[Federal Register Volume 78, Number 163 (Thursday, August 22, 2013)]
[Notices]
[Pages 52201-52202]
[FR Doc No: 2013-20469]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0871]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Studies
on Consumer Responses to Nutrient Content Claims on Fortified Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
September 23, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-New and
title ``Experimental Studies on Consumer Responses to Nutrient Content
Claims on Fortified Foods.'' Also include the FDA docket number found
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400T, Rockville,
MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Experimental Studies on Consumer Responses to Nutrient Content Claims
on Fortified Foods--OMB Control Number 0910-New)

I. Background

    The Nutrition Labeling and Education Act gave FDA the authority to
issue regulations that require almost all packaged foods to bear
nutrition labeling. The law also allows manufacturers to provide other
nutrition information on labels in the form of various types of
statements, including claims, as long as such statements comply with
the regulatory limits that govern the use of each type of statement.
There are three types of claims that the food industry can voluntarily
use on food labels: (1) Health claims, (2) nutrient content claims, and
(3) structure/function claims. All claims must be truthful and not
misleading (Ref. 1).
    FDA's policy on fortification (21 CFR 104.20) establishes a set of
principles that serve as a model for the rational addition of nutrients
to foods. FDA has an interest in the American public achieving and
maintaining diets with optimal levels of nutritional quality, wherein
healthy diets are composed of foods from a variety of nutrient sources.
FDA does not encourage the addition of nutrients to certain food
products (including sugars or snack foods such as [cookies] candies,
and carbonated beverages). FDA is interested in studying whether
fortification of these foods could cause consumers to believe that
substituting fortified snack foods for more nutritious foods would
ensure a nutritionally sound diet.
    Research suggests consumer product perceptions and purchase
decisions can be influenced by labeling statements and different
labeling statements may have different influences (Refs. 2 through 5).
FDA, as part of its effort to promote public health, proposes to
conduct a controlled, randomized experiment to explore consumer
responses to expressed and implied nutrient content claims on the
labels of snack foods such as cookies, carbonated beverages, and candy.
The study will use a 15-minute Web-based questionnaire to collect
information from 7,500 English-speaking adult members of an online
consumer panel maintained by a contractor. Researchers will endeavor to
collect samples that reflect the U.S. Census on gender, education, age,
and ethnicity/race for both modes of administration.
    Potential conditions for the study include the following: (1) A
mock snack product with a claim similar to ``[a]s much [nutrient] as a
serving of [food product];'' (2) a mock candy with the claim ``[g]ood
source of [nutrient];'' and (3) a mock carbonated beverage with the
claim, ``product name] plus [nutrient].'' Each participant in each
study will be randomly assigned to view a label image. Each participant
in each study will also be randomly allowed or disallowed to access the
Nutrition Facts label of the product. All label images will be mock
products resembling actual food labels found in the marketplace.
    Participants will view label images and answer questions about
their perceptions and reactions to the label. Product perceptions
(e.g., healthiness, potential health benefits, levels of nutrients),
label perceptions (e.g., helpfulness and credibility), and purchase/
choice questions will constitute the measures of response in the
experiment. To help understand the data, the study will also collect
information about participants' background, such as purchase and
consumption of similar products; nutrition knowledge; dietary
interests; motivation regarding label use; health status and
demographic characteristics.
    The study is a part of the Agency's continuing effort to enable
consumers to make informed dietary choices and construct healthful
diets. Results of the study will be used primarily to inform the
Agency's understanding of how claims on the packages of fortified food
may affect how consumers perceive a product or a label, which may in
turn affect their dietary choices. The results of the study will not be
used to develop population estimates.
    In accordance with 5 CFR 1320.8(d), in the Federal Register of
August 15, 2012 (77 FR 48988), FDA published a 60-day notice requesting
public comment on the proposed information collection. FDA received six
letters in response to the notice, each containing one or more
comments. The comments, and the agency's responses, are discussed in
the following paragraphs. One of the comments received was not
responsive to the comment request on the four specified aspects of the
collection of information. This non-responsive comment will not be
addressed in this document. We respond to the remaining comments in
this document. For ease of reading, we preface each comment with a
numbered ``Comment'' and each response by a corresponding numbered
``Response.'' We have numbered each comment to help distinguish between
different topics. The number assigned to each comment is for
organizational purposes only and does not signify the comment's value,
or importance, or the order in which it was received.
    (Comment 1) Four comments expressed support of the utility of the
study for FDA's mission, stating that use of the study results will
help FDA: (1) Fulfill its role as a steward of the public health; (2)
continue to help consumers use the food label to make informed
consumption decisions; and (3) help FDA to continue the policy against
fortifying sugars or snack foods such as cookies, candies, and
carbonated beverages.

