it
at 0.08 ppm averaged over an 8-hour time frame. EPA set the 8-hour
ozone standard based on scientific evidence demonstrating that ozone
causes adverse health effects at lower ozone concentrations and over
longer periods of time, than was understood when the pre-existing 1-
hour ozone standard was set. EPA determined that the 8-hour standard
would be more protective of human health, especially children and
adults who are active outdoors, and individuals with a pre-existing
respiratory disease, such as asthma.
    On April 30, 2004 (69 FR 23951), EPA finalized its attainment/
nonattainment designations for areas across the country with respect to
the 8-hour ozone standard. These actions became effective on June 15,
2004. Among those nonattainment areas is the Pittsburgh Area, which
includes Allegheny, Armstrong, Beaver, Butler, Fayette, Washington, and
Westmoreland Counties in Pennsylvania. See 40 CFR 81.339.

B. Determination of Attainment

    Under the provisions of EPA's ozone implementation rule (see 40 CFR
51.918), if EPA issues a determination that an area is attaining the
relevant standard (through a rulemaking that includes public notice and
comment), it will suspend the area's obligations to submit an
attainment demonstration, RACM, RFP, contingency measures and other
planning requirements related to attainment for as long as the area
continues to attain. The determination of attainment is not equivalent
to a redesignation. The state must still meet the statutory
requirements for redesignation in order to be redesignated to
attainment.

C. Ambient Air Quality Monitoring Data

    Complete, quality assured, certified 8-hour ozone air quality
monitoring data for 2007 through 2009, as well as preliminary data
available to date for 2010, show that the Pittsburgh Area has attained
the 1997 8-hour ozone NAAQS.

III. What is the effect of this action?

    As noted, if the proposed action is finalized, under 40 CFR section
51.918 it will suspend the obligation to submit

certain planning requirements described above; however, it will not
constitute a redesignation to attainment under section 107(d)(3) of the
CAA. The designation status of the Pittsburgh Area will remain
nonattainment for the 1997 8-hour ozone NAAQS until such time as EPA
determines that the area meets the CAA requirements for redesignation
to attainment, including an approved maintenance plan.

A. Determination of Attainment

    EPA is proposing to determine that the Pittsburgh Area is attaining
the 1997 8-hour ozone NAAQS. In accordance with 40 CFR 51.918, if EPA
finalizes this determination, the obligation under the CAA for the
Commonwealth of Pennsylvania to submit an attainment demonstration and
RACM, RFP plan, contingency measures, and any other planning
requirements related to attainment of the 1997 8-hour ozone NAAQS for
the Pittsburgh Area would be suspended for so long as the area
continues to attain the 1997 8-hour ozone NAAQS. Although these
requirements are suspended, EPA is not precluded from acting upon these
elements, if Pennsylvania submits them for EPA review and approval.
    If finalized, the proposed determination will:
    (1) Suspend the requirements to submit an attainment demonstration,
RACM, RFP plan, contingency measures, and any other planning
requirements related to attainment of the 1997 8-hour ozone NAAQS;
    (2) Continue until such time, if any, that EPA (i) redesignates the
area to attainment at which time those requirements no longer apply, or
(ii) subsequently determines that the area has violated the 1997 8-hour
ozone NAAQS;
    (3) Be separate from, and not influence or otherwise affect, any
future designation determination or requirements for the area based on
any new or revised ozone NAAQS; and
    (4) Remain in effect regardless of whether EPA designates this area
as a nonattainment area for purposes of any new or revised ozone NAAQS.
    If this rulemaking is finalized and EPA subsequently determines,
after notice-and-comment rulemaking, that the Pittsburgh Area has
violated the 1997 8-hour ozone NAAQS, the basis for the suspension of
the specific requirements, set forth at 40 CFR 51.918, would no longer
exist, and the Pittsburgh Area would thereafter have to address
applicable requirements.

B. Subpart 1 Designation

    Under the implementation rule for the 1997 8-hour ozone standard,
EPA designated certain areas under title I, part D, subpart 1 of the
CAA (subpart 1) if they had a 1-hour design value below 0.121 ppm. In
June 2004, EPA designated the Pittsburgh Area nonattainment under
subpart 1 for the 1997 8-hour ozone standard. In June 2007, the United
States Court of Appeals for the District of Columbia Circuit (D.C.
Circuit Court) vacated the portion of the 1997 ozone implementation
rule that allowed areas to be designated under subpart 1. On January
16, 2009 (74 FR 2936), EPA published a proposed rule to address, among
other issues, the D.C. Circuit Court vacatur of the classification
system that EPA used to designate a subset of initial 1997 8-hour ozone
nonattainment areas under subpart 1. In that rulemaking, EPA proposed
that all areas designated nonattainment for the 1997 8-hour ozone NAAQS
under subpart 1 would be classified as subpart 2 areas (hereafter
referred to as the ``Subpart 1/Subpart 2 1997 8-Hour Ozone
Rulemaking''). The Pittsburgh Area is among those areas that would be
classified under subpart 2 if EPA's proposal is finalized. EPA has not
yet completed its final rulemaking action for the Subpart 1/Subpart 2
1997 8-Hour Ozone Rulemaking. When the Subpart 1/Subpart 2 1997 8-Hour
Ozone Rulemaking is finalized, and if the Pittsburgh Area continues in
attainment for the 1997 8-hour ozone NAAQS, EPA will address in a
future rulemaking the consequences of a determination of attainment for
any requirements to which the Pittsburgh Area becomes subject as a
result of its reclassification. If, after the Pittsburgh Area is
classified under subpart 2, EPA determines in a future rulemaking that
the Pittsburgh Area continues to be in attainment, then the obligation
to submit the applicable attainment-related requirements for its new
classification would be suspended in accordance with 40 CFR 51.918.

