[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22222-22225]
[FR Doc No: 2022-08018]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4626]

Lists of Bulk Drug Substances for Compounding: Office Stock Drugs
for Use in Nonfood-Producing Animals or Drugs for Use in Food-Producing
Animals or Free-Ranging Wildlife Species; Request for Nominations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for nominations.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing updated information for interested parties to nominate bulk
drug substances or renominate bulk drug substances that were previously
nominated without adequate supporting information, for inclusion on a
list of bulk drug substances for compounding certain animal drugs
without a patient specific prescription (i.e., office stock) for use in
nonfood-producing animals or for inclusion on a list of compounded
drugs for use as antidotes for food-producing animals or for use as
sedatives or anesthetics for free-ranging wildlife species, as
described in the guidance for industry #256 entitled ``Compounding
Animal Drugs from Bulk Drug Substances.'' Individuals may also comment
on bulk drug substances that have been reviewed by FDA and added to
these lists, or nominations that are currently under FDA review.

DATES: You may submit either electronic or written nominations and
comments at any time.

ADDRESSES: You may submit nominations and comments by any of the
following methods.

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 in the following ways:
     Mail/Hand Delivery/Courier (for 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-2018-N-4626 for ``Lists of Bulk Drug Substances for Compounding:
Office Stock Drugs for Use in Nonfood-Producing Animals or Drugs for
Use in Food-Producing Animals or Free-Ranging Wildlife Species.''
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
nominations and 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>.

FOR FURTHER INFORMATION CONTACT: Cindy Burnsteel, Office of
Surveillance and Compliance (HFV-200), Food and Drug Administration,
7519 Standish Pl., Rockville, Rockville, MD 20855,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Except with respect to the limited exemption provided by the
Federal Food, Drug, and Cosmetic Act (FD&C Act) described in the
following paragraph, statutory provisions applicable to manufactured
animal drugs under the FD&C Act also apply to animal drugs compounded
from bulk drug substances (also known as active pharmaceutical
ingredients (APIs)).\1\
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    \1\ FDA regulations define ``bulk drug substance'' and ``active
pharmaceutical ingredient'' as ``any substance that is intended for
incorporation into a finished drug product and is intended to
furnish pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention of disease, or
to affect the structure or any function of the body.'' The terms do
not include intermediates used in the synthesis of the substance. 21
CFR 207.1. ``Active ingredient'' is defined as ``any component that
is intended to furnish pharmacological activity or other direct
effect in the diagnosis, cure, mitigation, treatment, or prevention
of disease, or to affect the structure or any function of the body
of man or other animals. The term includes those components that may
undergo chemical change in the manufacture of the drug product and
be present in the drug product in a modified form intended to
furnish the specified activity or effect.'' 21 CFR 210.3(b)(7). Any
component other than an active ingredient is an ``inactive
ingredient.'' 21 CFR 210.3(b)(8). Inactive ingredients used in
compounded drug products commonly include flavorings, dyes,
diluents, or other excipients.
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    Sections 512(a)(4) and (5) of the FD&C Act (21 U.S.C. 360b(a)(4)
and (5)) provide a limited exemption from certain requirements for
compounded animal drugs made from already FDA-approved animal or human
drugs. Such use is considered an extralabel use. The FD&C Act provides
that a compounded drug is exempt from the approval requirements in
section 512(a) of the FD&C Act and requirements for adequate directions
for use in section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) if
it meets the conditions set out in the statute and the extralabel use
regulations at 21 CFR part 530.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of guidance for industry #256 entitled ``Compounding
Animal Drugs from Bulk Drug Substances'' (GFI #256).\2\ Animal drugs
compounded from bulk drug substances by pharmacists and veterinarians
violate the FD&C Act because they do not meet the requirements for
approval, current good manufacturing practice (CGMP) requirements, or
adequate directions for use. The guidance describes circumstances under
which FDA generally does not intend to take action against
veterinarians, or pharmacists in either State-licensed pharmacies or
Federal facilities, who compound animal drugs from bulk drug
substances. FDA does not intend to take action under sections 512(a),
502(f), and 501(a)(2)(B) and (a)(5) (21 U.S.C 351(a)(2)(B) and (a)(5))
of the FD&C Act under the circumstances described in GFI #256.
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    \2\ https://www.fda.gov/media/132567/download.
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II. Nominating Bulk Drug Substances

