[Federal Register Volume 77, Number 197 (Thursday, October 11, 2012)]
[Notices]
[Pages 61800-61802]
[FR Doc No: 2012-24979]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67980; File No. SR-EDGA-2012-45]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Amendments to the EDGA Exchange, Inc. Fee Schedule

October 4, 2012.
    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 October 1, 2012 the EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its fees and rebates applicable to
Members \3\ of the Exchange pursuant to EDGA Rule 15.1(a) and (c). Text
of the proposed rule change is attached as Exhibit 5 at http://www.directedge.com/Regulation/ExchangeRuleFilings/EDGA.aspx.
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    \3\ As defined in Exchange Rule 1.5(n).
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

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

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

1. Purpose
    On the Exchange's fee schedule, the Exchange currently charges a
Member $0.0020 per share for orders that yield Flag Q, where the
Member's order is routed using the ROUQ \4\ or ROUC \5\ routing
strategy and executes at non-exchange destinations. The pricing of Flag
Q is also subject to the volume tiers detailed in Footnote 16, which
currently states that where a Member posts greater than or equal to
0.30% of the Total Consolidated Volume (``TCV'') in Average Daily
Volume (``ADV'') on EDGA and routes 2.5 million shares via Flag Q, then
the Member's rate for Flag Q decreases to $0.0015 per share. Footnote
16 also states that where a Member posts greater than or equal to 0.30%
of the TCV in ADV on EDGA and routes 5 million shares via Flag Q, then
the Member's rate for Flag Q decreases to $0.0010 per share. The
Exchange proposes to expand the volume tiers in Footnote 16 to add
additional criteria to achieve a lower rate of $0.0015 per share.
Specifically, Members will be assessed a charge of $0.0015 per share
for orders that yield Flag Q where a Member executes greater than or
equal to an average daily volume of 12 million shares using the ROUC
routing strategy and yields Flags C, D, I, K, Q, X, BY, CR and MT. The
Exchange notes that Flags C, D, I, K, Q, X, BY, CR and MT correspond to
the destinations on the System routing table \6\ where orders using the
ROUC routing strategy may be executed; therefore, the Exchange proposes
to count the volume generated from these flags in the proposed volume
tier for Flag Q as described in Footnote 16.
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    \4\ As defined in Exchange Rule 11.9(b)(3)(c)(iv).
    \5\ As defined in Exchange Rule 11.9(b)(3)(a).
    \6\ Exchange Rule 11.9(b)(3) defines the ``System routing
table'' as the proprietary process for determining the specific
trading venues to which the System, as defined in Exchange Rule
1.5(cc), routes orders and the order in which the System routes to
them.
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    The Exchange proposes to amend the description of Flag Q on the
Exchange's fee schedule in order to provide Members additional
transparency that orders that are routed using ROUQ or ROUC may execute
at non-exchange destinations, yielding Flag Q. Therefore, the Exchange
proposes to revise the description of Flag Q to state that Flag Q
encompasses orders routed using the ROUQ or ROUC routing strategy that
execute at non-exchange destinations on the System routing table. The
Exchange notes that its proposal does not modify the existing routing
functionality associated with Flag Q; but rather, the Exchange's
proposal clarifies that orders yielding Flag Q are executed at non-
exchange destinations.
    The Exchange proposes to amend the description of Flag MT on the
Exchange's fee schedule in order to provide Members additional
transparency. Currently, the Exchange's fee schedule states that orders
routed to EDGX Exchange, Inc., (``EDGX'') Mid-Point Match (``MPM'')
using the IOCM or ROCO routing strategies, as defined in Exchange Rule
11.9(b)(3), will yield Flag MT. The Exchange proposes to revise the
description of Flag MT on the Exchange's fee schedule to include ICMT
and ROUC, as defined in Exchange Rule 11.9(b)(3), among the routing
strategies listed. Accordingly, Members' orders that are routed to EDGX
MPM using ICMT, IOCM, ROCO or ROUC routing strategies will yield Flag
MT. The Exchange notes that its proposal does not modify the existing
routing functionality associated with Flag MT; but rather, the
Exchange's proposal modifies the fee schedule to reflect the specific
routing strategies utilized and yielding Flag MT.
    Currently, the Exchange offers Members a rebate of $0.0005 per
share for orders that are routed to NASDAQ OMX BX, Inc. (the ``BX'')
and remove liquidity, yielding Flag C. The Exchange proposes to
increase the rebate earned by Members' orders that yield Flag C to a
$0.0014 per share rebate.\7\ The Exchange also proposes to remove
Footnote 7 in its entirety, which is appended to Flag C, thereby
removing the condition that requires Members to post an ADV of 25,000
shares to the BX (yielding Flag RB) because the Exchange is proposing a
rebate of $0.0014 per share for all Members' orders that yield Flag C.
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    \7\ Currently, the Exchange offers Members a default rebate of
$0.0005 per share for orders that yield Flag C, where ``default''
refers to the standard rebate offered by the Exchange to Members for
orders that yield Flag C absent Members qualifying for additional
volume tiered pricing. The Exchange offered Members a rebate of
$0.0014 per share where Members posted an ADV of 25,000 shares to
the BX (yielding Flag RB).
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    The Exchange proposes to assess a fee of $0.0025 per share in lieu
of the current fee of $0.0023 per share for Members' orders that are
routed or re-routed to the New York Stock Exchange (``NYSE'') and
remove liquidity, yielding Flag D. This proposed change represents a
pass-through of the rate that Direct Edge ECN LLC d/b/a DE Route (``DE
Route''), the Exchange's affiliated routing broker dealer, is charged
for routing orders to NYSE, in response to the pricing changes in
NYSE's filing with the Securities and Exchange Commission (the
``SEC'').\8\
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    \8\ See NYSE's Trader Update at http://www.nyse.com/pdfs/NYSE%20Client%20Notice%20Fees%2010%201%202012.pdf (discussing NYSE's
fee changes effective October 1, 2012).
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    The Exchange proposes to implement these amendments to its fee
schedule on October 1, 2012.