    (Response 1) FDA agrees with the comments.
    (Comment 2) Reacting to FDA's declaration in the 60-day notice (77
FR 48988), that it intends to use ``a mock snack product'' to study
nutrient content claims on fortified foods, one comment requested that
FDA limit testing of such claims to sugars, cookies, candy, and
carbonated beverages.
    (Response 2) FDA agrees with the comment. FDA will limit testing of
nutrient content claims on fortified snack foods to mock cookies,
candy, and carbonated beverages.
    (Comment 3) One comment requested that FDA use images of actual
commercially available labels for fortified snack products in the study
instead of the proposed mock snack food labels, claiming that use of
actual labels will increase the external validity of the studies.
    (Response 3) FDA disagrees with the comment. Actual labels will
increase the external validity of the findings but actual labels also
are highly likely to introduce brand effects, a bias that may be
difficult to separate from effects of the claims themselves, which is
the focus of the studies.
    Recent study design decisions have indicated that the Agency needs
a larger sample size for Study 1 than originally expected; therefore,
the Agency will not conduct Study 2 (a shopping simulation study) which
was described in the 60-day notice.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener..              75               1              75  0.083...........               6
                                                                                (5 minutes).....
Cognitive interview...........               9               1               9  1 hour..........               9
                                                                                (60 minutes)....
Pretest invitation............           1,600               1           1,600  0.033...........              53
                                                                                (2 minutes).....
Pretest.......................             400               1             400  0.25............             100
                                                                                (15 minutes)....
Survey invitation.............          32,000               1          32,000  0.033...........           1,056
                                                                                (2 minutes).....
Survey........................           7,500               1           7,500  0.25............           1,875
                                                                                (15 minutes)....
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           3,099
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

    1. U.S. Food and Drug Administration. Claims That Can Be Made
for Conventional Foods and Dietary Supplements. September 2003.
Available at http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm111447.htm.
    2. Drichoutis, A.C., P. Lazaridis, and R.M. Nayga, ``Consumers'
Use of Nutritional Labels: A Review of Research Studies and
Issues,'' Academy of Marketing Science Review, 2006(9), 2006.
Available at http://www.amsreview.org/articles/drichoutis09-2006.pdf.
    3. L[auml]hteenm[auml]ki, L., P. Lampila, and K. Grunert, et
al., ``Impact of Health-Related Claims on the Perception of Other
Product Attributes,'' Food Policy, 23: 230-239, 2010.
    4. Labiner-Wolfe, J., C.-T. J. Lin, and L. Verrill, ``Effect of
Low Carbohydrate Claims on Consumer Perceptions about Food Products'
Healthfulness and Helpfulness for Weight Management,'' Journal of
Nutrition Education and Behavior, 42(5): 315-320, 2010.
    5. Roe, B., A.S. Levy, and B.M. Derby, ``The Impact of Health
Claims on Consumer Search and Product Evaluation Outcomes: Evidence
from FDA Experimental Data,'' Journal of Public Policy and
Marketing, 18(1): 89-105, 1999.

    Dated: August 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20469 Filed 8-21-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 91 (Tuesday, May 12, 2015)]
[Notices]
[Page 27166]
[FR Doc No: 2015-11412]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2614-038]

City of Hamilton, Ohio, American Municipal Power, Inc.; Notice of
Application for Partial Transfer of License and Soliciting Comments,
Motions To Intervene, and Protests

    On April 22, 2015, the City of Hamilton, Ohio (City or transferor)
and American Municipal Power, Inc. (AMP or transferee) filed an
application to partially transfer the license for the Greenup Project
No. 2614, located on the Ohio River in Scioto County, Ohio. The
application requests to partially transfer the license for the Greenup
Project to add AMP as a co-licensee.
    The transferor and transferee seek Commission approval to a partial
transfer of the license for the Greenup Project from the City, as sole
licensee, to the City and AMP, as co-licensees.
    Applicant Contacts: For Transferor: Mr. Joshua Smith, City Manager,
City of Hamilton, 345 High Street, 7th Floor, Hamilton, OH 45011-6071,
Email<EMAIL_ADDRESS>Mr. Alan I. Robbins, Esq., Jennings
Strouss & Salmon, PLC, 1350 I Street NW., Suite 810, Washington, DC
20005, Email<EMAIL_ADDRESS>For Transferee: Mr. Marc S. Gerken,
P.E., President and CEO, American Municipal Power, Inc., 1111 Schrock
Road, Suite 100, Columbus, OH 43229, Email<EMAIL_ADDRESS>
Mr. Phil E. Meier, Vice President, Hydro Development and Operations,
American Municipal Power, Inc., 1111 Schrock Road, Suite 100, Columbus,
OH 43229, Email<EMAIL_ADDRESS>and Mr. John W. Bentine, Esq.,
Sr. Vice President and General Counsel, Email:
<EMAIL_ADDRESS>American Municipal Power, Inc., 1111 Schrock
Road, Suite 100, Columbus, OH 43229
    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, and protests:
30 days from the date that the Commission issues this notice. The
Commission strongly encourages electronic filing. Please file motions
to intervene, comments, and protests using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. The first page of any filing should
include docket number P-2614-038.

    Dated: April 28, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-11412 Filed 5-11-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 73 (Thursday, April 16, 2015)]
[Notices]
[Pages 20544-20548]
[FR Doc No: 2015-08696]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74702; File No. SR-BATS-2015-31]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Amend
Rule 11.23, ``Auctions''

