[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42880-42882]
[FR Doc No: 2020-15243]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1400]

Use of Real-World Data and Real-World Evidence To Support
Effectiveness of New Animal Drugs; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #266 entitled
``Use of Real-World Data and Real-World Evidence to Support
Effectiveness of New Animal Drugs.'' The draft guidance, if finalized,
will describe FDA's current thinking with respect to assisting sponsors
in incorporating real-world data and real-world evidence (including
ongoing surveillance activities, observational studies, and registry
data) into proposed clinical investigation protocols and applications
for new animal drugs under the Federal Food, Drug, and Cosmetic Act
(FD&C Act).

DATES: Submit either electronic or written comments on the draft
guidance by October 13, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or

confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1400 for ``Use of Real-World Data and Real-World Evidence to
Support Effectiveness of New Animal Drugs.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Susan Storey, Center for Veterinary
Medicine (HFV-131), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of draft GFI #266 entitled ``Use
of Real-World Data and Real-World Evidence to Support Effectiveness of
New Animal Drugs.'' Section 305 of the Animal Drug and Animal Generic
Drug User Fee Amendments of 2018 (Pub. L. 115-234), among other things,
directed FDA to hold a public meeting for interested parties to discuss
innovative animal drug investigation designs and to issue guidance
addressing the incorporation of the use of such elements of
investigations as complex adaptive and other novel investigation
designs, data from foreign countries, real-world evidence (including
ongoing surveillance activities, observational studies, and registry
data), biomarkers, and surrogate endpoints into proposed clinical
investigation protocols and applications for new animal drugs.
    In the Federal Register of July 9, 2019 (84 FR 32749), FDA's Center
for Veterinary Medicine (CVM) published a notice of a public meeting
entitled ``Incorporating Alternative Approaches in Clinical
Investigations for New Animal Drugs'' giving interested persons until
August 17, 2019, to comment on the topics discussed at the public
meeting and the questions published in the meeting notice (84 FR 32749
at 32750 to 32751). On August 13, 2019, we published a notice
announcing the extension of the comment period to September 16, 2019
(84 FR 40071). CVM received numerous comments on the topics discussed
at the public meeting and the questions published in the meeting notice
and those comments were considered as the draft GFI #266 was developed.
    This draft guidance describes how CVM intends to evaluate real-
world data and real-world evidence in submissions to CVM to demonstrate
substantial evidence of effectiveness for new animal drug applications
or a reasonable expectation of effectiveness for applications for
conditional approval of a new animal drug. It also provides information
about how sponsors may obtain feedback from CVM on technical issues
related to the use of real-world data and real-world evidence before
the submission of an application.
    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
if finalized, will represent the current thinking of FDA regarding the
use of real-world data and real-world evidence (including ongoing
surveillance activities, observational studies, and registry data) in
submissions to CVM to support the effectiveness of new animal drugs. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3521) is not required.
    However, this draft guidance refers to previously approved FDA
collections of information found in FDA regulations for new animal drug
applications submitted under section 512(b) (21 U.S.C. 360b(b)) and 571
(21 U.S.C. 360ccc-1) of the FD&C Act. These collections of information
are subject to review by OMB under the PRA. The collections of
information in 21 CFR

part 514 have been approved under OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry or https://www.regulations.gov.

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15243 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Notices]
[Pages 83320-83322]
[FR Doc No: 2016-27892]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79312; File No. SR-BatsBZX-2016-75]

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Extend
the Pilot Period for the Supplemental Competitive Liquidity Provider
Program