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\9\ in general, and
furthers the objectives of Section 6(b)(4),\10\ in particular, as 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.
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    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that its proposal to expand the volume tiers
in Footnote 16 to also assess a charge of $0.0015 per share for orders
that yield Flag Q where a Member executes greater than or equal to an
average daily volume of 12 million shares using the ROUC routing
strategy, which yields Flags C, D, I, K, Q, X, BY, CR and MT,
represents an equitable allocation of reasonable dues, fees and other
charges among its Members and other persons using its facilities. The
ROUC routing strategy initially routes orders to non-exchange
destinations on the System routing table, which are associated with
higher rebates and lower fees, before the orders are routed to higher
cost exchange destinations. The Exchange believes that by initially
routing orders to non-exchange destinations, the likelihood of the
order being executed at the non-exchange destination increases.
Accordingly, the Exchange proposes to pass along the potential cost
savings to Members that DE Route achieves in the form of a reduced
charge for orders that yield Flag Q where those orders are routed to
and executed on these non-exchange destinations.
    In addition, the Exchange also believes that charging Members a
lower rate for achieving volume tiers in Footnote 16 will incentivize
liquidity to the Exchange by increasing the use of the ROUC routing
strategy, which is consistent with EDGA's low cost exchange model
because ROUC offers the Exchange potential cost savings that it can
pass on to its Members given that ROUC routes to a series of low cost
destinations on the System routing table. Such increased volumes
increase potential revenue to the Exchange, and allow the Exchange to
spread its administrative and infrastructure costs over a greater
number of shares, which results in lower per share costs. The Exchange
may then pass on these savings to Members in the form of lower charges.
The increased liquidity also benefits all investors by deepening EDGA's
liquidity pool, offering additional flexibility for all investors to
enjoy cost savings, supporting the quality of price discovery,
promoting market transparency and improving investor protection.
Volume-based discounts such as these have been widely adopted in the
cash equities markets, and are equitable because volume-based discounts
are open to all Members on an equal basis and provide discounts that
are reasonably related to the value to an exchange's market quality
associated with higher levels of market activity, such as higher levels
of liquidity provision and introduction of higher volumes of orders
into the price and volume discovery process. Lastly, the Exchange
believes that the proposed amendment is non-discriminatory because it
applies uniformly to all Members.
    The Exchange believes that the proposed tier is equitable and
reasonable when compared with the existing tier in Footnote 16 that
also offers a discounted rate of $0.0015 per share because the Exchange
regards the criteria of each tier as equally stringent: Members posting
greater than or equal to 0.30% of the TCV in ADV on EDGA and routing
2.5 million shares via Flag Q or Members posting greater than or equal
to an average daily volume of 12 million shares using the ROUC routing
strategy and yielding a variety of flags (i.e., Flags C, D, I, K, Q, X,
BY, CR and MT). As discussed above, because of the potential cost
savings to the Exchange where Members use the ROUC routing strategy,
the Exchange can offer Members a reduced charge of $0.0015 per share
and require less volume than in the existing tier to achieve this rate
given that these two tiers are equally beneficial to the Exchange in
terms of their contribution towards liquidity.
    The Exchange believes that its proposal to amend the description of
Flag Q on the Exchange's fee schedule to state that Flag Q encompasses
orders routed using ROUQ or ROUC and executed at non-exchange
destinations represents an equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities because it supports the Exchange's efforts to provide
additional transparency to Members when reading the fee schedule.
Accordingly, the proposed revised description will advise Members that
Flag Q encompasses orders routed using the ROUQ or ROUC routing
strategy that execute at non-exchange destinations on the System
routing table and yield Flag Q. The Exchange also believes that its
proposed amendment is non-discriminatory because it applies uniformly
to all Members.
    The Exchange believes that its proposal to amend the description of
Flag MT on the Exchange's fee schedule represents an equitable
allocation of reasonable dues, fees and other charges among its Members
and other persons using its facilities because it supports the
Exchanges' efforts to provide additional transparency to Members when
reading the fee schedule. Currently, the Exchange's fee schedule states
that orders routed to EDGX MPM using the IOCM or ROCO routing
strategies will yield Flag MT. The Exchange proposes to revise the
description of Flag MT on the Exchange's fee schedule to include ICMT
and ROUC among the routing strategies listed. Accordingly, the proposed
revised description will advise Members that orders that are routed to
EDGX MPM using ICMT, IOCM, ROCO or ROUC routing strategies will yield
Flag MT. The Exchange also believes that its proposed amendment is non-
discriminatory because it applies uniformly to all Members.
    The Exchange believes that its proposal to increase the rebate
earned by Members' orders that yield Flag C from $0.0005 per share to
$0.0014 per share represents an equitable allocation of reasonable
dues, fees and other charges among its Members and other persons using
its facilities. The Exchange notes that it will provide to its Members
the $0.0014 per share rebate regardless of whether DE Route achieves
the BX tier that requires posting an ADV of 25,000 shares. The Exchange
believes that its proposal to increase the rebate earned by Members'
orders that yield Flag C from $0.0005 per share to $0.0014 per share is
also reasonable given that the BATS BZX Exchange, Inc., the BATS BYX
Exchange, Inc., and NASDAQ OMX Group, Inc. also offer their customers a
rebate of $0.0014 per share for orders that are routed to the BX.\11\
The Exchange also notes that routing through DE Route is voluntary.
Lastly, the Exchange also believes that the proposed amendment is non-
discriminatory because it applies uniformly to all Members.
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    \11\ See NASDAQ OMX Group, Inc., Price List--Trading &
Connectivity at http://nasdaqtrader.com/Trader.aspx?id=PriceListTrading2. See also BATS BZX Exchange, Inc.,
BATS BZX Exchange Fee Schedule (Effective September 10, 2012) and
BATS BYX Exchange, Inc., BATS BYX Exchange Fee Schedule (effective
September 10, 2012), http://cdn.batstrading.com/resources/regulation/rule_book/BATS-Exchanges_Fee_Schedules.pdf.
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    The Exchange currently offers Members a more favorable rebate of
$0.0014 per share for removing liquidity from BX where Members post an
ADV of 25,000 shares to BX, as described in Footnote 7. The Exchange
proposes to

