[Federal Register Volume 85, Number 164 (Monday, August 24, 2020)]
[Rules and Regulations]
[Pages 52043-52045]
[FR Doc No: 2020-18448]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0769; Product Identifier 2018-CE-033-AD; Amendment
39-21213; AD 2020-17-08]
RIN 2120-AA64

Airworthiness Directives; Pacific Aerospace Limited Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
Pacific Aerospace Limited Model 750XL airplanes with wing lightning
protection panels installed. This AD results from mandatory continuing
airworthiness information (MCAI) issued by the aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as
insufficient electrical bonding of the wing lightning protection
panels. The FAA is issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective September 14, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of September 14,
2020.
    The FAA must receive comments on this AD by October 8, 2020.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Pacific
Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton
3240, New Zealand; phone: +64 7843 6144; fax: +64 843 6134; email:
<EMAIL_ADDRESS>internet: www.aerospace.co.nz. You may view
this referenced service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the internet at https://www.regulations.gov by searching for locating Docket No. FAA-2020-0769.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0769; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aerospace Engineer, FAA,
General Aviation & Rotorcraft Section, International Validation Branch,
901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816)
329-4144; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The Civil Aviation Authority of New Zealand (CAA) has issued AD
DCA/750XL/21, dated December 15, 2017 (referred to after this as ``the
MCAI''), to correct an unsafe condition for Pacific Aerospace Limited
Model 750XL airplanes with wing lightning protection panels installed.
To accompany the MCAI, the CAA issued Notification of Airworthiness
Directive issued for New Zealand Aeronautical Products IAW ICAO Annex
8, dated December 15, 2017, which states:

    This [CAA] AD with effective date 22 December 2017 mandates an
electrical bonding inspection of the wing lightning protection
panels per the requirements in Pacific Aerospace Mandatory Service
Bulletin (MSB) PACSB/XL/092 issue 2, dated 15 December 2017, or
later approved revision.
    The [CAA] AD is prompted by the possibility that there may be
insufficient electrical bonding between the lightning protection
panels and the airframe.

    Due to a report of an airplane with wing lightning strike panels
that were not bonded to the airframe and without information confirming
whether the bonding was performed properly during the assembly process,
a check of all airplanes in operation is necessary.
    In addition to the inspection of the electrical bonding on the wing
lightning protection panels, the MCAI also requires repair of any
insufficient electrical bonding found during the inspection. You may
examine the MCAI on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-0769.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Pacific Aerospace Service Bulletin PACSB/XL/092,
Issue 2, dated December 15, 2017. The service information contains
procedures for inspecting the electrical bonding (verification testing)
on the wing lightning protection panels and repairing the electrical
bonding if insufficient bonding is found during the inspection. This
service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Differences Between This AD and the MCAI

    The MCAI requires compliance before further flight for aircraft
operating under instrument flight rules (IFR) and before February 15,
2018, for aircraft operating under visual flight rules. The FAA's
engineering assessment determined an emergency AD was not warranted.
Therefore, this AD requires compliance within 30 days for aircraft
approved to

operate under IFR and within 60 days for aircraft not approved to
operate under IFR.

FAA's Determination and Requirements of the AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, it has
notified the FAA of the unsafe condition described in the MCAI and
service information referenced above. The FAA is issuing this AD
because the agency evaluated all information provided by the State of
Design Authority and determined the unsafe condition exists and is
likely to exist or develop on other products of the same type design.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because if
not corrected the unsafe condition, in the event of a lightning strike,
could result in an inflight fire. The risk assessment received by the
FAA, and reconfirmed in July of 2020, indicates that urgent action is
required. The corrective actions necessary to mitigate this unsafe
condition must be accomplished within 30 days for IFR operation and 60
days for VFR operations. Therefore, the FAA finds good cause that
notice and opportunity for prior public comment are impracticable. In
addition, for the reasons stated above, the FAA finds that good cause
exists for making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, the FAA invites you to send any written data, views,
or arguments about this final rule. Send your comments to an address
listed under the ADDRESSES section. Include the Docket Number FAA-2020-
0769 and Product Identifier 2019-CE-033-AD at the beginning of your
comments. The FAA will consider all comments received by the closing
date and may amend this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The FAA will also post a report summarizing each substantive
verbal contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Mike
Kiesov, Aerospace Engineer, FAA, General Aviation & Rotorcraft Section,
International Validation Branch, 901 Locust, Room 301, Kansas City,
Missouri 64106. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Costs of Compliance

    The FAA estimates that this AD will affect 22 products of U.S.
registry. The FAA also estimates that it will take about 5 work-hours
per product to comply with the basic inspection requirements of this
AD. The average labor rate is $85 per work-hour.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $9,350, or $425 per product.
    In addition, the FAA estimates that any necessary follow-on repair
actions will take about 11 work-hours and require parts costing $200,
for a cost of $1,135 per product. The FAA has no way of determining the
number of products that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because FAA has determined
that it has good cause to adopt this rule without notice and comment,
RFA analysis is not required.