April 10, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 1, 2015, BATS Exchange, Inc. (the ``Exchange'' or ``BATS'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Exchange has
designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6) thereunder,\4\ which renders it effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend Rule 11.23, entitled
``Auctions.''
    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.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 proposes to make several changes to Rule 11.23 in
order to improve the Exchange auction process. Specifically, the
Exchange is proposing to make several minor changes to Rule 11.23,
which include: (i) To eliminate from each of the Opening Auction,
Closing Auction, IPO and Halt Auction, and Volatility Closing Auction
the language stating that an auction will occur at the price of the
Volume Based Tie Breaker (or ``VBTB''),\5\ Final Last Sale Eligible
Trade,\6\ or issuing price, as applicable, where no limit orders from
one or both sides would participate in the auction; (ii) to amend the
definition of Volume Based Tie Breaker; (iii) to amend the definition
of Reference Price Range; \7\ (iv) to amend the definition of Late-
Limit-On-Close \8\ (``LLOC'') and Late-Limit-On-Open \9\ (``LLOO'');
and (v) to make a non-substantive change to delete the definitions of
ZBB,\10\ ZBO,\11\ and ZBBO.\12\
---------------------------------------------------------------------------

    \5\ As defined in BATS Rule 11.23(a)(23).
    \6\ As defined in BATS Rule 11.23(a)(9).
    \7\ As defined in BATS Rule 11.23(a)(20).
    \8\ As defined in BATS Rule 11.23(a)(11).
    \9\ As defined in BATS Rule 11.23(a)(12).
    \10\ As defined in BATS Rule 11.23(a)(24).
    \11\ Id.
    \12\ Id.
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Limit Order Participation
    Currently, each of Rules 11.23(b)(2)(B), (c)(2)(B), (d)(2)(C), and
(e)(2)(B) contain language that provides an alternate price at which an
auction will occur where no limit orders from one or both sides (the
buy side, the sell side, or both the buy and sell side) would otherwise
participate in an auction (an ``Alternate Price''). For Opening and
Closing Auctions the Alternate Price is the Volume Based Tie Breaker;
for Halt and Volatility Closing Auctions the Alternate Price is the
Final Last Sale Eligible Trade; and for IPO Auctions the Alternate
Price is the issuing price. While the Exchange added the Alternate
Price requirement in order to ensure that, for auctions with minimal
liquidity, either limit orders were participating in the auction and
would aid in price discovery or that the auction would occur at a pre-
determined price, this protection has,

based on analysis by the Exchange and feedback from issuers and market
participants, resulted in orders not receiving executions in auctions
that would have otherwise occurred at prices that would have been
acceptable to both parties to the execution that did not occur. To
illustrate this point, the Exchange presents the following example: At
the time that an Opening Auction is occurring, there is no ZBBO and the
NBBO is $9.90 x $10.10. In this situation, the Volume Based Tie Breaker
would be the midpoint of the NBBO,\13\ which would be $10.00.\14\ Based
on a Volume Based Tie Breaker of $10.00, the Collar Price Range \15\
would be $9.00 to $11.00 (the range from 0.90*VBTB to 1.10*VBTB). In
this example, there are only two orders on the Auction Book \16\ for
the security: A Limit-On-Open\17\ buy order for 100 shares with a limit
price of $9.99 and a Market-On-Open \18\ sell order for 100 shares.
Without the requirement that the auction occur at the Alternate Price
where a limit order from both sides does not participate in the
auction, there would have been an execution of 100 shares in the
Opening Auction at $9.99.\19\ However, because there would be no limit
orders on the sell side that would participate in the Opening Auction,
under current functionality the Opening Auction would be forced to
occur at the Volume Based Tie Breaker, which is $10.00. However,
because the limit price of the Limit-On-Open buy order is $9.99, no
execution will occur, both orders will be cancelled, and trading will
transition into Regular Trading Hours.\20\ This example is identical to
how a Closing Auction would occur and is nearly identical to examples
of how the Alternate Price could affect other auctions.
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    \13\ See supra note 4 [sic]. By definition, where there is no
ZBBO, the Volume Based Tie Breaker will be the midpoint of the NBBO.
    \14\ The Exchange notes that it is proposing to amend the
definition of Volume Based Tie Breaker, as further described below,
but none of the proposed changes would affect the outcome of this
example.
    \15\ See BATS Rule 11.23(a)(6). By definition, for Opening
Auctions where the Volume Based Tie Breaker is $25.00 or less, the
Collar Price Range shall be the range from 10% below the VBTB to 10%
above the VBTB, which would be $9.00 to $11.00 in the example above.
    \16\ As defined in BATS Rule 11.23(a)(1).
    \17\ As defined in BATS Rule 11.23(a)(14).
    \18\ As defined in BATS Rule 11.23(a)(16).
    \19\ Absent the existing Alternate Price language, the price of
the Opening Auction in the above described example would be
determined by the first two sentences of BATS Rule 11.23(b)(2)(B),
which provide the following: ``The Opening Auction price will be
established by determining the price level within the Collar Price
Range that maximizes the number of shares executed between the
Continuous Book and Auction Book in the Opening Auction. In the
event of a volume based tie at multiple price levels, the Opening
Auction price will be the price closest to the Volume Based Tie
Breaker.'' In the example described above, there would be an equal
number of shares that could be executed at every price level from
$9.00 to $9.99, however the price of the auction would be $9.99
because that is the price level at which there is a volume based tie
that is closest to the Volume Based Tie Breaker. Such language is
currently the basis for determining the price of every auction that
occurs on the exchange except in those instances that there is no
limit interest participating in one or both sides or no auction
occurs (noting that the Opening and Closing Auctions both use VBTB,
while Halt and Volatility Closing Auctions use the Final Last Sale
Eligible Trade and IPO Auctions use the issue price for resolving
ties at multiple price levels). Further, in the event that there is
no limit interest that would participate on either side of an
auction (i.e. only market interest on both sides), such language
would create the same auction price (the Alternate Price) as the
language that the Exchange is proposing to delete because there
would be a tie at every price level within the Collar Price Range,
meaning that the price would default to the Alternate Price.
    \20\ As defined in BATS Rule 1.5(w).
---------------------------------------------------------------------------