eliminate the volume tier requirement in Footnote 7 in its entirety and
any references thereto, and the Exchange proposes to offer Members a
rebate of $0.0014 per share regardless of their volume. The Exchange
believes that its proposal to delete Footnote 7 from the Exchange's fee
schedule represents an equitable allocation of reasonable dues, fees,
and other charges among its Members and other persons using its
facilities because the Exchange is proposing to amend the rate for
orders that yield Flag C to a rebate of $0.0014 per share. The Exchange
also notes that with the deletion of this tier, Members will continue
to be subject to the other fees and tiers listed on the Exchange's fee
schedule, and routing through DE Route is voluntary. Lastly, the
Exchange also believes that the proposed amendment is non-
discriminatory because it applies uniformly to all Members.
    The rates associated with routing orders to NYSE through DE Route
on the Exchange's fee schedule are pass-through rates from DE Route to
the Exchange and represent an equitable allocation of reasonable dues,
fees, and other charges among Members of the Exchange and other persons
using its facilities because the Exchange does not levy additional fees
or offer additional rebates for orders that it routes to NYSE through
DE Route. The Exchange notes that routing through DE Route is
voluntary. Currently, for orders yielding Flag D, NYSE charges DE Route
a fee of $0.0023 per share, which, in turn, is passed through to the
Exchange. The Exchange, in turn, charges its Members a fee of $0.0023
per share as a pass-through. In NYSE's pricing changes for October 1,
2012, NYSE increased the rate it charges its customers, such as DE
Route, from $0.0023 per share to a charge of $0.0025 per share for
orders that are routed or re-routed to NYSE and remove liquidity.
Therefore, the Exchange believes that the proposed change for Flag D
from a fee of $0.0023 per share to a fee of $0.0025 per share is
equitable and reasonable because it accounts for the pricing changes on
NYSE. In addition, the proposal allows the Exchange to continue to
charge its Members a pass-through rate for orders that are routed or
re-routed to NYSE and remove liquidity using DE Route. Lastly, the
Exchange also believes that the proposed amendment is non-
discriminatory because it applies uniformly to all Members.
    The Exchange also notes that it operates in a highly-competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive. The proposed rule change reflects a competitive pricing
structure designed to incent market participants to direct their order
flow to the Exchange. The Exchange believes that the proposed rates are
equitable and non-discriminatory in that they apply uniformly to all
Members. The Exchange believes the fees and credits remain competitive
with those charged by other venues and therefore continue to be
reasonable and equitably allocated to Members.

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \12\ and Rule 19b-4(f)(2) \13\ thereunder. At
any time within 60 days of the filing of such proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 19b-4(f)(2).
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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-EDGA-2012-45 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-EDGA-2012-45. 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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGA-2012-45 and should be
submitted on or before November 1, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-24979 Filed 10-10-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 173 (Friday, September 4, 2020)]
[Notices]
[Pages 55303-55304]
[FR Doc No: 2020-19597]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0133]

Pharmacokinetics in Patients With Impaired Renal Function--Study
Design, Data Analysis, and Impact on Dosing; Draft Guidance for
Industry; Availability

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

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Pharmacokinetics in Patients with Impaired Renal Function--Study
Design, Data Analysis, and Impact on Dosing.'' In general, drug
development programs should be conducted so that when products are
approved, the labeling provides appropriate dosing recommendations for
patients with renal impairment. This draft guidance revises and
replaces the draft guidance entitled ``Pharmacokinetics in Patients
with Impaired Renal Function--Study Design, Data Analysis, and Impact
on Dosing and Labeling'' (March 2010) and is meant to assist sponsors
in the design and analysis of studies that assess the influence of
impaired renal function on the pharmacokinetics (PK) and/or
pharmacodynamics of an investigational drug and how such information
can impact dosing.

DATES: Submit either electronic or written comments on the draft
guidance by December 3, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-D-0133 for ``Pharmacokinetics in Patients with Impaired Renal
Function--Study Design, Data Analysis, and Impact on Dosing.'' 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 the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lauren Milligan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3159, Silver Spring, MD 20903-0002, 301-
796-5008, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Pharmacokinetics in Patients with Impaired Renal Function--
Study Design, Data Analysis, and Impact on Dosing.'' Drugs are
eliminated from the body by a variety of mechanisms. Most drugs are
cleared by a combination of some or all of the following pathways:
Metabolism and transport in the small intestine, metabolism and
transport in

the liver, and glomerular filtration and tubular secretion of unchanged
drug by the kidneys (i.e., renal excretion). If a drug is eliminated
primarily through renal excretion, then impaired renal function usually
alters the drug's PK to an extent that the dosage regimen may need to
be changed from that used in patients with normal renal function. For
most drugs that are likely to be administered to patients with impaired
renal function, it is important to characterize PK in subjects with
impaired renal function to provide appropriate dosing recommendations.
    The safety and efficacy of a drug are generally established for a
particular dosage regimen (or range of dosage regimens) in late-phase
clinical trials that enroll patients from the target patient
population. Frequently, however, individuals with advanced kidney
disease are explicitly excluded from participation in these studies,
hindering the assessment of the effects of severely impaired kidney
function on the PK of a drug or the patient's clinical response. A
well-planned drug development program can enable prospective dosage
adjustment based on the observed or expected changes in the PK of a
drug due to impaired renal function prior to initiating phase 2 or
phase 3 trials.
    This guidance replaces the 2010 version and provides updated
recommendations on the following topics:
    (1) When a dedicated study of a drug's PK in subjects with impaired
renal function is recommended and when it may not be needed;
    (2) The design and conduct of pharmacokinetic studies in subjects
with impaired renal function;
    (3) Considerations for characterizing a drug's PK in patients
undergoing intermittent or continuous dialytic therapies;
    (4) The use of pharmacokinetic information from phase 2 and 3
studies to inform dosing recommendations for patients with renal
impairment; and
    (5) The analysis and reporting of the results of studies that
characterize the impact of renal impairment and how these data inform
dosing.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Pharmacokinetics in Patients with Impaired Renal Function--Study
Design, Data Analysis, and Impact on Dosing.'' 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

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3521) is not required.
    However, this draft guidance refers to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA. The collection of information
in 21 CFR 201.57 has been approved under OMB control number 0910-0572.