Regulatory Findings

    The FAA has determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2020-17-08 Pacific Aerospace Limited: Amendment 39-21213; Docket No.
FAA-2020-0769; Product Identifier 2018-CE-033-AD.

(a) Effective Date

    This AD becomes effective September 14, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pacific Aerospace Limited Model 750XL
airplanes, certificated in any category, with a wing lightning
protection panel installed.

(d) Subject

    Air Transport Association of America (ATA) Code 39: Electrical
Wiring.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as insufficient
electrical bonding of the wing lightning protection panels. The FAA
is issuing this AD to detect and correct insufficient electrical
bonding between the wing lightning protection panels and the
airframe that, in the event of a lightning strike in that area,
could result in an inflight fire.

 (f) Compliance

    Comply with the actions listed in paragraphs (g) and (h) of this
AD within the compliance times specified, unless already done.

(g) For Airplanes With Short Range Wings

    For airplanes approved for operation under instrument flight
rules (IFR), do the following actions within 30 days after September
14, 2020 (the effective date of this AD), and for airplanes not
approved for operation under IFR, do the following actions within 60
days after September 14, 2020 (the effective date of this AD):
    (1) Inspect each wing upper surface by following paragraphs
2.A.(1) through 2.A.(3) of the Accomplishment Instructions--Short
Range Wing in Pacific Aerospace Service Bulletin PACSB/XL/092, Issue
2, dated December 15, 2017 (PACSB/XL/092, Issue 2).
    (i) Using a mill-ohmmeter, determine the resistance between the
test point on each panel and the fuel cap.
    (ii) If the resistance is greater than 100 milliohms, before
further flight, repair the upper surface electrical bonding by
following paragraph 2.B. of the Accomplishment Instructions--Short
Range Wing in PACSB/XL/092, Issue 2.
    (2) Inspect each wing lower surface by following paragraphs
2.C.(1) through 2.C.(3) of the Accomplishment Instructions--Short
Range Wing in PACSB/XL/092, Issue 2.
    (i) Using a mill-ohmmeter, determine the resistance between each
test point and the airframe.
    (ii) If the resistance is greater than 100 milliohms, before
further flight, repair the lower surface electrical bonding by
following paragraph 2.D. of the Accomplishment Instructions--Short
Range Wing in PACSB/XL/092, Issue 2.

(h) For Airplanes With Extended Range Wings

    For airplanes approved for operation under IFR, do the following
actions within 30 days after September 14, 2020 (the effective date
of this AD), and for airplanes not approved for operation under IFR,
do the following actions within 60 days after September 14, 2020
(the effective date of this AD):
    (1) Inspect each wing upper surface by following paragraphs
3.A.(1) through 3.A.(3) of the Accomplishment Instructions--Extended
Range Wing in PACSB/XL/092, Issue 2.
    (i) Using a mill-ohmmeter, determine the resistance between the
test point on each panel and the fuel cap.
    (ii) If the resistance is greater than 100 milliohms, before
further flight, repair the upper surface electrical bonding by
following paragraph 3.B. of the Accomplishment Instructions--
Extended Range Wing in PACSB/XL/092, Issue 2.
    (2) Inspect each wing lower surface by following paragraphs
3.C.(1) through 3.C.(3) of the Accomplishment Instructions--Extended
Range Wing in PACSB/XL/092, Issue 2.
    (i) Using a mill-ohmmeter, determine the resistance between each
test point and the airframe.
    (ii) If the resistance is greater than 100 milliohms, before
further flight, repair the lower surface electrical bonding by
following paragraph 3.D. of the Accomplishment Instructions--
Extended Range Wing in PACSB/XL/092, Issue 2.

(i) Alternative Methods of Compliance

    The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Mike
Kiesov, Aerospace Engineer, FAA, General Aviation & Rotorcraft
Section, International Validation Branch, 901 Locust, Room 301,
Kansas City, Missouri 64106; telephone:<PHONE_NUMBER>; fax: (816)
329-4090; email<EMAIL_ADDRESS>Before using any approved AMOC
on any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.

 (j) Related Information

    Refer to MCAI Civil Aviation Authority of New Zealand AD DCA/
750XL/21, dated December 15, 2017, for related information. You may
examine the MCAI on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-0769.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Pacific Aerospace Service Bulletin PACSB/XL/092, Issue 2,
dated December 15, 2017.
    (ii) [Reserved].
    (3) For Pacific Aerospace service information identified in this
AD, contact Pacific Aerospace Limited, Airport Road, Hamilton,
Private Bag 3027, Hamilton 3240, New Zealand; phone: +64 7843 6144;
fax: +64 843 6134; email<EMAIL_ADDRESS>internet: https://www.aerospace.co.nz.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is
also available on the internet at https://www.regulations.gov by
searching for locating Docket No. FAA-2020-0769.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 12, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-18448 Filed 8-21-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 28, 2010 (Volume 75, Number 123)]
[Notices]
[Page 36762-36765]
[DOCID:fr28jn10-143]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62338; File No. SR-EDGA-2010-03]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing of Proposed Rule Change, as Modified by Amendment No. 1, To
Amend EDGA Rule 11.13, Entitled ``Clearly Erroneous Executions''

June 21, 2010.
    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 June 17, 2010, 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 Exchange. On June 18, 2010, the
Exchange submitted Amendment No. 1 to the proposed rule change. The
Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, 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 is proposing to amend EDGA Rule 11.13, entitled
``Clearly Erroneous Executions.''
    The text of the proposed rule change is available at the Exchange's
Web site at http://www.directedge.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 parts of such
statements.