    The Exchange is proposing to eliminate the language that provides
an Alternate Price at which an auction will occur where no limit orders
from one or both sides (the buy side, the sell side, or both the buy
and sell side) would otherwise participate in an auction. As proposed,
the example constructed above would result in an execution of 100
shares at $9.99, which would represent a full execution for both
orders. It's worth noting that the Limit-On-Open order could have been
priced as low as $9.00 (the low end of the Collar Price Range) and the
auction would have occurred at the price of the Limit-On-Open order.
The Exchange originally added the language that it is proposing to
delete as part of a proposal to eliminate the possibility that a
single, non-marketable limit order could affect the price at which an
auction occurred.\21,\ \22\ The resulting rule text, however, took the
solution beyond merely preventing a single limit order from determining
the price at which an auction would occur and instead provided that
limit interest on both sides must participate in an auction or the
auction would be forced to occur at an Alternate Price. The Exchange
now believes, however, that the current rule text adopted the wrong
approach to solving the problem described above, which has resulted in
the unnecessary prevention of certain otherwise marketable limit
orders, such as the $9.99 Limit On Open order from the example above,
from executing in auctions on the Exchange. Further, the Exchange also
believes that the current rule text creates an overly restrictive
collar on market orders entered to participate in auctions under the
conditions described above: where no limit orders participate on one or
both sides of the market, a market order can never be priced more
aggressively than the Alternate Price. The Exchange believes that the
rule text results in the treatment of market orders that differs from
the general understanding of how market orders are priced and, as
mentioned above, the Exchange has received feedback from market
participants and issuers indicating an agreement with this belief. The
proposed amendments would result in market orders being treated in a
manner similar to aggressively priced limit orders, which is more in
line with the generally understood definition of a market order. This
feedback from stakeholders along with an internal review of auctions
occurring on the Exchange that arrived at similar conclusions have led
the Exchange to believe that allowing market orders to execute at any
point within the Collar Price Range regardless of whether any limit
interest would participate in the auction will allow executions to
occur in the auctions at prices that are more reflective of market
conditions at the time of the auction by allowing marketable limit
orders priced within the Collar Price Range to interact with contra-
side market orders. The Exchange notes that both market and limit
orders will still have several protections in place as auctions can
only occur within the Collar Price Range and the protections afforded
under the Exchange's clearly erroneous rules in BATS Rule 11.17 also
apply to executions that occur in an auction.
---------------------------------------------------------------------------

    \21\ See Securities Exchange Act Release No. 68788 (January 31,
2013), 78 FR 8640 (February 6, 2013) (SR-BATS-2012-046) (the
``Filing''). On pages 7 and 8 of the Filing, the Exchange provides:
``Where no limit orders from either or both sides would participate
in the auction, the Exchange is proposing that the auction will
occur at the price of the Default Price. By providing that the
auction price will be the Default Price where no limit orders from
one or both sides would participate in an Exchange Auction, this
proposed language [sic] would aid in price discovery and help to
prevent erroneous executions by ensuring that a single limit order
on one side of an auction that might not even participate in the
Exchange Auction cannot on its own determine the auction price.''
    \22\ Prior to the changes implemented upon approval of the
Filing, the language for Opening and Closing Auctions that preceded
the current Alternate Price language read as follows: ``In the event
that at the time of the [auction] there are no limit orders on both
the Continuous Book and the Auction Book, the [auction] will occur
at the price of the Final Last Sale Eligible Trade.'' For IPO and
Halt Auctions, the language read as follows: ``In the event that
there are no limit orders among the Eligible Auction Orders for a
[auction], the [auction] will occur at the [Alternate Price].
---------------------------------------------------------------------------

Volume Based Tie Breaker
    Currently, the term ``Volume Based Tie Breaker'' shall mean the
midpoint of the ZBBO for a particular security. In the event that there
is either no ZBB or

ZBO for the security, the NBBO will be used if there is at least one
limit order on either the Continuous Book \23\ or the Auction Book. In
the event that there is also no NBB or NBO for the security or no limit
orders on the Continuous Book and the Auction Book, the price of the
Final Last Sale Eligible Trade will be used.
---------------------------------------------------------------------------

    \23\ As defined in BATS Rule 11.23(a)(7).
---------------------------------------------------------------------------