III. Electronic Access

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

    Dated: August 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19597 Filed 9-3-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Rules and Regulations]
[Pages 81189-81191]
[FR Doc No: 2015-32734]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-1083]
RIN 1625-AA00

Safety Zone; Closure of Morro Bay Harbor Bar Entrance; Morro Bay,
CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard proposes to establish a temporary safety zone
in the navigable waters of the Morro Bay Harbor Entrance. This
temporary safety zone is being established to reduce significant
hazards subject to the vessels, the harbor, and the public during
periods of poor weather conditions. This proposed rulemaking would
prohibit persons and vessels from being in this temporary safety zone
unless specifically authorized by the Captain of the Port, Los
Angeles--Long Beach, or her designated representative.

DATES: This rule is effective without actual notice from December 29,
2015 February 29, 2016 11:59 p.m. For the purposes of enforcement,
actual notice will be used from 12:01 a.m. December 9, 2015, until
December 29, 2015. The safety zone will only be enforced when the COTP
or her designated representative deems it necessary because of
hazardous, breaking, or rough bar conditions.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2015-1803 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Jevon James, Waterways Management, U.S. Coast Guard
Sector Los Angeles--Long Beach; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive order
FR Federal Register
LLNR Light List Number
NPRM Notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard proposes to issue this temporary rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C.

553(b)(B), the Coast Guard finds that good cause exists for not
publishing a notice of proposed rulemaking (NPRM) with respect to this
rule.
    The bar located in Morro Bay, California, is unique to the Southern
California coastline. Throughout the year, the bar produces extremely
hazardous navigation conditions for all types of maritime traffic
within a small waterway. It is predicted that the Southern California
coast will be impacted by a strong El Ni[ntilde]o, in which abnormally
large waves will be observed. On December 7, 2015, a 53' commercial
fishing vessel requested to transit the bar during extremely hazardous
conditions, to include seas exceeding 20'. The COTP issued a COTP Order
to restrict the fishing vessel from crossing the bar until the weather
subsided, to prevent a potentially hazardous transit. Thus, waiting for
the publishing of the NPRM would be impracticable because immediate
action is needed to minimize potential danger to all vessels transiting
across the bar. For these reasons, the Coast Guard finds that good
cause exists for implementing this rule less than thirty days before
the effective date.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under the authority of 33
U.S.C. 1231. The Captain of the Port Los Angeles--Long Beach has
determined that a potential hazard exists during certain weather
conditions for all recreational and commercial vessels operating in the
vicinity of the Morro Bay Harbor Entrance. This temporary safety zone
is necessary to ensure the safety of, and reduce the risk to, the
persons and vessels that operate on and in the vicinity of the Morro
Bay Harbor Entrance.

IV. Discussion of the Rule

    The U.S. Coast Guard has established a temporary safety zone
encompassing all navigable waters near the inside and outside of the
mouth of the Morro Bay Harbor entrance, from December 9, 2015, to
February 29, 2016. When the Safety Zone is being enforced, the Coast
Guard will turn on the Morro Bay Rough Bar Warning Light (LLNR 3877;
35[deg]22.256' N., 120[deg]51.526 ' W.). This indicates that rough bar
conditions are taking place at the entrance. In addition, a Broadcast
Notice to Mariner will be used to inform mariners of the enforcement of
the safety zone. No vessel or person will be permitted to operate in
the safety zone without obtaining permission from the Captain of the
Port (COTP) or the COTP's designated representative. Sector Los
Angeles--Long Beach may be contacted on VHF-FM Channel 16 or 310-521-
3801.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders (E.O.s) related to rulemaking. Below we summarize our
analyses based on a number of these statutes and E.O.s, and we discuss
First Amendment rights of protestors.

A. Regulatory Planning and Review

    E.O.s 12866 and 13563 direct agencies to assess the costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a ``significant
regulatory action,'' under E.O. 12866. Accordingly, it has not been
reviewed by the Office of Management and Budget.
    The implementation of this temporary safety zone is necessary for
the protection of all waterway users. The size of the zone is the
minimum necessary to provide adequate protection for the waterways
users, adjoining areas, and the public. Any hardships experienced by
persons or vessels are considered minimal compared to the interest in
protecting the public.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule will affect the following entities, some of which may be
small entities: the owners or operators of vessels intending to transit
or anchor within the designated area during the designated enforcement
times. This temporary safety zone will not have a significant economic
impact on a substantial number of small entities for the following
reasons: (i) This zone will support the safety of vessel traffic
through the area, (ii) this zone is limited in scope and duration,
(iii) the Coast Guard will issue Broadcast Notice to Mariners via VHF-
FM marine channel 16 while the safety zone is enforced.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under E.O. 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in E.O. 13132.
    Also, this rule does not have tribal implications under E.O. 13175,
Consultation and Coordination with Indian Tribal Governments, because
it does 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. If you believe this rule has
implications for federalism or Indian tribes, please contact the person
listed in the FOR

FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded from further review under paragraph
34(g) of Figure 2-1 of the Commandant Instruction. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T11-750 to read as follows:

Sec.  165.T11-750  Safety Zone; Morro Bay Breaking Bar; Morro Bay
Harbor Entrance; Morro Bay, CA.