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

1. Purpose
    The Exchange hereby submits this Amendment No. 1 to its rule
filing, SR-EDGA-2010-03, to replace and supersede the original filing
in its entirety.
    The Exchange is proposing modifications to its Rule 11.13, entitled
Clearly Erroneous Executions. First, the Exchange proposes replacing
existing paragraph (c)(2) of Rule 11.13, entitled ``Unusual
Circumstances and Joint Market Rulings'' with a new paragraph, entitled
``Multi-Stock Events Involving Twenty or More Securities.'' Second, the
Exchange is proposing to replace existing paragraph (c)(4) of Rule
11.13, entitled ``Numerical Guidelines Applicable to Volatile Market
Opens'' with a new paragraph, entitled ``Individual Stock Trading
Pauses.'' Third, the Exchange is proposing changes to existing
paragraphs (f) and (g) of Rule 11.13 to eliminate the ability of the
Exchange to deviate from the Numerical Guidelines contained in
paragraph (c)(1) (other than under limited circumstances set forth in
paragraph (f)) when deciding which transactions will be reviewed by the
Exchange as potentially clearly erroneous. Finally, the Exchange
proposes modifications to paragraphs (c)(1), (c)(3) and (e) of Rule
11.13 consistent with the proposed changes to paragraphs (c)(2) and
(c)(4). As proposed, the provisions of paragraphs (c), (e)(2), (f), and
(g) of Rule 11.13, as amended pursuant to this filing, would be in
effect during a pilot period set to end on December 10, 2010. If the
pilot is not either extended or approved permanent by December 10,
2010, the prior versions of paragraphs (c), (e)(2), (f), and (g) of
Rule 11.13 would be in effect.
    The Exchange is proposing the rule changes described below in
consultation with other markets and Commission staff to provide for
uniform treatment: (1) Of clearly erroneous execution reviews in Multi-
Stock Events involving twenty or more securities; and (2) in the event
transactions occur that result in the issuance of an individual stock
trading pause by the primary market and subsequent transactions that
occur before the trading pause is in effect on the Exchange. The
Exchange has also proposed additional changes to Rule 11.13 that reduce
the ability of the Exchange to deviate from the objective standards set
forth in the Rule. The proposed changes are described in further detail
below.

Revised Paragraph (c)(2) Related to Multi-Stock Events Involving Twenty
or More Securities

    The Exchange proposes to eliminate the majority of existing
paragraph (c)(2), which provides flexibility to the Exchange to use
different Numerical Guidelines or Reference Prices in various ``Unusual
Circumstances.'' The Exchange proposes to replace this paragraph with
new language that would apply to Multi-Stock Events involving twenty or
more securities whose executions occurred within a period of five
minutes or less. The revised paragraph would retain language making
clear that during Multi-Stock Events involving twenty or more
securities the number of affected transactions may be such that
immediate finality is necessary to maintain a fair and orderly market
and to protect investors and the public

interest. Accordingly, in such circumstances, decisions made by the
Exchange in consultation with other markets could not be appealed.
Further, as proposed, in connection with reviews of Multi-Stock Events
involving twenty or more securities, the Exchange may use a Reference
Price other than consolidated last sale in its review of potentially
clearly erroneous executions. With the exception of those securities
under review that are subject to an individual stock trading pause as
described in proposed paragraph (c)(4), and to ensure consistent
application across market centers when proposed paragraph (c)(2) is
invoked, the Exchange will promptly coordinate with the other market
centers to determine the appropriate review period, which may be
greater than the period of five minutes or less that triggered
application of proposed paragraph (c)(2), as well as select one or more
specific points in time prior to the transactions in question and use
transaction prices at or immediately prior to the one or more specific
points in time selected as the Reference Price. The Exchange will
nullify as clearly erroneous all transactions that are at prices equal
to or greater than 30% away from the Reference Price in each affected
security during the review period selected by the Exchange and other
markets consistent with the proposed paragraph (c)(2).
    Because the Exchange and other market centers are adopting a
different threshold and standards to handle large-scale market events,
which would include events occurring during times of high volatility at
the beginning of regular trading hours, the Exchange proposes deletion
of paragraph (c)(4) (``Numerical Guidelines Applicable to Volatile
Market Opens'') of the existing rule. The Exchange believes that this
provision is no longer necessary, and if maintained, could result in
extremely high Numerical Guidelines (up to 90%) in certain
circumstances.