    In a Federal Register notice published November 19, 2019, FDA
established a public docket (FDA-2018-N-4626) so that interested
parties could nominate bulk drug substances to a list of bulk drug
substances for compounding office stock drugs for use in nonfood-
producing animals or antidotes for food-producing animals (the List)
and comment on nominated and evaluated bulk drug substances (the 2019
request for nominations notice).
    In conjunction with finalizing GFI #256, FDA is expanding
nominations to include drugs compounded for use as sedatives or
anesthetics for free-ranging wildlife species. We are also reorganizing
the List into two separate Lists:

1. The List of Bulk Drug Substances for Compounding Office Stock Drugs
for Use in Nonfood-Producing Animals \3\ and
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    \3\ Available at https://www.fda.gov/animal-veterinary/animal-drug-compounding/list-bulk-drug-substances-compounding-office-stock-drugs-use-nonfood-producing-animals.
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2. The List of Bulk Drug Substances for Compounding Drugs for Use in
Food-Producing Animals or Free-Ranging Wildlife Species \4\
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    \4\ Available at https://www.fda.gov/animal-veterinary/animal-drug-compounding/list-bulk-drug-substances-compounding-drugs-use-food-producing-animals-or-free-ranging-wildlife.

    Interested parties can nominate bulk drug substances to either
List, renominate bulk drug substances with adequate supporting
information that were previously nominated without adequate supporting
information, or comment on previously nominated bulk drug substances
that have been added to a List. This docket will remain open
indefinitely so that individuals may nominate and comment on bulk drug
substances at any time.

A. When will FDA include a bulk drug substance on either of the Lists?

    FDA intends to include a bulk drug substance on either of the Lists
when:
    1. There is no marketed FDA-approved, conditionally approved, or
indexed animal drug(s) that can be used as labeled to treat the
condition;
    2. There is no marketed FDA-approved, conditionally approved, or
indexed animal or human drug(s) with the same active ingredient(s) that
could be used in an extralabel manner to treat the condition; and
    3. FDA has not identified a significant safety concern specific to
the use of the bulk drug substance in animals.
    For bulk drug substances used to compound drugs intended as office
stock for nonfood-producing animals, in addition to 1 to 3 above:
    4. Urgent treatment with the compounded drug is necessary to avoid
animal suffering or death, or to protect public safety.
    For bulk drug substances used to compound drugs intended for use as
antidotes in food-producing animals or for use as sedatives or
anesthetics for free-ranging wildlife species, in addition to 1 to 3
above:
    5. There is sufficient scientific information for the prescribing
veterinarian to determine appropriate withdrawal, withholding, or
discard time(s) for meat, milk, eggs, or any food that might be derived
from the treated animal(s).

B. How do I submit a nomination for one of the Lists?

    You may submit nominations and comments to the docket through
https://www.regulations.gov. The information to support nominations can
be uploaded as attachments to your comment. The docket number is FDA-
2018-N-4626.
    You may submit written submissions to the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All submissions must include the Docket No. FDA-
2018-N-4626 for ``Lists of Bulk Drug Substances for Compounding: Office
Stock Drugs for Use in Nonfood-Producing Animals or Drugs for Use in
Food-Producing Animals or Free-Ranging Wildlife Species.''