    (a) Location. The following area is a safety zone: All navigable
waters of the Morro Bay Harbor Entrance in approximate coordinates:
from a point on the shoreline at 35[deg]22.181' N. 120[deg]52.207' W.,
thence westward to 35[deg]22.181' N. 120[deg]52.538' W., thence
southward to 35[deg]21.367' N. 120[deg]52.538' W., thence eastward to a
point on the shoreline at 35[deg]21.366' N. 120[deg]51.717' W., thence
northward along the shoreline to a point inside the Morro Bay Harbor to
35[deg]22.153' N. 120[deg]51.698' W., thence northwestward to a point
on land at 35[deg]22.233' N. 120[deg]51.847' W., thence southward along
the shoreline to the beginning. These coordinates are based on North
American Datum of 1983.
    (b) Definitions. For the purposes of this section:
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, and local officer
designated by or assisting the Captain of the Port Los Angeles--Long
Beach (COTP) in the enforcement of the safety zone.
    Rough Bar means any swell, breaking surf, or wind conditions that
create safety hazards. This includes but is not limited to, breaking
surf 8 feet of greater or extreme steep or confused swell in the main
channel or in the judgment of the COTP or the COTP's designated
representative rough conditions exist.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, hail Coast Guard Station Morro Bay
on VHF-FM Channel 16 or call at<PHONE_NUMBER>. Those in the safety
zone must comply with all lawful orders or directions given to them by
the COTP or the COTP's designated representative.
    (d) Enforcement period. This rule is effective from 12:01 a.m.
December 9, 2015 until February 29, 2016 11:59 p.m. The safety zone
will only be enforced when the COTP or her designated representative
deems it necessary because of the rough bar conditions, and enforcement
will cease immediately upon conditions returning to safe levels.

    Dated: December 6, 2015.
J.F. Williams,
Captain, U.S. Coast Guard, Captain of the Port Los Angeles--Long Beach.
[FR Doc. 2015-32734 Filed 12-28-15; 8:45 am]
 BILLING CODE 9110-04-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 April 3, 2003 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL # 7001 1140 0001 4913 6709 Dear Registrant:

This is the Environmental Protection Agency's ( hereafter referred to as EPA or the Agency) Report of the Food Quality Protection Act ( FQPA) Tolerance Reassessment Progress and Risk Management Decision ( TRED) for 4 Chlorophenoxyacetic Acid ( 4 CPA), which was approved on April 3, 2003. A Notice of Availability of this TRED will be published in the Federal Register ( FR).

The Federal Food, Drug and Cosmetic Act ( FFDCA), as amended by FQPA, requires EPA to reassess all the tolerances for registered chemicals in effect on or before the date of the enactment of the FQPA, which was in August of 1996. In reassessing these tolerances, the Agency must consider, among other things, aggregate risks from non occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. Once a safety finding has been made that aggregate risks are not of concern, the tolerances are considered reassessed. A reregistration eligibility decision ( RED) for 4 CPA was completed in March 1995, prior to FQPA enactment. Therefore, the tolerances need to be reassessed to meet the FQPA standard.

The pesticide 4 CPA is used indoors to restrict root growth during seed germination of mung beans. The only exposure anticipated is via the food pathway. There is no exposure expected through consumption of drinking water given the enclosed nature of the chemical's use, and there are no registered residential uses. Therefore, aggregating exposures from the food, drinking water, and residential pathways of exposure is not necessary. As a result, the Agency has only evaluated the dietary ( food) risk associated with the use of 4 CPA, and has determined that there is a reasonable certainty that no harm to any population subgroup will result from this potential exposure. Therefore, no mitigation measures are needed, and the tolerances established for residues of 4 CPA in/ on raw agricultural commodities are now considered reassessed as safe under § 408( q) of the FFDCA.

FQPA requires that EPA consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity." The reason for considering other substances is because of the possibility that lowlevel exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect, as would a higher level of exposure to any of the other substances individually. 2 Although the Agency compared toxicities of other chlorophenoxy acetic acids to 4 CPA to improve the hazard characterization, EPA does not have, at this time, available data to determine whether 4 CPA has a common mechanism of toxicity with other substances. For the purposes of this TRED, EPA is assuming there is no common mechanism of toxicity, and that the tolerances established for residues of 4 CPA in/ on raw agricultural commodities are considered reassessed as safe under § 408( q) of the FFDCA.

The Agency also reviewed 4 CPA to determine if its use pattern could cause adverse impacts on endangered and threatened species. Approximately 20 pounds of 4 CPA active ingredient ( ai) are used per year for indoor treatment of mung beans at a single production facility. Due to the limited usage of this chemical in total annual pounds used and geographic area used, there are unlikely to be risks to endangered species associated with 4 CPA. Additionally, waste water discharges containing 4 CPA resulting from this registered use are subject to pre treatment requirements and are likely to be significantly diminished through this process. Any residues of 4 CPA leaving the production facility are likely to be further reduced ( if not eliminated) at a publicly owned treatment works prior to entering surface water. Therefore, EPA believes that the exposures and risks to endangered species from the registered use of 4 CPA are likely to be low and not of concern to the Agency.

The Agency's human health findings for the plant growth regulator 4 CPA are summarized in the enclosed human health risk assessment. The risk assessment and other technical support documents pertaining to the 4 CPA TRED are listed in Attachment One of this document and are available for viewing in the OPP public docket and on the Internet at http:// www. epa. gov/ edocket/. The 4 CPA docket ID number is OPP 2003 0124.