Revised Paragraph (c)(4) Related to Individual Stock Trading Pauses

    The primary listing markets for U.S. stocks recently amended their
rules so that they may, from time to time, issue a trading pause for an
individual security if the price of such security moves 10% or more
from a sale in a preceding five-minute period. In this regard, the
Exchange recently amended its rules to pause trading in an individual
stock when the primary listing market for such stock issues a trading
pause in any Circuit Breaker Securities, as defined in Interpretation
and Policy .05 of Rule 11.14.\3\ As described above, the Exchange is
proposing to eliminate existing paragraph (c)(4) (``Numerical
Guidelines Applicable to Volatile Market Opens''). The Exchange
proposes adopting a rule, numbered as (c)(4) following such
elimination, which will provide for uniform treatment of clearly
erroneous execution reviews in the event transactions occur that result
in the issuance of an individual stock trading pause by the primary
listing market and subsequent transactions that occur before the
trading pause is in effect on the Exchange. The proposed rule change is
necessary to provide greater certainty of the clearly erroneous
Reference Price for transactions that trigger a trading pause (the
``Trigger Trade'') and subsequent transactions occurring between the
time of the Trigger Trade and the time the trading pause message is
received by the Exchange from the single plan processor responsible for
consolidation and dissemination of information for the security and put
into effect on the Exchange, especially under highly volatile and
active market conditions.
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    \3\ See EDGA Rule 11.14; see also Securities Exchange Act
Release No. 62252 (June 10, 2010), 75 FR 34186 (June 16, 2010) (SR-
EDGA-2010-01).
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    The Exchange proposes to revise paragraph (c)(4) of EDGA Rule 11.13
to allow the Exchange to use the price that triggered a trading pause
in an individual stock (the ``Trading Pause Trigger Price'') as the
Reference Price for clearly erroneous execution reviews of a Trigger
Trade and transactions that occur immediately after a Trigger Trade but
before a trading pause is in effect on the Exchange. As proposed, the
phrase ``Trading Pause Trigger Price'' shall mean the price that
triggered a trading pause in any Circuit Breaker Securities as defined
in Interpretation and Policy .05 of Rule 11.14. The Trading Pause
Trigger Price reflects a price calculated by the primary listing market
over a rolling five-minute period and may differ from the execution
price of a transaction that triggered a trading pause. The Exchange
will rely on the primary listing market that issued an individual stock
trading pause to determine and communicate the Trading Pause Trigger
Price for such stock. The Exchange proposes to make clear in the text
that the proposed standards in paragraph (c)(4) apply regardless of
whether the security at issue is part of a Multi-Stock Event involving
five or more securities as described in proposed paragraphs (c)(1) and
(c)(2).
    As proposed, the Numerical Guidelines set forth in EDGA Rule
11.13(c)(1), other than those Numerical Guidelines applicable to Multi-
Stock Events, would apply to reviews of Trigger Trades and subsequent
transactions. The Exchange proposes to review, on its own motion
pursuant to paragraph (g) of the Rule, all transactions that trigger a
trading pause and subsequent transactions occurring before the trading
pause is in effect on the Exchange. The Exchange has proposed to limit
such reviews to reviews of transactions that executed at a price lower
than the Trading Pause Trigger Price in the event of a price decline
and higher than the Trading Pause Trigger Price in the event of a price
rise. Because the proposed rules for trading pauses would only apply
within Regular Trading Hours,\4\ an execution would be reviewed and
nullified as clearly erroneous if it exceeds the following thresholds:
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    \4\ Regular Trading Hours are defined in EDGA Rule 1.5 as the
time between 9:30 a.m. and 4 p.m. Eastern Time. According to rules
of the primary listing markets, an individual stock trading pause
can be issued based on a Trigger Trade that occurs at any time
between 9:45 a.m. and 3:35 p.m. Eastern Time. See NASDAQ Rule
4120(a)(11), NYSE Rule 80C, and NYSE Arca Rule 7.11.

------------------------------------------------------------------------
                                          Numerical guidelines (subject
                                            transaction's % difference
       Reference price or product         from the trading pause trigger
                                                      price)
------------------------------------------------------------------------
Greater than $0.00 up to and including   10
 $25.00.
Greater than $25.00 up to and including  5
 $50.00.
Greater than $50.00....................  3
Leveraged ETF/ETN securities...........  Regular Trading Hours Numerical
                                          Guidelines multiplied by the
                                          leverage multiplier (i.e.,
                                          2x).
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Revisions to Paragraphs (f) and (g)