November 15, 2016.
    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 November 7, 2016, Bats BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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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 filed a proposal to extend the pilot period for the
Exchange's Supplemental Competitive Liquidity Provider Program (the
``Program''), which is currently set to expire on November 4, 2016 to
expire on July 31, 2017.
    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
Background
    On August 30, 2011, the Exchange received approval of rules
applicable to the qualification, listing and delisting of securities of
issuers on the Exchange.\3\ More recently, the Exchange received
approval to operate a pilot program that is designed to incentivize
certain Market Makers \4\ registered with the Exchange as ETP CLPs, as
defined in Interpretation and Policy .03 to Rule 11.8, to enhance
liquidity on the Exchange in certain ETPs \5\ listed on the Exchange
and thereby qualify to receive part of a daily rebate as part of the
Program under Interpretation and Policy .03 to Rule 11.8.\6\
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    \3\ See Securities Exchange Act Release No. 65225 (August 30,
2011), 76 FR 55148 (September 6, 2011) (SR-BATS-2011-018).
    \4\ As defined in BZX Rules, the term ``Market Maker'' means a
Member that acts a as a market maker pursuant to Chapter XI of BZX
Rules.
    \5\ ETP is defined in Interpretation and Policy .03(b)(4) to
Rule 11.8.
    \6\ See Securities Exchange Act Release No. 72692 (July 28,
2014), 79 FR 44908 (August 1, 2014) (SR-BATS-2014-022) (``CLP
Approval Order'').
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    The Program was approved by the Commission on a pilot basis running
one-year from the date of implementation.\7\ The Commission approved
the Program on July 28, 2014.\8\ The Exchange implemented the Program
on July 28, 2014 and the pilot period for the Program was originally
scheduled to end on July 28, 2015 until it was extended to end on
October 28, 2015,\9\ later extended to January 28, 2016,\10\ again
extended to April 28, 2016,\11\ then again to July 28, 2016,\12\ again
to October 28, 2016,\13\ and most recently to November 4, 2016.\14\
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    \7\ See id at 44909.
    \8\ Id.
    \9\ See Securities Exchange Act Release No. 75518 (July 24,
2015), 80 FR 45566 (July 30, 2015 (SR-BATS-2015-55).
    \10\ See Securities Exchange Act Release No. 76293 (October 28,
2015), 80 FR 67808 (November 3, 2015) (SR-BATS-2015-96).
    \11\ See Securities Exchange Act Release No. 77033 (February 2,
2016), 81 FR 6558 (February 8, 2016) (SR-BATS-2016-12).
    \12\ See Securities Exchange Act Release No. 77721 (April 27,
2016), 81 FR 26591 (May 3, 2016) (SR-BatsBZX-2016-11).
    \13\ See Securities Exchange Act Release No. 78454 (August 2,
2016), 81 FR 52494 (August 8, 2016) (SR-BatsBZX-2016-46).
    \14\ See Securities Exchange Act Release No. 79222 (November 2,
2016) (SR-BatsBZX-2016-71).
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Proposal To Extend the Operation of the Program
    The Exchange established the Program in order to enhance liquidity
on the Exchange in certain ETPs listed on the Exchange (and thereby
enhance the Exchange's ability to compete as a listing venue) by
providing a mechanism by which ETP CLPs compete for part of a daily
quoting incentive on the basis of providing the most aggressive quotes
with the greatest amount of size. Such competition has the ability to
reduce spreads, facilitate the price discovery process, and reduce
costs for investors trading in such securities, thereby promoting
capital formation and helping the Exchange to compete as a listing
venue. The Exchange is proposing to extend the current pilot period for
the Program from November 4, 2016 to July 31, 2017 in order to allow
the Exchange to gather additional data related to the Program as the
Program continues to operate.
    Prior to the end of the pilot period ending July 31, 2017, the
Exchange will post a report relating to the Program (the ``Assessment
Report'') on its Web site three months before the end of the pilot
period or at the time it files to terminate the pilot, whichever comes
first. The proposed Assessment Report would list the program objectives
that are the focus of the pilot and, for each, provide (a) a
statistical analysis that includes evidence that is sufficient to
inform a reader about whether the program has met those objectives
during the pilot period, along with (b) a narrative explanation of
whether and how the evidence indicates the pilot has met the objective,
including both strengths and weaknesses of the evidence in this regard.
The Assessment Report also would include a discussion of (a) the
procedures used in selecting any samples that are used in constructing
tables or statistics for inclusion in the Assessment Report, (b) the
definitions of any variables and statistics reported in the tables,
including test statistics, (c) the statistical significance levels of
any test statistics and (d) other statistical or qualitative
information that may enhance the usefulness of the Assessment Report as
a basis for evaluating the performance of the program. The Assessment
Report would present statistics on product performance relative to the
performance of comparable or other suitable benchmark products
(including test statistics that permit the reader to evaluate the
statistical significance of any differences reported or discussed in
the report), along with information on the procedures that were used to
identify those comparable or benchmark products, the characteristics of
each comparable or benchmark products, the characteristics of each
product that is