    The Exchange is proposing to eliminate the concept of ZBBO from the
definition of Volume Based Tie Breaker. Specifically, the Exchange is
proposing to amend the definition such that the Volume Based Tie
Breaker will either be the midpoint of the NBBO or the price of the
Final Last Sale Eligible Trade.
    The Exchange is also proposing to validate a NBBO prior to using
the midpoint of that NBBO as the Volume Based Tie Breaker.
Specifically, the Exchange is proposing to validate that a NBBO is
sufficiently tight to use the NBBO as a basis for establishing the
Volume Based Tie Breaker as follows: A NBBO is a valid NBBO where (i)
there is both a NBB and NBO for the security; (ii) the NBBO is not
crossed; and (iii) the midpoint of the NBBO is less than the Maximum
Percentage away from both the NBB and the NBO. The Maximum Percentage
will be determined by the Exchange and will be published in a circular
distributed to Members with reasonable advance notice prior to initial
implementation and any change thereto. The Exchange will retain
discretion to set and adjust the Maximum Percentage as it deems
appropriate, but notes that the Maximum Percentage will never exceed
the clearly erroneous thresholds from BATS Rule 11.17 based on the
price of the security and that it will communicate any changes to the
Maximum Percentage via circular to Members. The Exchange has monitored
its auction process historically and believes that the initial levels
that it sets for the Maximum Percentage will be appropriate. The
Exchange does not anticipate adjusting the Maximum Percentage on a
regular basis, however it will continue to monitor its auction process
going forward and believes that retaining the discretion to increase or
decrease the Maximum Percentage in order to adjust the threshold for
what it believes to be a sufficiently narrow NBBO to choose a
reasonable Volume Based Tie Breaker will allow it the administrative
flexibility to make adjustments that will ensure sufficient protections
for all participants in auctions on the Exchange. The Exchange notes
that it will not apply separate standards for the Maximum Percentage on
a security by security basis. Further, this discretion applies to only
one of three factors in determining whether a NBBO is a Valid NBBO and
where the NBBO is determined not to be a Valid NBBO, the Volume Based
Tie Breaker will still be based on market conditions: the Final Last
Sale Eligible Trade will be used instead of the midpoint of the NBBO.
As part of this proposal, the Exchange would also eliminate the rule
text requiring that there be a limit order on either the Continuous
Book or the Auction Book for the midpoint of the NBBO to be used as the
Volume Based Tie Breaker.
Reference Price Range
    Currently, the term Reference Price Range means the range from the
ZBB to the ZBO for a particular security. In the event that there is
either no ZBB or ZBO for the security, the NBBO will be used if there
is at least one limit order on either the Continuous Book or the
Auction Book. In the event that there is also either no NBB or NBO for
the security or no limit orders on the Continuous Book and the Auction
Book, the price of the Final Last Sale Eligible Trade will be used.
    The Exchange is proposing to amend the definition of Reference
Price Range in order to eliminate the concept of ZBBO from the
calculation of the Reference Price Range. Specifically, the Exchange is
proposing to amend the definition such that the Reference Price Range
will either be the range from the NBB to the NBO for a particular
security or the price of the Final Last Sale Eligible Trade. As part of
this proposal, the Exchange would also eliminate the rule text
requiring that there be a limit order on either the Continuous Book or
the Auction Book for the Reference Price Range to be the range from the
NBB to the NBO.
LLOC and LLOO
    The Exchange is proposing to amend the definition of LLOC and LLOO
orders to eliminate the use of ZBBO in pricing the orders. Currently,
the Exchange first looks to the ZBBO to determine the most aggressive
price that LLOC and LLOO orders can be priced and, where there is no
ZBB or ZBO, the Exchange instead looks to the NBB or NBO, respectively.
Where there is no NBB or NBO, the Exchange allows the LLOC or LLOO bid
or offer, respectively, to be priced at its entered limit price. The
Exchange is proposing to eliminate the ZBBO component of the process
and instead to either restrict an order's price based on the NBBO or,
absent either a NBB or NBO, to allow a bid or offer, respectively, to
be priced at its entered limit price. As part of these proposed
changes, the Exchange is also proposing to add language to make clear
that a LLOC or LLOO bid will only be priced as aggressively as the NBB,
even if there is no NBO and that an offer will only be priced as
aggressively as the NBO, even if there is no NBB. Currently, the rule
states that if there is no NBBO, the LLOC or LLOO will assume its
entered limit price. The Exchange is proposing to make clear that where
there is no NBB, a LLOC or LLOO bid will assume its entered limit price
and where there is no NBO, a LLOC or LLOO offer will assume its entered
limit price. A LLOC or LLOO bid will not assume its entered price only
because there is no NBO and a LLOC or LLOO offer will not assume its
entered price only because there is no NBB. This is consistent with
existing behavior and is merely intended to provide additional clarity
about how LLOC and LLOO orders are priced.
ZBBO
    In conjunction with the changes proposed above, the Exchange is
also proposing to delete Rule 11.23(a)(24) which defines the terms ZBB,
ZBO, and ZBBO because the Exchange is also proposing to delete each
reference to ZBB, ZBO, and ZBBO in its rules and the definition is no
longer necessary.
2. Statutory Basis
    The Exchange believes that 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.\24\ Specifically, the proposed change is consistent with
Section 6(b)(5) of the Act,\25\ 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. Generally, the
Exchange believes that the proposed changes will improve the price
discovery process for securities listed on the Exchange along with
those additional benefits enumerated below.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78f(b).
    \25\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