    Consistent with other proposals made in this filing, the Exchange
proposes modifying paragraphs (f) and (g) to eliminate the ability of
an Exchange official to deviate from the Numerical Guidelines contained
in the Rule other than under very limited circumstances set forth in
paragraph (f).
    Current paragraph (f) provides an Officer of the Exchange or other
senior level employee designee the ability on his or her own motion, to
review and rule on executions that result from ``any disruption or a
malfunction in the use or operation of any electronic communications
and trading facilities of the Exchange, or extraordinary market
conditions or other circumstances in which the nullification of
transactions may be necessary for the maintenance of a fair and orderly
market or the protection of investors and the public interest exist.''
Without modification, the language ``extraordinary market conditions or
other circumstances * * *'' would leave the Exchange with broad
discretion to deviate from the Numerical Guidelines set forth in
paragraph (c)(1). Thus, the Exchange proposes narrowing the scope of
paragraph (f) so that it only permits the Exchange to nullify
transactions consistent with that paragraph (including at a lower
Numerical Guideline) if there is a disruption or malfunction in the
operation of the Exchange's system. For the same reason, the Exchange
proposes eliminating the words ``use or'' from the language in
paragraph (f) to make clear that the provision only applies to a
disruption or malfunction of the Exchange's system (and not of an
Exchange user's systems).
    Paragraph (g) gives an Officer of the Exchange or other senior
level employee designee the ability on his or her own motion to review
transactions as potentially clearly erroneous. Consistent with the goal
of achieving more objective and standard results, the Exchange proposes
deleting language in existing paragraph (g) that would allow the
Exchange to deviate from the Numerical Guidelines contained in
paragraph (c)(1). In addition, the Exchange proposes to make clear that
any Officer of the Exchange or other senior level employee reviewing
transactions on his or her own motion must follow the guidelines set
forth in proposed paragraph (c)(4), if applicable. Accordingly, the
Exchange proposes to modify paragraph (g) to state that an Officer must
rely on paragraphs (c)(1)-(4) of Rule 11.13 when reviewing transactions
on his or her own motion.

Additional Conforming Revisions to Paragraphs (c)(1), (c)(3), and (e)

    Based on proposed paragraph (c)(2), the Exchange has proposed
certain conforming changes to paragraphs (c)(1), (c)(3), and (e) of the
existing Rule, as described below.
    Under current EDGA Rule 11.13, a transaction may be found to be
clearly erroneous only if the price of the transaction to buy (sell)
that is the subject of the complaint is greater than (less than) the
Reference Price by an amount that equals or exceeds the Numerical
Guidelines set forth in paragraph (c)(1) of the Rule. The ``Reference
Price'' is currently defined as ``the consolidated last sale
immediately prior to the execution(s) under review except for in
Unusual Circumstances as described in paragraph (c)(2)'' of EDGA Rule
11.13. The Exchange proposes modifying paragraph (c)(1) consistent with
the changes described above such that the Exchange shall use the
consolidated last sale immediately prior to the execution(s) under
review as the Reference Price except for: (A) Multi-Stock Events
involving twenty or more securities, as described in proposed paragraph
(c)(2); (B) transactions not involving a Multi-Stock Event as described
in proposed paragraph (c)(2) that trigger a trading pause and
subsequent transactions, as described in proposed paragraph (c)(4), in
which case the Reference Price shall be determined in accordance with
that paragraph (c)(4); and (C) in other circumstances, such as, for
example, relevant news impacting a security or securities, periods of
extreme market volatility, sustained illiquidity, or widespread system
issues, where use of a different Reference Price is necessary for the
maintenance of a fair and orderly market and the protection of
investors and the public interest. The Exchange also proposes modifying
paragraph (c)(1) to reduce uncertainty as to the applicability of the
Numerical Guidelines, by requiring a finding that an execution was
clearly erroneous if such execution exceeds the Numerical Guidelines,
subject only to the Additional Factors included in paragraph (c)(3).
Moreover, the Exchange proposes revising the existing description for
Multi-Stock Events that is contained on the Numerical Guidelines chart
to make clear that different Numerical Guidelines apply for Multi-Stock
Events involving five or more, but less than twenty, securities whose
executions occurred within a period of five minutes or less. In
addition, the Exchange proposes adding to the Numerical Guidelines
chart a row that contains the Numerical Guidelines (30%) for Multi-
Stock Events involving twenty or more securities whose executions
occurred within a period of five minutes or less.
    The Exchange proposes clarifying paragraph (c)(3) to make clear
that the additional factors set forth in that paragraph are not
intended to provide any discretion to an Exchange official to deviate
from the guidelines that apply to Multi-Stock Events or to transactions
in securities subject to individual stock trading pauses.
    Finally, the Exchange proposes amending paragraph (e)(2), related
to appeals of clearly erroneous execution decisions by the Exchange, to
preserve non-appealability of all joint rulings between the Exchange
and one or more other market centers. The Exchange believes that
certainty and consistency is critical to reviews of related executions
that span multiple market centers. Accordingly, although the Exchange
has proposed deletion of such language from existing paragraph (c)(3),
the Exchange proposes adding such language back in to paragraph (e)(2)
to make clear that joint market rulings are not appealable.
2. Statutory Basis
    Approval of the rule change proposed in this submission is
consistent with the requirements of the Act and the rules and
regulations thereunder that are applicable to a national securities
exchange, and, in particular, with the requirements of Section 6(b) of
the Act.\5\ In particular, the proposed change is consistent with
Section 6(b)(5) of the Act,\6\ because it would promote just and
equitable principles of trade, remove impediments to, and perfect the
mechanism of, a free and open market and a national market system, and,
in general, protect investors and the public interest. The proposed
rule change is also designed to support the principles of Section
11A(a)(1) \7\ of the Act in that it seeks to assure fair competition
among brokers and dealers and among exchange markets. The Exchange
believes that the proposed rule meets these requirements in that it
promotes transparency and uniformity across markets concerning reviews
of potentially clearly erroneous executions in various contexts,
including reviews in the context of a Multi-Stock Event involving
twenty or more securities and reviews resulting from a Trigger Trade
and any executions occurring immediately after a Trigger Trade but

before a trading pause is in effect on the Exchange. Further, the
Exchange believes that the proposed changes enhance the objectivity of
decisions made by the Exchange with respect to clearly erroneous
executions.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change imposes
any burden on competition.