The tolerances for residues of 4 CPA in/ on raw agricultural commodities are for the parent compound, 4 CPA per se. No metabolites or degradates are included in the tolerance expression. The existing tolerances for 4 CPA have been reassessed. One tolerance for tomatoes ( no longer supported or on the label) will be revoked, and the tolerance for mung bean sprouts will be reduced from 2.0 to 0.2 ppm based upon previously reviewed and accepted residue chemistry studies. No maximum residue limits ( MRLs) for 4 CPA have been established or proposed by Codex. Therefore, there are no international compatibility issues with respect to the U. S. tolerances. A summary of the reassessed tolerances for residues of 4 CPA are found in Table 1.

Table 1. Tolerance Reassessment Summary for 4 CPA Commodity Established Tolerance ( ppm) Reassessed Tolerance ( ppm) Comments [ Correct Commodity Definition]

bean, mung, seed 2.0 0.2 Bean, mung, seed tomatoes 0.05 None Revoke, use deleted The food use subject to this TRED is listed in Table 2. The Agency has not identified any label amendments which should be implemented as a result of this TRED. 3 Table 2. Food/ Feed Use Patterns Subject to Tolerance Reassessment for 4 CPA Application a) Type b) Timing c) Equipment Formulation [ EPA Reg. No.] Application Rate Use Directions and Limitations beans, mung, seed a) immersion bath b) seedling germination c) water bath Soluble concentrate 96.2 % ai [ 8906 1] 7.4 X 10 4 lb ai / 100 lbs bean seeds Do not feed treated hulls or bean parts to livestock.

This letter summarizes the Agency's decision on the tolerance reassessment for 4 CPA. Please contact Mark Howard of my staff with any questions regarding this decision. He may be reached by phone at ( 703) 308 8172 or by e mail at howard. markt@ epa. gov.

Sincerely,

Lois A. Rossi, Director Special Review and Reregistration Division Enclosure: Human Health Risk Assessment for the 4 CPA TRED 4 Attachment One Technical Support Documents for the 4 CPA TRED 1. Anderson, Dave ( USEPA/ OPPTS/ OPP/ HED) Toxicity Studies with 4 Chlorophenoxyacetic acid ( 4 CPA) and Structures Related to 4 CPA. September 10, 2002.

2. Christensen, Carol ( USEPA/ OPPTS/ OPP/ HED) 4 Chlorophenoxyacetic acid. HED Human Health Risk Assessment for the Tolerance Reassessment Eligibility Document ( TRED). March 12, 2003.

3. Corbin, Mark ( USEPA/ OPPTS/ OPP/ EFED) 4 Chlorophenoxyacetic acid TRED. Estimated Drinking Water Concentrations for 4 CPA for use in the Human Health Risk Assessment. September 11, 2002.

4. Corbin, Mark ( USEPA/ OPPTS/ OPP/ EFED) 4 CPA B Evaluation of Endangered Species for the Tolerance Reassessment Decision ( TRED) Document for 4 CPA. Addendum to the September 11, 2002 EFED Drinking Water Concentrations. March 24, 2003


[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)]
[Rules and Regulations]
[Pages 59624-59627]
[FR Doc No: 2015-24851]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R03-OAR-2015-0029; FRL-9934-82-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Redesignation Request and Associated Maintenance Plan for
the Pittsburgh-Beaver Valley Nonattainment Area for the 1997 Annual and
2006 24-Hour Fine Particulate Matter Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving the
Commonwealth of Pennsylvania's request to redesignate to attainment the
Pittsburgh Nonattainment Area (Pittsburgh Area or Area) for the 1997
annual and 2006 24-hour fine particulate matter (PM2.5)
national ambient air quality standard (NAAQS or standard). EPA has
determined that the Pittsburgh Area attained both the 1997 annual and
2006 24-hour PM2.5 NAAQS. In addition, EPA is approving as a
revision to the Pennsylvania State Implementation Plan (SIP) the
associated maintenance plan to show maintenance of the 1997 annual and
2006 24-hour PM2.5 NAAQS through 2025 for the Pittsburgh
Area. The maintenance plan includes the 2017 and 2025 PM2.5
and nitrogen oxides (NOX) motor vehicle emissions budgets
(MVEBs) for the Pittsburgh Area for the 1997 annual and 2006 24-hour
PM2.5 NAAQS, which EPA is approving for transportation
conformity purposes. Furthermore, EPA is approving the 2007 emissions
inventories for the 1997 annual PM2.5 NAAQS and the 2011
emissions inventories for the 2006 24-hour PM2.5 NAAQS
included in the maintenance plan for the Pittsburgh Area. These actions
are being taken under the Clean Air Act (CAA).

DATES: This final rule is effective on October 2, 2015.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2015-0029. All documents in the docket are listed in
the 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 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: Rose Quinto at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On December 22, 2014, the Commonwealth of Pennsylvania, through the
Pennsylvania Department of Environmental Protection (PADEP), formally
submitted a request to redesignate the Pittsburgh Area from
nonattainment to attainment for the 1997 annual and 2006 24-hour
PM2.5 NAAQS. Concurrently, PADEP submitted a maintenance
plan for the Pittsburgh Area as a SIP revision to ensure continued
attainment throughout the Pittsburgh Area over the next 10 years. The
maintenance plan includes the 2017 and 2025 PM2.5 and
NOX MVEBs for the Area for the 1997 annual and 2006 24-hour
PM2.5 NAAQS, which EPA is approving for transportation
conformity purposes. PADEP also submitted 2007 and 2011comprehensive
emissions inventories that were included in the maintenance plan for
the 1997 annual and 2006 24-hour PM2.5 NAAQS, respectively,
for NOX, sulfur dioxide (SO2), volatile organic
compounds (VOC), and ammonia (NH3).
    On May 20, 2015 (80 FR 28906), EPA published a notice of proposed
rulemaking (NPR) for Pennsylvania. In the NPR, EPA proposed approval of
Pennsylvania's December 22, 2014 request to redesignate the Pittsburgh
Area to attainment for the 1997 annual and 2006 24-hour
PM2.5 NAAQS. EPA also proposed approval of the associated
maintenance plan as a revision to the Pennsylvania SIP for the 1997
annual and 2006 24-hour PM2.5 NAAQS, which includes the 2017
and 2025 PM2.5 and NOX MVEBs for both NAAQS,
which EPA proposed to approve for purposes of transportation
conformity. In addition, EPA proposed approval of the 2007 and 2011
emissions inventories included in the Pittsburgh Area's maintenance
plan for the 1997 annual and 2006 24-hour PM2.5 NAAQS,
respectively, to meet the emissions inventory requirement of section
172(c)(3) of the CAA.
    The details of Pennsylvania's submittal and the rationale for EPA's
proposed actions are explained in the NPR and will not be restated
here. No adverse public comments were received on the NPR.