IV. What is EPA's analysis of the relevant air quality data?

    Under EPA regulations at 40 CFR part 50, the 1997 8-hour ozone
standard is attained at a site when the 3-year average of the annual
fourth-highest daily maximum 8-hour average ozone concentrations at an
ozone monitor is less than or equal to 0.08 ppm. This 3-year average is
referred to as the design value. When the design value is less than or
equal to 0.084 ppm (based on the rounding convention in 40 CFR part 50,
appendix I) at each monitoring site within the area, then the area is
meeting the NAAQS. The data completeness requirement is met when the
average percent of days with valid ambient monitoring data is greater
than 90%, and no single year has less than 75% data completeness as
determined in Appendix I of 40 CFR Part 50.
    Consistent with the requirements contained in 40 CFR part 50, EPA
has reviewed the ozone ambient air monitoring data for the monitoring
period from 2007 through 2009 for the Pittsburgh Area, as recorded in
the EPA Air Quality System (AQS) database. On the basis of that review,
EPA has concluded that this area attained the 1997 8-hour ozone NAAQS
based on data for the 2007-2009 ozone seasons. Table 1 shows the ozone
design values for the Pittsburgh Area monitors based on 2007-2009
ambient air quality monitoring data. Preliminary data available for
2010, summarized in Table 2, are also consistent with continued
attainment.

                          Table 1--2007-2009 Pittsburgh Area 8-Hour Ozone Design Values
----------------------------------------------------------------------------------------------------------------
                                                                       2007-2009 Average %    2007-2009 Design
                    County                           Monitor ID         data completeness        value (ppm)
----------------------------------------------------------------------------------------------------------------
Allegheny.....................................             420030008                    99                 0.077
                                                           420030010                    99                 0.074
                                                           420030067                    98                 0.073
                                                           420031005                    97                 0.082
Armstrong.....................................             420050001                   100                 0.077
Beaver........................................             420070002                    97                 0.073
                                                           420070005                    97                 0.071
                                                           420070014                   100                 0.073
Washington....................................             421250005                    99                 0.072
                                                           421250200                   100                 0.068

                                                           421255001                    95                 0.072
Westmoreland..................................             421290006                   100                 0.071
                                                           421290008                    99                 0.072
----------------------------------------------------------------------------------------------------------------

                    Table 2--Preliminary 2008-2010 Pittsburgh Area 8-Hour Ozone Design Values
----------------------------------------------------------------------------------------------------------------
                                                                                Preliminary 2008-
                    County                           Monitor ID        2008-2010 Average %    2010 Design value
                                                                        data completeness           (ppm)
----------------------------------------------------------------------------------------------------------------
Allegheny.....................................             420030008                    98                 0.076
                                                           420030010                    96                 0.072
                                                           420030067                    99                 0.074
                                                           420031005                    99                 0.082
Armstrong.....................................             420050001                   100                 0/076
Beaver........................................             420070002                    97                 0.071
                                                           420070005                    96                 0.073
                                                           420070014                    95                 0.072
Washington....................................             421250005                    99                 0.070
                                                           421250200                    99                 0.068
                                                           421255001                    94                 0.071
Westmoreland..................................             421290006                    99                 0.069
                                                           421290008                    98                 0.072
----------------------------------------------------------------------------------------------------------------

    EPA's review of the data indicates that the Pittsburgh Area has met
the 1997 8-hour ozone NAAQS. Additional information on air quality data
for the Pittsburgh Area can be found in the TSD.

V. Proposed Action

    EPA is proposing to determine that the Pittsburgh Area has attained
the 1997 8-hour ozone NAAQS based on 2007-2009 complete, quality-
assured, and certified ambient air quality monitoring data. Preliminary
data available to date for 2010 are consistent with continued
attainment. As provided in 40 CFR 51.918, if EPA finalizes this
determination, it would suspend the requirements for the Commonwealth
of Pennsylvania to submit, for the Pittsburgh Area, an attainment
demonstration and associated RACM, RFP plan, contingency measures, and
any other planning requirements related to attainment of the 1997 8-
hour ozone NAAQS as long as the area continues to attain the 1997 8-
hour ozone NAAQS. EPA is soliciting public comments on the issues
discussed in this document. These comments will be considered before
taking final action.

VI. Statutory and Executive Order Reviews

    This action proposes to make a determination of attainment based on
air quality, and would, if finalized, result in the suspension of
certain federal requirements, and would not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     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);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed determination that the Pittsburgh Area
has attained the1997 8-hour ozone NAAQS does not have tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Ozone, Reporting and recordkeeping requirements.

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

    Dated: January 24, 2011.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2011-2605 Filed 2-4-11; 8:45 am]
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