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

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

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve such proposed rule change, or
    B. Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-EDGA-2010-03 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-2010-03. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such 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 publicly available. All
submissions should refer to File Number SR-EDGA-2010-03 and should be
submitted on or before July 19, 2010.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-15545 Filed 6-25-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register: February 22, 2008 (Volume 73, Number 36)]
[Notices]
[Page 9793-9794]
[DOCID:fr22fe08-58]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R10-OAR-2007-0411; FRL-8531-5]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Federal Implementation Plans
Under the Clean Air Act for Indian Reservations in Idaho, Oregon, and
Washington (Renewal); EPA ICR No. 2020.03, OMB Control No. 2060-0558

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before March 24,
2008.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-R10-OAR-
2007-0411, to (1) EPA online using www.regulations.gov (our preferred
method), by e-mail to<EMAIL_ADDRESS>or by mail to: Debra
Suzuki, Environmental Protection Agency Region 10, Office of Air, Waste
and Toxics (AWT-107), 1200 Sixth Avenue, Suite 900, Seattle, WA, 98101;
and (2) OMB by mail to: Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB), Attention: Desk Officer for EPA,
725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Debra Suzuki, Office of Air, Waste and
Toxics (AWT-107), Environmental Protection Agency Region 10, 1200 Sixth
Avenue, Suite 900, Seattle, WA, 98101; telephone number: (206) 553-
0985; fax number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 24, 2007 (72 FR 29161), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-R10-OAR-2007-0411, which is available for online viewing at
www.regulations.gov, or in person viewing during normal business hours
at Environmental Protection Agency Region 10, Office of Air, Waste and
Toxics (AWT-107), 1200 Sixth Avenue, Seattle, WA.
    Use EPA's electronic docket and comment system at
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at www.regulations.gov as EPA receives
them and without change, unless the comment contains copyrighted
material, confidential business information (CBI), or other information
whose public disclosure is restricted by statute. For further
information about the electronic docket, go to www.regulations.gov.
    Title: Federal Implementation Plans under the Clean Air Act for
Indian Reservations in Idaho, Oregon, and Washington (Renewal).
    ICR number: EPA ICR No. 2020.03, OMB Control No. 2060-0558.
    ICR status: This ICR is scheduled to expire on February 29, 2008.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An 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. The OMB control numbers for EPA's regulations
in title 40 of the CFR,

after appearing in the Federal Register when approved, are listed in 40
CFR part 9, are displayed either by publication in the Federal Register
or by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
in certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: EPA promulgated Federal Implementation Plans (FIPs) under
the Clean Air Act for Indian reservations located in Idaho, Oregon, and
Washington in 40 CFR part 49 (70 FR 18074, April 8, 2005). The FIPs in
the final rule, also referred to as the Federal Air Rules for Indian
Reservations in Idaho, Oregon, and Washington (FARR), include
information collection requirements associated with the partial
delegation of administrative authority to a Tribe rule in Sec.  49.122;
the visible emissions rule in Sec.  49.124; the fugitive particulate
matter rule in Sec.  49.126; the woodwaste burners rule in Sec.
49.127; the rule for limiting sulfur in fuels in Sec.  49.130; the rule
for open burning in Sec.  49.131; the rules for general open burning
permits, agricultural burning permits, and forestry and silvicultural
burning permits in Sec. Sec.  49.132, 49.133, and 49.134; the emissions
detrimental to human health or welfare rule in Sec.  49.135; the
registration rule in Sec.  49.138; and the rule for non-Title V
operating permits in Sec.  49.139. EPA uses this information to manage
the activities and sources of air pollution on the Indian reservations
in Idaho, Oregon, and Washington. EPA believes these information
collection requirements are appropriate because they will enable EPA to
develop and maintain accurate records of air pollution sources and
their emissions, track emissions trends and changes, identify potential
air quality problems, allow EPA to issue permits or approvals, and
ensure appropriate records are available to verify compliance with
these FIPs. The information collection requirements listed above are
all mandatory. Regulated entities can assert claims of business
confidentiality and EPA would treat these claims in accordance with the
provisions of 40 CFR part 2, subpart B.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to be 4,289
hours, or an average of approximately 2 hours per response. Burden
means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide
information to or for a Federal agency. This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements
which have subsequently changed; train personnel to be able to respond
to a collection of information; search data sources; complete and
review the collection of information; and transmit or otherwise
disclose the information.
    Affected Entities: Entities potentially affected by this action
include owners and operators of emission sources in all industry groups
and tribal, federal, and local governments, located on the identified
Indian reservations.
    Estimated Number of Respondents: 1,722.
    Frequency of Response: Annual and on occasion.
    Estimated Total Annual Hour Burden: 4,289.
    Estimated Total Annual Cost: $245,815. This includes an estimated
labor cost of $245,815, and no capital investment or operation and
maintenance costs.
    Changes in the Estimates: There is an increase of 1,512 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This increase is due to adjustments to the
estimates. Several components of the burden estimates increased and
several components decreased. In some cases, the burden estimates
increased based on input from the source consultations. In other cases,
the burden estimates decreased because EPA's original estimates
included many ``one-time'' or initial costs (e.g., time spent gaining
familiarity with the applicable rules, initial registration, etc.) that
are not expected to be recurring. The original estimates did not
include estimates for one provision, which accounts for some of the
increase in estimated burden. For some provisions, the estimates of the
number of respondents increased, while other estimates decreased based
on additional information EPA has gained about the source universe
through implementing the rules.