C. What information should I submit with the nomination?

    You may nominate specific bulk drug substances for inclusion on
either of the Lists. Each bulk drug substance should be submitted to
the docket as its own, separate nomination. Submissions to the docket
containing more than one bulk drug substance will not be considered an
adequate nomination and will not be reviewed. Nominated substances that
do not meet the definition of a bulk drug substance will not be
evaluated for inclusion on a List.
    For FDA to evaluate a bulk drug substance for inclusion on a List,
you should submit the following information about the bulk drug
substance and the compounded animal drug in the nomination:
    1. Description of the Bulk Drug Substance:
    (a) Chemical name(s);
    (b) common name(s);
    2. Description of the Animal Drugs That Will be Compounded with the
Nominated Bulk Drug Substance:
    (a) Dosage form(s) into which the bulk drug substance will be
compounded (e.g., capsule, tablet, suspension);
    (b) strength(s) of the compounded drug(s); and
    (c) intended route(s) of administration of the compounded drug(s)
(e.g., oral, topical, injection, etc.).
    3. Information Requested for FDA to Evaluate Bulk Drug Substances
for Inclusion on a List:
    (a) The species the drug to be compounded with the nominated bulk
drug substance is intended to treat;
    (b) The disease or condition(s) the drug to be compounded with the
nominated bulk drug substance is intended to treat;
    (c) If there is a marketed FDA-approved, conditionally approved, or
indexed animal drug(s) that addresses the same condition(s) in the same
species, an explanation of why a compounded drug is necessary (e.g.,
why FDA-approved, conditionally approved, or indexed animal drug(s) is
not suitable for a particular animal population);
    (d) Confirmation that there is no marketed FDA-approved,
conditionally approved, or indexed drug(s) that could be prescribed to
treat the condition in the species that the drug compounded with the
nominated substance is intended to address;
    (e) If known by the nominator, if the bulk drug substance is an
active ingredient in a marketed FDA-approved, conditionally approved,
or indexed animal or human drug(s), an explanation of why the animal
drug cannot be compounded from the marketed FDA-approved, conditionally
approved, or indexed animal or human drug(s).
    (f) If known by the nominator, a description of any human user or
animal safety concerns associated with use of the nominated bulk drug
substance or finished compounded drug for the condition(s) in the
species that the compounded drug is intended to address. If there are
concerns, an explanation of why the concerns should not preclude
inclusion of that bulk drug substance on the List;
    (g) For compounded drugs intended as office stock for nonfood-
producing animals, an explanation of why the animal drug to be
compounded with the nominated bulk drug substance is important to be
available to the veterinarian for urgent treatment to avoid animal
suffering or death, e.g., why animal suffering or death will result if
treatment is delayed until a compounded animal drug can be obtained
pursuant to a prescription for an individually identified animal; and
    (h) For compounded drugs intended for use as antidotes to treat
toxicoses in food-producing animals, or as sedatives or anesthetics for
free-ranging wildlife species, relevant scientific literature or other
evidence that demonstrates that the prescribing veterinarian has a
basis for determining appropriate withdrawal, withholding, or discard
time(s) for meat, milk, eggs, or any food which might be derived from
the treated animal(s).
    4. Contact information for FDA should there be followup questions
regarding the nomination.

D. What about drugs that have been nominated for one of the Lists and
are still under review?

    FDA identifies those bulk drug substances that have been nominated
and under review at ``Bulk Drug Substances Currently Under Review.''
\5\ At this time, FDA generally intends to refrain from taking
enforcement action when these bulk drug substances currently under
review are used to compound a finished drug as described in the
nomination. Bulk drug substances will remain on ``Bulk Drug Substances
Currently Under Review'' only during FDA's review of their nomination.
If FDA completes its review and declines to place the bulk drug
substance on a List based on the information provided, FDA will place
the bulk drug substance on ``Bulk Drug Substances Reviewed and Not
Listed''; \6\ however, FDA will continue to accept and review any
adequate additional information submitted by any party that supports
the previously reviewed nomination. Should adequate additional
information be provided such that FDA can conduct further substantial
review, the bulk drug substance will again be placed on ``Bulk Drug
Substances Currently Under Review.''
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    \5\ Available at: https://www.fda.gov/animal-veterinary/animal-drug-compounding/bulk-drug-substances-currently-under-review.
    \6\ Available at https://www.fda.gov/animal-veterinary/animal-drug-compounding/bulk-drug-substances-reviewed-and-not-listed.
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E. What happens when FDA approves or indexes a drug made with a bulk
substance as described on one of the Lists?

