[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49587-49589]
[FR Doc No: 2021-19045]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92802; File No. SR-NYSE-2021-46]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Extend the Temporary Period for Specified Commentaries to Rules 7.35A
and 7.35C and Temporary Rule Relief in Rule 36.30

August 30, 2021.
    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 August 27, 2021, 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 extend the temporary period for specified
Commentaries to Rules 7.35A and 7.35C and temporary rule relief in Rule
36.30, to end on the earlier of a full reopening of the Trading Floor
facilities to DMMs or after the Exchange closes on December 31, 2021.
The proposed rule change is available on the Exchange's website at
www.nyse.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 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 extend the temporary period for specified
Commentaries to Rules 7.35A and 7.35C and temporary rule relief to Rule
36.30 to end on the earlier of a full reopening of the Trading Floor
facilities to DMMs or after the Exchange closes on December 31, 2021.
The current temporary period that these Rules are in effect ends on the
earlier of a full reopening of the Trading Floor facilities to DMMs or
after the Exchange closes on August 31, 2021.
Background
    To slow the spread of COVID-19 through social-distancing measures,
on March 18, 2020, the CEO of the Exchange made a determination under
Rule 7.1(c)(3) that, beginning March 23, 2020, the Trading Floor
facilities located at 11 Wall Street in New York City would close and
the Exchange would move, on a temporary basis, to fully electronic
trading.\4\ On May 14, 2020, the CEO of the Exchange made a
determination under Rule 7.1(c)(3) to reopen the Trading Floor on a
limited basis on May 26, 2020 to a subset of Floor brokers, subject to
safety measures designed to prevent the spread of COVID-19.\5\ On June
15, 2020, the CEO of the Exchange made a determination under Rule
7.1(c)(3) to begin the second phase of the Trading Floor reopening by
allowing DMMs to return on June 17, 2020, subject to safety measures
designed to prevent the spread of COVID-19.\6\ Consistent with these
safety measures, both DMMs and Floor broker firms continue to operate
with reduced staff on the Trading Floor.
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    \4\ Pursuant to Rule 7.1(e), the CEO notified the Board of
Directors of the Exchange of this determination. The Exchange's
current rules establish how the Exchange will function fully-
electronically. The CEO also closed the NYSE American Options
Trading Floor, which is located at the same 11 Wall Street
facilities, and the NYSE Arca Options Trading Floor, which is
located in San Francisco, CA. See Press Release, dated March 18,
2020, available here: https://ir.theice.com/press/press-releases/all-categories/2020/03-18-2020-204202110.
    \5\ See Securities Exchange Act Release No. 88933 (May 22,
2020), 85 FR 32059 (May 28, 2020) (SR-NYSE-2020-47) (Notice of
filing and immediate effectiveness of proposed rule change).
    \6\ See Securities Exchange Act Release No. 89086 (June 17,
2020) (SR-NYSE-2020-52) (Notice of filing and immediate
effectiveness of proposed rule change).
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Proposed Rule Change
    Beginning in March 2020, the Exchange modified its rules to add
Commentaries to Rules 7.35, 7.35A, 7.35B, and 7.35C and rule relief in
Rule 36.30,\7\ and has extended the expiration

date of such Commentaries several times.\8\ In July 2021, the
Commission approved the Exchange's proposals to make permanent several
of the rule changes that were the subject of those Commentaries.\9\ The
remaining Commentaries, specified below, are in effect until the
earlier of a full reopening of the Trading Floor facilities to DMMs or
after the Exchange closes on August 31, 2021:
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    \7\ See Securities Exchange Act Release Nos. 88413 (March 18,
2020), 85 FR 16713 (March 24, 2020) (SR-NYSE-2020-19) (amending Rule
7.35C to add Commentary .01); 88444 (March 20, 2020), 85 FR 17141
(March 26, 2020) (SR-NYSE-2020-22) (amending Rules 7.35A to add
Commentary .01, 7.35B to add Commentary .01, and 7.35C to add
Commentary .02); 88488 (March 26, 2020), 85 FR 18286 (April 1, 2020)
(SR-NYSE-2020-23) (amending Rule 7.35A to add Commentary .02); 88546
(April 2, 2020), 85 FR 19782 (April 8, 2020) (SR-NYSE-2020-28)
(amending Rule 7.35A to add Commentary .03); 88562 (April 3, 2020),
85 FR 20002 (April 9, 2020) (SR-NYSE-2020-29) (amending Rule 7.35C
to add Commentary .03); 88705 (April 21, 2020), 85 FR 23413 (April
27, 2020) (SR-NYSE-2020-35) (amending Rule 7.35A to add Commentary
.04); 88725 (April 22, 2020), 85 FR 23583 (April 28, 2020) (SR-NYSE-
2020-37) (amending Rule 7.35 to add Commentary .01); 88950 (May 26,
2020), 85 FR 33252 (June 1, 2020) (SR-NYSE-2020-48) (amending Rule
7.35A to add Commentary .05); 89059 (June 12, 2020), 85 FR 36911
(June 18, 2020) (SR-NYSE-2020-50) (amending Rule 7.35C to add
Commentary .04); 89086 (June 17, 2020), 85 FR 37712 (SR-NYSE-2020-
52) (amending Rules 7.35A to add Commentary .06, 7.35B to add
Commentary .03, 76 to add Supplementary Material 20, and
Supplementary Material .30 to Rule 36); 89925 (September 18, 2020)
(SR-NYSE-2020-75) (amending Rule 7.35 to add Commentary .02); and
90810 (December 29, 2020), 86 FR 335 (January 5, 2021) (SR-NYSE-
2020-109) (amending Rule 7.35A to add Commentary .07).