II. Final Actions

    EPA is taking final actions on the redesignation request and SIP
revisions

submitted on December 22, 2014 by the Commonwealth of Pennsylvania for
the Pittsburgh Area for the 1997 annual and 2006 24-hour
PM2.5 NAAQS. First, EPA finds that the monitoring data
demonstrates that the Area has attained the 1997 annual and 2006 24-
hour PM2.5 NAAQS, and continues to attain both NAAQS.
Second, EPA is approving Pennsylvania's redesignation request for the
1997 annual and 2006 24-hour PM2.5 NAAQS, because EPA has
determined that the request meets the redesignation criteria set forth
in section 107(d)(3)(E) of the CAA for both NAAQS. Approval of this
redesignation request will change the official designation of the
Pittsburgh Area from nonattainment to attainment for the 1997 annual
and 2006 24-hour PM2.5 NAAQS. Third, EPA is approving the
associated maintenance plan for the Pittsburgh Area as a revision to
the Pennsylvania SIP for the 1997 annual and 2006 24-hour
PM2.5 NAAQS because it meets the requirements of section
175A of the CAA. The maintenance plan includes the 2017 and 2025
PM2.5 and NOX MVEBs submitted by Pennsylvania for
the Pittsburgh Area for transportation conformity purposes. In
addition, EPA is approving the 2007 and the 2011 emissions inventories
for the Pittsburgh Area as meeting the requirement of section 172(c)(3)
of the CAA for 1997 annual and 2006 24-hour PM2.5 NAAQS,
respectively.
    In accordance with 5 U.S.C. 553(d), EPA finds there is good cause
for this rulemaking action to become effective immediately upon
publication. A delayed effective date is unnecessary due to the nature
of a redesignation to attainment, which eliminates CAA obligations that
would otherwise apply. The immediate effective date for this rulemaking
action is authorized under both 5 U.S.C. 553(d)(1), which provides that
rulemaking actions may become effective less than 30 days after
publication if the rule ``grants or recognizes an exemption or relieves
a restriction,'' and section 553(d)(3), which allows an effective date
less than 30 days after publication ``as otherwise provided by the
agency for good cause found and published with the rule.'' The purpose
of the 30-day waiting period prescribed in section 553(d) is to give
affected parties a reasonable time to adjust their behavior and prepare
before the final rule takes effect. Today's rulemaking action, however,
does not create any new regulatory requirements such that affected
parties would need time to prepare before the rule takes effect.
Rather, today's rulemaking action relieves the Commonwealth of
Pennsylvania of the obligation to comply with nonattainment-related
planning requirements for the Pittsburgh Area pursuant to part D of the
CAA and approves certain emissions inventories and MVEBs for the
Pittsburgh Area. For these reasons, EPA finds good cause under 5 U.S.C.
553(d) for this rulemaking action to become effective on the date of
publication.

III. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of the maintenance plan under CAA section
107(d)(3)(E) are actions that affect the status of a geographical area
and do not impose any additional regulatory requirements on sources
beyond those required by state law. A redesignation to attainment does
not in and of itself impose any new requirements, but rather results in
the application of requirements contained in the CAA for areas that
have been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40
CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to
approve state choices, provided that they meet the criteria of the CAA.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this 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 rule 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.

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 action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action 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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by December 1, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action 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 request and
maintenance plan for the Pittsburgh Area for the 1997 annual and 2006
24-hour PM2.5 NAAQS and the comprehensive emissions
inventories for the Pittsburgh Area for the 1997

annual and the 2006 24-hour PM2.5 NAAQS, respectively, 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, Incorporation by
reference, Nitrogen oxides, Particulate matter, Reporting and
recordkeeping requirements, Sulfur dioxide, Volatile organic compounds.

40 CFR Part 81

    Air pollution control, National parks, Wilderness areas.

    Dated: September 17, 2015.
 Shawn M. Garvin,
Regional Administrator, Region III.

    40 CFR parts 52 and 81 are amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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 ``1997 Annual and 2006 24-Hour PM2.5
Maintenance Plan, and 2007 and 2011 Base Year Emissions Inventories''
at the end of the table. The added text reads as follows:

Sec.  52.2020  Identification of plan.

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

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

                                                  * * * * * * *
1997 Annual and 2006 24-Hour    Pittsburgh-Beaver        12/22/14  10/2/15 [Insert   See Sec.   52.2036(y) and
 PM2.5 Maintenance Plan, and     Valley.                            Federal           Sec.   52.2059(t).
 2007 and 2011 Base Year                                            Register
 Emissions Inventories.                                             citation].
----------------------------------------------------------------------------------------------------------------

0
3. Section 52.2036 is amended by adding paragraph (y) to read as
follows:

Sec.  52.2036  Base year emissions inventory.

* * * * *
    (y) EPA approves as a revision to the Pennsylvania State
Implementation Plan the 2007 and 2011 base year emissions inventories
for the Pittsburgh-Beaver Valley 1997 annual and 2006 24-hour fine
particulate matter (PM2.5) nonattainment area, respectively,
submitted by the Pennsylvania Department of Environmental Protection on
December 22, 2014. The emissions inventories include emissions
estimates that cover the general source categories of point, area,
nonroad, and onroad sources. The pollutants that comprise the
inventories are PM2.5, nitrogen oxides (NOX),
volatile organic compounds (VOCs), ammonia (NH3), and sulfur
dioxide (SO2).