    FDA intends to remove a bulk substance from a List if a finished
drug containing that substance in the appropriate dosage form and
strength is approved or indexed. Please see ``Bulk Drug Substances
Reviewed and Not Listed.''

F. What happens when FDA reviews a bulk drug substance and determines
that it cannot be placed on a List because of insufficient information
or because of other reasons (e.g., safety concerns)?

    Please see ``Bulk Drug Substances Reviewed and Not Listed'' for
those bulk drug substances that have been reviewed by FDA but are not
on either List.
    In a Federal Register notice published on May 19, 2015 (80 FR
28622), FDA invited all interested parties to nominate bulk drug
substances for inclusion on a list of bulk drug substances that could
be used by outsourcing facilities registered under the FD&C Act to
compound animal drugs under the conditions described in draft GFI #230,
``Compounding Animal Drugs from Bulk Drug Substances'' (announced in
the same issue of the

Federal Register (80 FR 28624)) (the 2015 request for nominations
notice).
    Although that draft guidance was subsequently withdrawn in November
2017, FDA received over 30 comments containing nominations for multiple
bulk drug substances in response to the 2015 request for nominations
notice. FDA's approach for determining whether to include a bulk drug
substance on the list described in the 2015 request for nominations
notice was substantially the same as the approach described above for
including a bulk drug substance on the ``List of Bulk Drug Substances
for Compounding Office Stock Drugs for Use in Nonfood-Producing
Animals'' in accordance with GFI #256. Therefore, and in keeping with
our intention as stated in the 2019 request for nomination notice, the
Agency is including certain of these nominated bulk drug substances on
this List. For other of these nominated bulk drug substances, finished
drugs containing the bulk drug substances in the appropriate dosage
form and strength have subsequently been approved; thus, these
nominated bulk drug substances will not appear on the List.
    Some bulk drug substances were nominated in response to the 2015
request for nominations notice with insufficient supporting
information. FDA subsequently searched for additional supporting
information for these bulk substances, conducted further review, and
added those with sufficient supporting information to the ``List of
Bulk Drug Substances for Compounding Office Stock Drugs for Use in
Nonfood-Producing Animals.''
    In addition, on its own initiative, FDA has identified certain bulk
drug substances that are used in minor species. Several have been
evaluated and are included on the ``List of Bulk Drug Substances for
Compounding Office Stock Drugs for Use in Nonfood-Producing Animals.''
Those identified bulk drug substances still under evaluation are
included on ``Bulk Drug Substances Currently Under Review.'' As FDA
continues to identify and evaluate bulk drug substances that are used
in minor species, we also encourage outside nominations.

    Dated: April 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08018 Filed 4-13-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Notices]
[Page 10692]
[FR Doc No: 2016-04528]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, March
3, 2016 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matter at the Closed Meeting.
    Chair White, as duty officer, voted to consider the items listed
for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Opinion;
    Adjudicatory matters;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: February 25, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-04528 Filed 2-26-16; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register: December 20, 2010 (Volume 75, Number 243)]
[Notices]
[Page 79435-79437]
[DOCID:fr20de10-978]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63542; File No. SR-NYSE-2010-79]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending NYSE Rule 123C(9)(a)(1) To Extend the Operation of a Pilot
Operating Pursuant to the Rule Until June 1, 2011