Limit Order Participation
    The Exchange believes that the proposed amendments to each of the
Opening Auction, Closing Auction, IPO and Halt Auction, and Volatility
Closing Auction 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 in that it would eliminate a protection from the
auction process that, as described above, was more restrictive than
anticipated. As stated above, the current implementation that provides
that an auction must occur at an Alternate Price where there would not
be limit order participation on both sides of an auction was intended
to eliminate the possibility that a single, non-marketable limit order
could affect the price at which an auction occurred.\26\ However, as
illustrated by the examples above, the current rule text went beyond
merely preventing a single limit order from determining the price at
which an auction would occur and instead provided that limit interest
on both sides must participate in an auction or the auction would be
forced to occur at an Alternative Price. The Exchange now believes,
however, that the current rule text adopted the wrong approach to
solving the problem described above, which has resulted in the
unnecessary prevention of certain otherwise marketable limit orders,
such as the $9.99 Limit On Open order from the example above, from
executing in auctions on the Exchange. Further, the Exchange also
believes that the current rule text creates an overly restrictive
collar on market orders entered to participate in auctions under the
conditions described above: where no limit orders participate on one or
both sides of the market, a market order can never be priced more
aggressively than the Alternate Price. The Exchange believes that the
rule text results in the treatment of market orders that differs from
the general understanding of how market orders are priced and, as
mentioned above, the Exchange has received feedback from market
participants and issuers indicating an agreement with this belief. As
such, the Exchange believes that the proposal 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 by allowing
executions to occur in auctions at prices that are more reflective of
market conditions at the time of the auction by allowing marketable
limit orders priced within the Collar Price Range to interact with
contra-side market orders. The Exchange emphasizes that it is not
proposing to allow market orders to participate in its auctions without
any price protections. Rather, the Exchange is proposing to treat
market orders in its auctions in a manner broadly consistent with the
rules of other exchanges.\27\ The Exchange believes that the Collar
Price Range, which is based on the clearly erroneous standards in BATS
Rule 11.17, and the clearly erroneous process in BATS Rule 11.17, which
applies to executions in the auctions and could be used to cancel any
executions to which it applies, provide sufficient protections against
executions in the auctions occurring at extreme prices. As such, the
Exchange believes that a better characterization is that the Exchange
is proposing to treat market orders in a manner more similar to
aggressively priced limit orders, which is more in line with the
generally understood meaning of a market order. With this in mind, the
Exchange believes that the proposed amendments to eliminate the
Alternate Price where there would not be limit order participation on
both sides of an auction 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.
---------------------------------------------------------------------------

    \26\ See supra notes 21 and 22.
    \27\ See NYSE Arca, Inc. (``Arca'') Rule 7.35 and NASDAQ Stock
Market LLC (``Nasdaq'') Rules 4752, 4753, and 4754. While each of
the exchanges have very diverse rules governing auctions/crosses on
their respective venues, neither Arca nor Nasdaq have a comparable
requirement that unless limit interest from both sides would
participate in the auction, the auction will occur at a default
price. As such, the Exchange believes that elimination of the
requirement is broadly consistent with the rules of other exchanges.
---------------------------------------------------------------------------

Volume Based Tie Breaker
    The Exchange believes that the proposed amendments to the Volume
Based Tie Breaker 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 in that it would ensure that the Volume Based
Tie Breaker would be calculated using a full picture of the market in a
particular security by looking to the NBBO instead of the ZBBO,
regardless of whether there are any limit orders on the Continuous Book
or Auction Book. Because the NBBO by definition accounts for the ZBBO,
the NBBO will always be equal to or tighter than the ZBBO, which the
Exchange believes creates a Volume Based Tie Breaker that better
reflects current market conditions. Further to this point, the Exchange
believes that creating a process to validate the NBBO or, where the
NBBO is not valid, to use the Final Last Sale Eligible Trade will
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 in that it will ensure that the NBBO is sufficiently tight to
guarantee that the midpoint of the NBBO would be a meaningful and
accurate Volume Based Tie Breaker.
Reference Price Range
    The Exchange believes that the proposed amendments to the
definition of Reference Price Range 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 in that it would ensure that
the Reference Price Range would be calculated using a full picture of
the market in a particular security by looking to the NBBO instead of
the ZBBO, regardless of whether there are any limit orders on the
Continuous Book or Auction Book. Because the NBBO by definition
accounts for the ZBBO, the NBBO will always be equal to or tighter than
the ZBBO, which the Exchange believes creates a Reference Price Range
that better reflects current market conditions.
LLOC and LLOO
    The Exchange believes that the proposed amendments to the
definition of LLOC and LLOO 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 in that it would ensure that the LLOC
and LLOO orders would be priced using a full picture of the market in a
particular security by looking to the NBBO instead of the ZBBO. Because
the NBBO by definition accounts for the ZBBO, the NBBO will always be
equal to or tighter than the ZBBO, which the Exchange believes provides
a better basis by which to price a LLOC or LLOO order because it better
reflects current market conditions. The Exchange also believes that the
clarifying changes to the definitions of LLOC and LLOO explained above
will contribute to the protection of investors and the public interest
by making the functionality of LLOC and LLOO orders as clear as
possible.
ZBBO
    The Exchange believes that the non-substantive proposal to delete
the

definitions of ZBB, ZBO, and ZBBO, as discussed above, will contribute
to the protection of investors and the public interest by eliminating
the definition of a term that is no longer used in the Exchange's Rules
which will make the Exchange's Rules easier to understand and help to
avoid confusion.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the act. To the contrary, allowing the
Exchange to make the above proposed modifications to Rule 11.23 in
order to allow an auction to occur at a price that is not the Alternate
Price where there isn't limit interest on both sides (Limit Order
Participation), to eliminate the use of ZBB, ZBO, and ZBBO from the
auction process (Volume Based Tie Breaker, Reference Price Range, LLOC
and LLOO, and ZBBO), to validate the NBBO before using it to establish
the Volume Based Tie Breaker (Volume Based Tie Breaker), and to
eliminate the requirement that there be at least one limit order on
either the Continuous Book or the Auction Book in order to use the NBBO
for the Volume Based Tie Breaker or the Reference Price (Volume Based
Tie Breaker and Reference Price) will, in the aggregate, allow the
Exchange to better compete with other exchanges as a listing venue by
improving the Exchange's auction process by allowing more executions to
occur at more reasonable prices that are based on market-wide pricing.
As mentioned above, the Exchange has received feedback from market
participants and issuers alike regarding these issues and the proposed
amendments will both address this feedback and improve the Exchange's
auction process, allowing it to better compete as both a listing and
execution venue.