the focus of the pilot, the procedures used in selecting the time
horizon of the sample and the sensitivity of reported statistics to
changes in the time horizon of the sample.
    As such, the Exchange believes that it is appropriate to extend the
current operation of the Program in order to allow the Exchange to
gather additional data related to the Program as the Program continues
to operate and the Exchange prepares the Assessment Report. Through
this filing, the Exchange seeks to extend the current pilot period of
the Program until July 31, 2017.
2. Statutory Basis
    The Exchange believes that its proposal 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.\15\ In particular,
the Exchange believes the proposed change furthers the objectives of
Section 6(b)(5) of the Act,\16\ in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system. The Exchange believes that
extending the pilot period for the Program is consistent with these
principles because the Program is reasonably designed to enhance quote
competition, improve liquidity in securities listed on the Exchange,
support the quality of price discovery, promote market transparency,
and increase competition for listings and trade executions, while
reducing spreads and transaction costs in such securities. Maintaining
and increasing liquidity in Exchange-listed securities will help raise
investors' confidence in the fairness of the market and their
transactions. Further, the Exchange believes that extending the pilot
period will allow the Exchange to gather additional data related to the
Program as the Program continues to operate in order to better assess
the effect of the Program on the public price discovery process and
market structure generally as part of its preparation of the Assessment
Report.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
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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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change
extends an established pilot period until July 31, 2017, thus allowing
the Program to enhance competition in both the listings market and in
competition for market makers. The Program will continue to promote
competition in the listings market by providing issuers with a vehicle
for paying the Exchange additional fees in exchange for incentivizing
tighter spreads and deeper liquidity in listed securities and allow the
Exchange to continue to compete with similar programs at Nasdaq Stock
Market LLC \17\ and NYSE Arca Equities, Inc.\18\
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    \17\ See Securities Exchange Act Release No. 69195 (March 20,
2013), 78 FR 18393 (March 26, 2013) (SR-NASDAQ-2012-137).
    \18\ See Securities Exchange Act Release No. 69335 (April 5,
2013), 78 FR 35340 (June 12, 2013) (SR-NYSEARCA-2013-34).
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    The Exchange also believes that extending the pilot period will
allow the Program to continue to enhance competition among market
participants by creating incentives for market makers to compete to
make better quality markets. By continuing to require that market
makers both meet the quoting requirements and also compete for the
daily financial incentives, the quality of quotes on the Exchange will
continue to improve. This, in turn, will attract more liquidity to the
Exchange and further improve the quality of trading in exchange-listed
securities participating in the Program, which will also act to bolster
the Exchange's listing business.

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

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

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

    Because the foregoing proposed rule change does not: (A)
Significantly affect the protection of investors or the public
interest; (B) impose any significant burden on competition; and (C) by
its terms, become operative for 30 days from the date on which it was
filed or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the Act \19\ and
paragraph (f)(6) of Rule 19b-4 thereunder.\20\ The Exchange has given
the Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission.
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    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4.
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative before 30 days from the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\21\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \21\ 17 CFR 240.19b-4(f)(6)(iii).
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    The Exchange has asked the Commission to waive the 30-day operative
delay. The Exchange asserts that waiver of the operative delay will
allow the Exchange to extend the Program prior to its expiration on
November 4, 2016, which will ensure that the Program continues to
operate uninterrupted while the Exchange and the Commission continue to
analyze data regarding the Program.\22\ The Exchange represents that
extending the pilot period will allow the Exchange to gather additional
data related to the Program to better assess the effect of the Program
on the public price discovery process and market structure, generally,
as part of its preparation of the Assessment Report. According to the
Exchange, prior to the end of the pilot period ending July 31, 2017,
the Exchange will post the Assessment Report on its Web site three
months before the end of the pilot period or at the time it files to
terminate the pilot, whichever comes first. Based on these
representations, the Commission believes that waiving the 30-day
operative delay is consistent with the protection of investors and the
public interest. Therefore, the Commission hereby waives the 30-day
operative delay and designates the proposed rule change to be operative
upon filing with the Commission.\23\
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    \22\ The Commission notes that, on November 4, 2016, the
Exchange filed a similar rule filing (SR-BatsBZX-2016-74) proposing
to extend the Program to July 31, 2017. The Exchange withdrew that
filing on November 7, 2016, and filed this proposed rule filing on
the same day.
    \23\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).

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    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: (1)
Necessary or appropriate in the public interest; (2) for the protection
of investors; or (3) otherwise in furtherance of the purposes of the
Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal 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 No. SR-BatsBZX-2016-75 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 No. SR-BatsBZX-2016-75. 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 will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-BatsBZX-2016-75 and should be
submitted on or before December 12, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-27892 Filed 11-18-16; 8:45 am]
 BILLING CODE 8011-01-P