    Dated: February 14, 2008.
Richard T. Westlund,
Acting Director, Collection Strategies Division.
[FR Doc. E8-3372 Filed 2-21-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: March 31, 2010 (Volume 75, Number 61)]
[Notices]
[Page 16104-16105]
[DOCID:fr31mr10-68]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0167; FRL-8811-4]

Bromine Registration Review Final Decision; Notice of
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's final
registration review decision for the pesticide Bromine, case 4015.
Registration review is EPA's periodic review of pesticide registrations
to ensure that each pesticide continues to satisfy the statutory
standard for registration, that is, that the pesticide can perform its
intended function without causing unreasonable adverse effects on human
health or the environment. Through this program, EPA is ensuring that
each pesticide's registration is based on current scientific and other
knowledge, including its effects on human health and the environment.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information,
contact: K. Avivah Jakob, Antimicrobials Division (7510P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>    For general information on the registration review program,
contact: Lance Wormell, Antimicrobials Division (7510P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; e-mail address: wormell.lance @epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the pesticide specific contact person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0167. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. Background

A. What Action is the Agency Taking?

    Pursuant to 40 CFR 155.58(c), this notice announces the
availability of EPA's final registration review decision for bromine,
case 4015. Bromine is a bromide releasing antimicrobial pesticide that
is registered as a mildewstat/mildewcide, bactericide, fungistate,
fungicide, virucide, and insecticide. Bromine is registered for use to
control bacteria and fungi on surfaces of agricultural, commercial,
institutional, industrial, residential, and public access premises and
equipment. It is also registered for use to treat/disinfect potable
water (examples of potable water system treatment sites include, but
are not restricted to, aboard ships and on oil and gas drilling/
production platforms).
    Pursuant to 40 CFR 155.57, a registration review decision is the
Agency's determination whether a pesticide meets, or does not meet, the
standard for registration in FIFRA. EPA has considered bromine in light
of the FIFRA standard for registration. The Final Decision document in
the docket describes the Agency's rationale for issuing a registration
review final decision for this pesticide.
    In addition to the final registration review decision document, the
registration review docket for bromine also includes other relevant
documents related to the registration review of this case. The combined
final work plan and proposed registration review decision was posted to
the docket and the public was invited to submit any comments or new
information. During the 60-day comment period, no public comments were
received.
    Pursuant to 40 CFR 155.58(c), the registration review case docket
for bromine will remain open until all actions required in the final
decision have been completed.
    Background on the registration review program is provided at:
http://www.epa.gov/oppsrrd1/registration_review. Links to earlier
documents related to the registration review of this pesticide are
provided at: http://www.epa.gov/oppsrrd1/registration_review/bromine/
index.htm .

B. What is the Agency's Authority for Taking this Action?

    Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide
authority for this action.

List of Subjects

    Environmental protection, Registration review, Pesticides and
pests, Antimicrobials, Bromine.

    Dated: February 3, 2010.
Joan Harrigan Farrelly.
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. 2010-7045 Filed 3-30-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16393-16395]
[FR Doc No: 2015-07008]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0114]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Request for Samples and Protocols

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements relating to the regulations which state that protocols for
samples of biological products must be submitted to the Agency.

DATES: Submit either electronic or written comments on the collection
of information by May 26, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.