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 the proposed rule change. The Exchange has, however, as
described above, received unsolicited comments from both Members and
issuers that helped lead to the changes proposed herein.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \28\ and Rule 19b-4(f)(6) thereunder.\29\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \30\ and Rule 19b-
4(f)(6) thereunder.\31\
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \29\ 17 CFR 240.19b-4(f)(6).
    \30\ 15 U.S.C. 78s(b)(3)(A).
    \31\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or 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 email to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2015-31 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BATS-2015-31. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices 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-BATS-2015-31,
and should be submitted on or before May 7, 2015.
---------------------------------------------------------------------------

    \32\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\32\
Brent J. Fields,
Secretary.
[FR Doc. 2015-08696 Filed 4-15-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Rules and Regulations]
[Pages 10590-10591]
[FR Doc No: 2015-04152]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-1070]
RIN 1625-AA09

Drawbridge Operation Regulation; Passaic River, Rutherford, NJ

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is removing the existing drawbridge operation
regulation for the drawbridge across the Passaic River, mile 11.8, at
Rutherford, New Jersey. The drawbridge was converted to a fixed bridge
in October 2010, and the operating regulation is no longer applicable
or necessary.

DATES: This rule is effective February 27, 2015.

ADDRESSES: The docket for this final rule, [USCG-2014-1070] is
available at http://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH.'' Click on Open Docket Folder on the
line associated with this final rule. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Joe Arca, Project Officer, First Coast Guard District
Bridge Program, telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If
you have questions on viewing the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

A. Regulatory History and Information

    The Coast Guard is issuing this final 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), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Route 3 Bridge, that once
required draw operations in 33 CFR 117.739(n), was converted to a fixed
bridge in October 2010. Therefore, the regulation is no longer
applicable and shall be removed from publication. It is unnecessary to
publish an NPRM because this regulatory action does not purport to
place any restrictions on mariners but rather removes a restriction
that has no further use or value.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective in less than 30 days after
publication in the Federal Register. The bridge has been a fixed bridge
for 4 years and this rule merely requires an administrative change to
the Federal Register, in order to omit a regulatory requirement that is
no longer applicable or necessary.

B. Basis and Purpose

    The Route 3 Bridge across the Passaic River, mile 11.8, was
converted to a fixed bridge in 2010. It has come to the attention of
the Coast Guard that the governing regulation for this drawbridge was
never removed subsequent to the conversion to a fixed bridge. The
conversion of this drawbridge necessitates the removal of the
drawbridge operation regulation, 33 CFR 117.739(n), pertaining to the
former drawbridge.
    The purpose of this rule is to remove paragraph 33 CFR 117.739(n),
that refers to the Route 3 Bridge at mile 11.8, from the Code of
Federal Regulations since it governs a bridge that is no longer able to
be opened.

C. Discussion of Rule

    The Coast Guard is changing the regulation in 33 CFR 117.739 by
removing restrictions and the regulatory burden related to the draw
operations for this bridge that is no longer a drawbridge. The change
removes paragraph 117.739(n) of the regulation which governs the Route
3 Bridge and redesignates (o) through (t) as (n) through (s). This
Final Rule seeks to update the Code of Federal Regulations by removing
language that governs the operation of the Route 3 Bridge, which in
fact no longer is a drawbridge. This change does not affect waterway or
land traffic. This change does not affect nor does it alter the
operating schedules in 33 CFR 117.739 that govern the remaining active
drawbridges on the Passaic River except to redesignate these bridges.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders.
    The Coast Guard does not consider this rule to be ``significant''
under that Order because it is an administrative change and does not
affect the way vessels operate on the waterway.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 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 have no effect on small entities since this
drawbridge has been converted to a fixed bridge and the regulation
governing draw operations for this bridge is no longer applicable.
There is no new restriction or regulation being imposed by this rule;
therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this
final rule will not have a significant economic impact on a substantial
number of small entities.

3. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

4. Federalism

    A rule has implications for federalism under Executive Order 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 does not have implications for federalism.

5. 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.

6. 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.

7. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

8. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

9. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

10. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
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.

11. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

12. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

13. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
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 involves the removal of a drawbridge operation
regulation that is no longer necessary. This rule is categorically
excluded, under figure 2-1, paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117 Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

Sec.  117.739  [Amended]

0
2. In Sec.  117.739, remove paragraph (n) and redesignate paragraphs
(o) through (t) as paragraphs (n) through (s).