December 14, 2010.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on November 30, 2010, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE Rule 123C(9)(a)(1) to extend
the operation of a pilot operating pursuant to the Rule until June 1,
2011. The text of the proposed rule change is available at the
Exchange, the Commission's Public Reference Room, http://www.sec.gov,
and http://www.nyse.com.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend NYSE Rule 123C(9)(a)(1) to extend
the operation of a pilot that allows the Exchange to temporarily
suspend certain rule requirements at the close when extreme order
imbalances may cause significant dislocation to the closing price
(``Extreme Order Imbalances Pilot'' or ``Pilot'') \4\ until June 1,
2011.\5\ The Pilot is currently scheduled to expire on December 1,
2010.\6\
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    \4\ See Securities Exchange Act Release Nos. 59755 (April 13,
2009), 74 FR 18009 (April 20, 2009) (SR-NYSE-2009-18) (order
granting approval of the Pilot); 60809 (October 9, 2009), 74 FR
53532 (October 19, 2009) (SR-NYSE-2009-104) (extending the operation
of the Pilot to December 31, 2009); 61264 (December 31, 2009), 75 FR
1107 (January 8, 2010) (SR-NYSE-2009-131) (extending the operation
of the Pilot from December 31, 2009 to March 1, 2010); 61612 (March
1, 2010), 75 FR 10543 (March 8, 2010) (SR-NYSE-2010-11) (extending
the operation of the Pilot from March 1, 2010 to June 1, 2010);
62231 (June 4, 2010), 75 FR 33872 (June 15, 2010) (SR-NYSE-2010-42)
(extending the operation of the Pilot from June 1, 2010 to December
1, 2010).
    \5\ The Exchange notes that parallel changes are proposed to be
made to the rules of NYSE Amex LLC. See SR-NYSEAmex-2010-113.
    \6\ See Securities Exchange Act Release No. 62231 (June 4,
2010), 75 FR 33872 (June 15, 2010) (SR-NYSE-2010-42).
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Background
    Pursuant to NYSE Rule 123C(9)(a)(1), the Exchange may suspend NYSE
Rule 52 (Hours of Operation) to resolve an extreme order imbalance that
may result in a price dislocation at the close as a result of an order
entered into Exchange systems or represented to a Designated Market
Maker (``DMM'') orally at or near the close. The provisions of NYSE
Rule 123C(9)(a)(1) operate as the Extreme Order Imbalance Pilot.
    As a condition of the approval to operate the Pilot, the Exchange
committed to provide the Commission with information regarding: (i) How
often an NYSE Rule 52 temporary suspension pursuant to the Pilot was
invoked during the six months following its approval; and (ii) the
Exchange's determination as to how to proceed with technical
modifications to reconfigure Exchange systems to accept orders
electronically after 4 p.m.
    During the operation of the Pilot, the Exchange believed that the
systems modifications to allow Exchange systems to accept orders
electronically after 4 p.m. would not be as onerous as previously
believed when the Pilot was initially commenced. The Exchange completed
the system modifications necessary to accept orders electronically
after 4 p.m. and began the process of testing the modifications. The
Exchange therefore filed to extend the Extreme Order Imbalance Pilot
until the earlier of SEC approval to make such Pilot permanent or
December 1, 2010.\7\ At the time, the Exchange anticipated that its
quality assurance review process would be completed by December 1, 2010
and it would be able to operate under the new system. The quality
assurance review determined that additional testing was required in
order to assure the optimal functioning of the system modifications.
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    \7\ Id.
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Proposal To Extend the Operation of the Extreme Order Imbalance Pilot
    The Exchange established the Extreme Order Imbalance Pilot to
create a mechanism for ensuring a fair and orderly close when interest
is received at or near the close that could negatively affect the
closing transaction. The Exchange believes that this tool has proved
very useful to resolve an extreme order imbalance that may result in a
closing price dislocation at the close as a result of an order entered
into Exchange systems, or represented to a DMM orally at or near the
close.
    NYSE Rule 123C(9) was intended to be and has been invoked to
attract offsetting interest in rare circumstances where there exists an
extreme imbalance at the close such that a DMM is unable to close the
security without significantly dislocating the price. This is evidenced
by the fact that since the inception of the Pilot in April 2009, the
Exchange has invoked the provisions of NYSE Rule 123C(9)(a)(1) on only
five occasions, and only once since the pilot was last extended, in
June 2010.
    The Exchange proposes to extend the operation of the pilot for a
six-month period. At this time, the Exchange is completing testing of
functionality that would enable the electronic acceptance of orders
after 4 p.m. If the tests are successful, the Exchange expects to be
able to implement the new functionality by the end of December 2010. If
the Exchange does not believe it will be able to implement the new
functionality by the end of December 2010, it will work with the
Commission to set a new target date for implementation as soon as
practicable thereafter. In conjunction with the new functionality, the
Exchange plans to file a proposed rule change to amend Rule 123C(9) to
remove the limitation set forth in Rule 123C(9)(a)(1)(iii) that only
Floor brokers can represent interest after 4:00 p.m. and to make Rule
123C(9) permanent.\8\
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    \8\ See e-mail from Theodore Lazo, Vice President, Legal and
Government Affairs, NYSE Euronext, to David Liu, Senior Special
Counsel, Division of Trading and Markets, Commission, and Nathan
Saunders, Special Counsel, Division of Trading and Markets,
Commission, dated December 13, 2010 (``NYSE Euronext E-mail'').
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2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \9\ that an Exchange have rules that
are designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system and, in general, to protect
investors and the public interest. The Exchange believes that this
filing is consistent with these principles. Specifically, an extension
will allow the Exchange to determine the efficacy of providing any
additional functionality under this Pilot rule. The Pilot operates to
protect investors and the public interest by ensuring that the closing
price at the Exchange is not significantly dislocated from the last
sale price by virtue of an extreme order imbalance at or near the
close.
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    \9\ 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.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing 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 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 \10\ and Rule 19b-
4(f)(6)(iii) thereunder.\11\ The Exchange