0
4. Section 52.2059 is amended by adding paragraph (t) to read as
follows:

Sec.  52.2059  Control strategy: Particulate matter.

* * * * *
    (t) EPA approves the maintenance plan for the Pittsburgh
nonattainment area for the 1997 annual and 2006 24-hour
PM2.5 NAAQS submitted by the Commonwealth of Pennsylvania on
December 22, 2014. The maintenance plan includes the 2017 and 2025
PM2.5 and NOX motor vehicle emissions budgets
(MVEBs) to be applied to all future transportation conformity
determinations and analyses for the Pittsburgh nonattainment area for
the 1997 annual and 2006 24-hour PM2.5 NAAQS.

  Pittsburgh-Beaver Valley's Motor Vehicle Emission Budgets for the 1997 Annual and 2006 24-Hour PM2.5 NAAQS in
                                                  Tons per Year
----------------------------------------------------------------------------------------------------------------
  Type of control strategy SIP         Year            PM2.5            NOX       Effective date of SIP approval
----------------------------------------------------------------------------------------------------------------
Maintenance Plan................            2017             700          17,584  October 2, 2015.
                                            2025             537          10,709  October 2, 2015.
----------------------------------------------------------------------------------------------------------------

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
5. The authority citation for Part 81 continues to read as follows:

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

0
6. Section 81.339 is amended by revising the ``1997 Annual
PM2.5 NAAQS'' and the ``2006 24-Hour PM2.5
NAAQS'' tables entry for the Pittsburgh-Beaver Valley, PA to read as
follows:

Sec.  81.339  Pennsylvania.

* * * * *

                                      Pennsylvania--1997 Annual PM2.5 NAAQS
                                             [Primary and secondary]
----------------------------------------------------------------------------------------------------------------
                                                   Designation \a\                        Classification
          Designated area          -----------------------------------------------------------------------------
                                           Date \1\                 Type             Date \2\          Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Pittsburgh-Beaver Valley, PA:

    Allegheny County (remainder)..  October 2, 2015......  Attainment...........
    Armstrong County (part).......  October 2, 2015......  Attainment...........
Elderton Borough and Plumcreek and
 Washington Townships:
    Beaver County.................  October 2, 2015......  Attainment...........
    Butler County.................  October 2, 2015......  Attainment...........
    Greene County (part)..........  October 2, 2015......  Attainment...........
Monongahela Township:
    Lawrence County (part)........  October 2, 2015......  Attainment...........
Township of Taylor south of New
 Castle City:
    Washington County.............  October 2, 2015......  Attainment...........
    Westmoreland County...........  October 2, 2015......  Attainment...........

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after January 5, 2005, unless otherwise noted.
\2\ This date is July 2, 2014, unless otherwise noted.

* * * * *

                                     Pennsylvania--2006 24-Hour PM2.5 NAAQS
                                             [Primary and secondary]
----------------------------------------------------------------------------------------------------------------
                                                   Designation \a\                        Classification
          Designated area          -----------------------------------------------------------------------------
                                           Date \1\                 Type             Date \2\          Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Pittsburgh-Beaver Valley, PA:
    Allegheny County (remainder)..  October 2, 2015......  Attainment...........
    Armstrong County (part).......  October 2, 2015......  Attainment...........
Elderton Borough and Plumcreek and
 Washington Townships:
    Beaver County.................  October 2, 2015......  Attainment...........
    Butler County.................  October 2, 2015......  Attainment...........
    Green County (part)...........  October 2, 2015......  Attainment...........
Monongahela Township:
    Lawrence County (part)........  October 2, 2015......  Attainment...........
Township of Taylor south of New
 Castle City:
    Washington County.............  October 2, 2015......  Attainment...........
    Westmoreland County...........  October 2, 2015......  Attainment...........

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian County located in each county or area, except as otherwise specified.
\1\ This date is 30 days after November 13, 2009, unless otherwise noted.
\2\ This date is July 2, 2014, unless otherwise noted.

* * * * *
[FR Doc. 2015-24851 Filed 10-1-15; 8:45 am]
 BILLING CODE 6560-50-P


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

1. Agency/ Subagency originating request EPA, Office of Environmental Information 2. OMB control number b. G None A 2070  0093 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c.   Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a.   Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes   No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. G Three years from approval date b.   Other Specify: 01/ 31/ 08 7. Title Toxic Chemical Release Reporting ( Form R) ( Renewal)

8. Agency form number( s) ( If applicable) EPA ICR Number 1363.14, EPA form 9350 1 9. Keywords Environmental Protection, Community Right to Know, Reporting and Recordkeeping Requirements, Toxic Chemicals 10. Abstract This ICR extends approval to collect information under the Emergency Planning and Community Right to Know Act ( EPCAR) section 313 and section 6607 or the Pollution Prevention Act ( PPA) of 1990. Respondents submit information concerning toxic chemical releases into the air, land and water.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. X Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c.   Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 22,000 b. Total annual responses 82,000 ( rounded) 1. Percentage of these responses collected electronically 90% c. Total hours requested 3,746,590 d. Current OMB inventory 3,888,752 e. Difference  142,162 f. Explanation of difference 1. Program Change  48,491 2. Adjustment  93,671 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs __ 0_______________ b. Total annual costs ( O& M) _____________ 0_______________ c. Total annualized cost requested __________ 0_______________ d. Current OMB inventory _________________ 0_______________ e. Difference __________________ 0_______________ f. Explanation of difference 1. Program change _______________ 0_______________ 2. Adjustment ____________________ 0________________

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

17. Statistical methods Does this information collection employ statistical methods?

Q Yes   No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: __ Cassandra Vail_______________________ Phone: ____ 202 566 0753________________________

OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

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

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

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

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

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

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

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

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

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

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

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

Signature of Program Official Mike Flynn, Director Office of Information Analysis and Access Office of Environmental Information Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95