    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Request for Samples and Protocols--(OMB Control Number 0910-0206)--
Extension

    Under section 351 of the Public Health Service Act (42 U.S.C. 262),
FDA has the responsibility to issue regulations that prescribe
standards designed to ensure the safety, purity, and potency of
biological products and to ensure that the biologics licenses for such
products are only issued when a product meets the prescribed standards.
Under 21 CFR 610.2, the Center for Biologics Evaluation and Research
(CBER) or the Center for Drugs Evaluation and Research may at any time
require manufacturers of licensed biological products to submit to FDA
samples of any lot along with the protocols showing the results of
applicable tests prior to distributing the lot of the product. In
addition to Sec.  610.2, there are other regulations that require the
submission of samples and protocols for specific licensed biological
products: 21 CFR 660.6 (Antibody to Hepatitis B Surface Antigen); 21
CFR 660.36 (Reagent Red Blood Cells); and 21 CFR 660.46 (Hepatitis B
Surface Antigen).
    Section 660.6(a) provides requirements for the frequency of
submission of samples from each lot of Antibody to Hepatitis B Surface
Antigen product, and Sec.  660.6(b) provides the requirements for the
submission of a protocol containing specific information along with
each required sample. For Sec.  660.6 products subject to official
release by FDA, one sample from each filling of each lot is required to
be submitted along with a protocol consisting of a summary of the
history of manufacture of the product, including all results of each
test for which test results are requested by CBER. After official
release is no longer required, one sample along with a protocol is
required to be submitted at 90-day intervals. In addition, samples,
which must be accompanied by a protocol, may at any time be required to
be submitted to CBER if continued evaluation is deemed necessary.
    Section 660.36(a) requires, after each routine establishment
inspection by FDA, the submission of samples from a lot of final
Reagent Red Blood Cell product along with a protocol containing
specific information. Section 660.36(a)(2) requires that a protocol
contain information including, but not limited to, manufacturing
records, certain test records, and identity test results. Section
660.36(b) requires a copy of the antigenic constitution matrix
specifying the antigens present or absent to be submitted to the CBER
Director at the time of initial distribution of each lot.
    Section 660.46(a) contains requirements as to the frequency of
submission of samples from each lot of Hepatitis B Surface Antigen
product, and Sec.  660.46(b) contains the requirements as to the
submission of a protocol containing specific information along with
each required sample. For Sec.  660.46 products subject to official
release by FDA, one sample from each filling of each lot is required to
be submitted along with a protocol consisting of a summary of the
history of manufacture of the product, including all results of each
test for which test results are requested by CBER. After notification
of official release is received, one sample along with a protocol is
required to be submitted at 90-day intervals. In addition, samples,
which must be accompanied by a protocol, may at any time be required to
be submitted to CBER if continued evaluation is deemed necessary.
    Samples and protocols are required by FDA to help ensure the
safety, purity, or potency of a product because of the potential lot-
to-lot variability of a product produced from living organisms. In
cases of certain biological products (e.g., Albumin, Plasma Protein
Fraction, and therapeutic biological products) that are known to have
lot-to-lot consistency, official lot release is not normally required.
However, submissions of samples and protocols of these products may
still be required for surveillance, licensing, and export purposes, or
in the event that FDA obtains information that the manufacturing
process may not result in consistent quality of the product.
    The following burden estimate is for the protocols required to be
submitted with each sample. The collection of samples is not a
collection of information under 5 CFR 1320.3(h)(2). Respondents to the
collection of information under Sec.  610.2 are manufacturers of
licensed biological products. Respondents to the collection of
information under Sec. Sec.  660.6(b), 660.36(a)(2) and (b), and
660.46(b) are manufacturers of the specific products referenced
previously in this document. The estimated number of respondents for
each regulation is based on the annual number of manufacturers that
submitted samples and protocols for biological products including
submissions for lot release, surveillance, licensing, or export. Based
on information obtained from FDA's database system, approximately 80
manufacturers submitted samples and protocols in fiscal year (FY) 2014,
under the regulations cited previously in this document. FDA estimates
that approximately 76 manufacturers submitted protocols under Sec.
610.2 and 2 manufacturers submitted protocols under the regulation
(Sec.  660.6) for the other specific product. FDA received no
submissions under Sec.  660.36 or Sec.  660.46, however FDA is using
the estimate of one protocol submission under each regulation in the
event that protocols are submitted in the future.
    The estimated total annual responses are based on FDA's final
actions completed in FY 2014 for the various submission requirements of
samples and protocols for the licensed biological products. The average
burden per response is based on information provided by industry. The
burden estimates provided by industry ranged from 1 to 5.5 hours. Under
Sec.  610.2, the average burden per response is based on the average of
these estimates and rounded to 3 hours. Under the remaining
regulations, the average burden per response is based on the higher end
of the estimate (rounded to 5 or 6 hours) since more information is
generally required to be submitted in the other protocols than under
Sec.  610.2. FDA estimates the burden of this information collection as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                              Number of       Total       Average
               21 CFR section                  Number of    responses per     annual     burden per  Total hours
                                              respondents    respondent     responses     response
----------------------------------------------------------------------------------------------------------------
610.2 Lot Release Information Submission....           76           84.54        6,197            3       18,591
660.6(b) Lot Release Information Submission.            2            9              18            5           90
660.36(a)(2) and (b) Lot Release Information            1            1               1            6            6
 Submission.................................
660.46(b) Lot Release Information Submission            1            1               1            5            5
                                             -------------------------------------------------------------------
    Total...................................           80  ..............        6,217  ...........       18,692
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: March 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07008 Filed 3-26-15; 8:45 am]
 BILLING CODE 4164-01-P