has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The Exchange
has represented that it is completing testing of a functionality that
would enable the electronic acceptance of orders after 4 p.m., and if
successful, the Exchange expects to be able to implement the new
functionality by the end of December 2010. If the Exchange will not be
able to implement the new functionality by that date, it will work with
the Commission to set a new target date for implementation. The
Exchange also has represented that it plans to file a proposed rule
change to amend Rule 123C(9) to make the pilot permanent and to remove
the limitation that only Floor brokers can represent interest after 4
p.m.\12\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
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 filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Commission notes that the Exchange has satisfied
this requirement.
    \12\ See NYSE Euronext E-mail, supra note 8.
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because it will allow the pilot to continue uninterrupted, thereby
permitting offsetting interest represented by floor brokers to
alleviate extreme order imbalances occurring at the close until the
Exchange is able to allow the electronic submission of such interest
after 4 p.m. in such circumstances.\13\ Accordingly, the Commission
waives the 30-day operative delay requirement and designates the
proposed rule change operative upon filing with the Commission.
---------------------------------------------------------------------------

    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2010-79 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2010-79. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-NYSE-2010-79 and should be
submitted on or before January 10, 2011.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-31817 Filed 12-17-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43385-43386]
[FR Doc No: 2017-19607]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-M-4529 and FDA-2017-M-3899]

Medical Devices Regulated by the Center for Biologics Evaluation
and Research; Availability of Safety and Effectiveness Summaries for
Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
a list of premarket approval applications (PMAs) that have been
approved by the Center for Biologics Evaluation and Research (CBER).
This list is intended to inform the public of the availability of
safety and effectiveness summaries of approved PMAs through the
internet and the Agency's Dockets Management Staff.