    Dated: January 29, 2015.
L.L. Fagan,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2015-04152 Filed 2-26-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47149-47151]
[FR Doc No: 2023-15458]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0343]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice for Blood and Blood Components and Reducing the
Risk of Transfusion-Transmitted Infections

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by August 21, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0116. Also include the FDA docket
number found in brackets in the heading of this document.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Current Good Manufacturing Practice for Blood and Blood Components and
Reducing the Risk of Transfusion-Transmitted Infections

OMB Control Number 0910-0116--Revision

    The FDA's Center for Biologics Evaluation and Research (CBER) is
responsible for regulatory oversight of the U.S. blood supply. FDA
issues and enforces requirements for blood collection and for the
manufacturing of blood products, including both blood components
intended for transfusion or for further manufacturing use. To implement
applicable statutory provisions, regulations are codified at 21 CFR
part 606--Current Good Manufacturing Practice for Blood and Blood
Components; 21 CFR part 610--General Biological Products Standards; 21
CFR part 630--Requirements for Blood and Blood Components Intended for
Transfusion or for Further Manufacturing Use; and 21 CFR part 640--
Additional Standards for Human Blood and Blood Products. The
regulations establish quality standard requirements applicable to blood
and blood products including information collection provisions.
    CBER works closely with other parts of the Department of Health and
Human Services to identify and respond to potential threats to blood
safety and to monitor the availability of the blood supply. FDA has
progressively strengthened the overlapping safeguards that help to
ensure donor health and the safety of the blood supply for recipients
of blood and blood products. For example:
     Blood donors answer medical history questions to identify
risk factors that could indicate possible infection with a relevant-
transfusion transmitted infection.
     FDA requires blood establishments to maintain a record of
deferred donors to prevent collections from ineligible donors.
     Blood donations are tested for several relevant
transfusion-transmitted infections, including HIV, hepatitis B virus,
and hepatitis C virus.
    FDA also inspects blood establishments and monitors reports of
errors, accidents, and adverse events associated with blood donation or
transfusion.
    Description of Respondents: Respondents to the collection of
information are licensed and registered-only establishments that
collect blood and blood components intended for transfusion or further
manufacturing use.
    For operational efficiency, we are revising the information
collection to account for burden that may be attributable to
recommendations found in associated FDA guidance documents, as listed
below, and currently approved in OMB control number 0910-0681. FDA
regulations in Sec.  630.3(h) (21 CFR 630.3(h)) set forth a list of
relevant transfusion-transmitted infections (RTTIs) (Sec.  630.3(h)(1))
and the conditions under which a TTI would meet the definition of an
RTTI (Sec.  630.3(h)(2)). We developed Agency guidance documents,
consistent with our good guidance practice regulations in 21 CFR
10.115, that provide for comment at any time. These guidance documents
include recommendations specific to certain RTTI or TTI regarding the
collection of blood and blood components and discuss corresponding
recordkeeping and/or notification activities. The guidance documents
are available for download from our website at https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances.

A. Guidances Recommending Notification Based on Reactive Test Results

    The following guidance documents provide recommendations for
consignee and physician notification relating to donations that test
reactive for an RTTI:
     Guidance for Industry: Use of Nucleic Acid Tests to Reduce
the Risk of Transmission of West Nile Virus from Donors of Whole Blood
and Blood Components Intended for Transfusion (November 2009);
     Use of Serological Tests to Reduce the Risk of
Transmission of Trypanosoma cruzi Infection in Blood and Blood
Components; Guidance for Industry (December 2017);
     Recommendations for Reducing the Risk of Transfusion-
Transmitted Babesiosis; Guidance for Industry (May 2019); and
     Use of Serological Tests to Reduce the Risk of
Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II
(HTLV-I/II); Guidance for Industry (February 2020).

B. Guidances Recommending Notification Based on Post Donation
Information Regarding a Risk Factor or History of an RTTI or TTI

    The following guidance documents provide recommendations for
consignee and, in some instances, physician notification under
circumstances where a blood establishment may receive information
following collection that reveals the donor had a history of or risk
factor for an RTTI or TTI at the time of collection and should have
been deferred for the risk factor:
     Recommendations for Assessment of Blood Donor Eligibility,
Donor Deferral and Blood Product Management in Response to Ebola Virus;
Guidance for Industry (January 2017);
     Recommendations to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Components; Guidance for Industry (May
2022); and
     Recommendations to Reduce the Risk of Transfusion-
Transmitted Malaria; Guidance for Industry (December 2022).
    In the Federal Register of February 21, 2023 (88 FR 10515), we
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four information collection topics solicited. On
our own initiative we have since revised the information collection to
reflect recent finalization of the guidance document entitled
``Recommendations for Evaluating Donor Eligibility Using Individual
Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus
Transmission by Blood and Blood Products,'' announced in the Federal
Register of May 12, 2023 (88 FR 30765). The recommendations included in
the guidance document will potentially expand the number of people
eligible to donate blood, while also maintaining the appropriate
safeguards to protect the safety of the blood supply.
    We believe the notifications discussed in the respective guidance
documents are rare and that these notification practices would be part
of the usual and customary business practice for blood establishments
and consignees in addressing the RTTIs or TTIs under the regulations.
We also believe respondents would have already developed standard
operating procedures for notifying consignees and the recipient's
physician of record regarding distributed blood components potentially
at risk for an RTTI or TTI. However, to account for burden among
respondents that may be attributable to the notification activity we
allot one response and 1 hour annually. As additional guidance is
developed by FDA addressing other RTTIs under Sec.  630.3(h)(2), we
will modify the information collection accordingly.

    Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15458 Filed 7-20-23; 8:45 am]
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