ADDRESSES: You may submit comments 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 Nos.
FDA-2016-M-4529 and FDA-2017-M-3899 for ``Medical Devices Regulated by
the Center for Biologics Evaluation and Research; Availability of
Safety and Effectiveness Summaries for Premarket Approval
Applications.'' 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 Office between 9 a.m. and 4 p.m., Monday through Friday.
     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 Office. 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.gpo.gov/fdsys/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 office, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with sections 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting

reconsideration of an FDA action under Sec.  10.33(b) (21 CFR 10.33(b))
for notices announcing approval of a PMA begins on the day the notice
is placed on the internet. Section 10.33(b) provides that FDA may, for
good cause, extend this 30-day period. Reconsideration of a denial or
withdrawal of approval of a PMA may be sought only by the applicant; in
these cases, the 30-day period will begin when the applicant is
notified by FDA in writing of its decision.
    The regulations (21 CFR 814.44(d) and 814.45(d)) provide that FDA
publish a quarterly list of available safety and effectiveness
summaries of PMA approvals and denials that were announced during that
quarter. The following is a list of PMAs approved by CBER for which
safety and effectiveness summaries were placed on the internet from
October 1, 2016, through June 30, 2017. There were no denial actions
during this period. The list provides the manufacturer's name, the
product's generic name or the trade name, and the approval date.

   Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From October 1, 2016,
                                              Through June 30, 2017
----------------------------------------------------------------------------------------------------------------
         PMA No./Docket No.                 Applicant                 Trade name               Approval date
----------------------------------------------------------------------------------------------------------------
BP150318, FDA-2016-M-4529..........  Hologic, Inc...........  Aptima HIV-1 Quant Assay..  December 22, 2016.
BP160050, FDA-2017-M-3899..........  Roche Diagnostics......  Elecsys HIV Combi-PT......  June 21, 2017.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the internet may obtain the documents at
https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/default.htm.

    Dated: September 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19607 Filed 9-14-17; 8:45 am]
 BILLING CODE 4164-01-P


Dikegulac Sodium Registration Review Focus Meeting Held.

Summary

On July 24, 2014 the OPP registration review team met with representatives from USDA, PBI/Gordon and ArborSystems to discuss current use and usage, and sales data of dikegulac sodium. Dikegulac sodium is a growth regulator registered to prevent flowering and undesired fruit sets, to retard growth, and to promote lateral branching.  Currently, it is registered for use on hedges, shrubs, trees, and groundcovers in a number of residential, public, and industrial settings. The docket is scheduled to open in December 2014.

Participants

BEAD: Carl Chen, Cynthia Doucoure, Arnet Jones
EFED: Brian Anderson, Jean Holmes, Greg Orrick, Elyssa Arnold
HED: Bridgett Bobowiec, Yvonne Barnes
PRD RMIB2: Matthew Manupella, Cathryn Britton
RD: Heather Garvie
PBI/Gordon: Jim Kunstman
Arborsystems: Kim Davis
USDA: Ted Rogers

Agenda Topics

   1. BEAD
   * Discussion of current usage information ,  for dikegulac sodium including:
         o pounds a.i. applied or sold annually
         o average a.i. application rate
         o average # of applications per year
         o breakdown of use by application method
         o describe the primary uses (e.g., In nurseries? Greenhouses? Ornamentals in yards? Any particular species?)
         o Is use expected near water? Could use be restricted near water bodies?

   * What is the geographic distribution of dikegulac sodium use in the U.S.?
   * Given what appears to be relatively low usage, how important is this chemical to the nursery and floriculture sector in the U.S.?

   2. EFED
   * Are the registrants aware of any similar chemicals on the market? (e.g., chemicals that are expected to have similar toxicity profiles in particular)
   * Are the registrants aware of any fate or ecotox studies that have not been previously submitted to the Agency?
   * Has the registrant encountered any concerns from users about exposure of pollinators to dikegulac-sodium?