    \8\ See Securities Exchange Act Release No. 91778 (May 5, 2021)
86 FR 25902 (May 11, 2021) (SR-NYSE-2021-29) (Notice of filing and
immediate effectiveness of proposed rule change to extend the
temporary period for specified Commentaries to Rules 7.35, 7.35A,
7.35B, and 7.35C and temporary rule relief in Rule 36.30 to end on
the earlier of a full reopening of the Trading Floor facilities to
DMMs or after the Exchange closes on August 31, 2021). See also
Securities Exchange Act Release Nos. 90795 (December 23, 2020), 85
FR 86608 (December 30, 2020) (SR-NYSE-2020-106) (extending same to
end on the earlier of a full reopening of the Trading Floor
facilities to DMMs or after the Exchange closes on April 30, 2021);
90005 (September 25, 2020), 85 FR 61999 (October 2020) (SR-NYSE-
2020-78) (extending same to end on the earlier of a full reopening
of the Trading Floor facilities to DMMs or after the Exchange closes
on December 31, 2020); 89425 (July 30, 2020), 85 FR 47446 (August 5,
2020) (SR-NYSE-2020-63) (extending same to end on the earlier of a
full reopening of the Trading Floor facilities to DMMs or after the
Exchange closes on September 30, 2020); 89199 (June 30, 2020), 85 FR
40718 (July 7, 2020) (SR-NYSE-2020-56) (Notice of filing and
immediate effectiveness of proposed rule change to extend the
temporary period for Commentaries to Rules 7.35, 7.35A, 7.35B, and
7.35C; Supplementary Material .20 to Rule 76; and temporary rule
relief in Rule 36.30 to end on the earlier of a full reopening of
the Trading Floor facilities to DMMs or after the Exchange closes on
July 31, 2020); and 89368 (July 21, 2020), 85 FR 45272 (July 27,
2020) (SR-NYSE-2020-61) (Notice of filing and immediate
effectiveness of proposed rule change to lift the temporary
suspension to Rule 76 and delete Supplementary Material .20 to Rule
76).
    \9\ See Securities Exchange Act Release Nos. 92374 (July 9,
2021), 86 FR 37367 (July 15, 2021) (SR-NYSE-2020-89) (making
permanent the rule changes specified in Commentary .03 to Rule
7.35C); 92373 (July 12, 2021), 86 FR 37779 (July 16, 2021) (SR-NYSE-
2020-93) (making permanent the rule changes specified in
Commentaries .01 and .02 to Rule 7.35); and 92480 (July 23, 2021),
86 FR 40885 (July 29, 2021) (SR-NYSE-2020-95) (making permanent
certain rule changes specified in Commentaries .01 and .06 to Rule
7.35A and Commentaries .01 and .03 to Rule 7.35B).
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     Commentaries .01, .02, .03, .04, .05, and .07 to Rule
7.35A;
     Commentaries .01, .02, and .04 to Rule 7.35C; and
     Amendments to Rule 36.30.
    The first and second phases of the reopening of the Trading Floor
are subject to safety measures designed to prevent the spread of COVID-
19. To meet these safety measures, Floor brokers and DMM units that
have chosen to return to the Trading Floor are operating with reduced
staff. The Exchange is therefore proposing to extend Commentaries .01,
.02, .03, .04, 05, and .07 to Rule 7.35A, Commentaries .01, .02, and
.04 to Rule 7.35C. and the amendments to Rule 36.30 until such time
that there is a full reopening of the Trading Floor facilities to DMMs.
    The Exchange is not proposing any substantive changes to these
Rules.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\10\ in general, and furthers the objectives of Section 6(b)(5) of
the Act,\11\ in particular, 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.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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    To reduce the spread of COVID-19, the CEO of the Exchange made a
determination under Rule 7.1(c)(3) that beginning March 23, 2020, the
Trading Floor facilities located at 11 Wall Street in New York City
would close and the Exchange would move, on a temporary basis, to fully
electronic trading. On May 14, 2020, the CEO made a determination under
Rule 7.1(c)(3) that, beginning May 26, 2020, the Trading Floor would be
partially reopened to allow a subset of Floor brokers to return to the
Trading Floor. On June 15, 2020, the CEO made a determination under
Rule 7.1(c)(3) that, beginning June 17, 2020, DMM units may choose to
return a subset of staff to the Trading Floor.
    The Exchange believes that the proposed rule change would remove
impediments to and perfect the mechanism of a free and open market and
a national market system because the Trading Floor has not yet reopened
in full to DMMs or Floor brokers. Accordingly, the Exchange believes
that the temporary rule changes in effect pursuant to the Commentaries
to Rules 7.35A and 7.35C and amendments to Rule 36.30, which are
intended to be in effect during the temporary period while the Trading
Floor has not yet opened in full to DMMs, should be extended until such
time that there is a full reopening of the Trading Floor facilities to
DMMs. The Exchange is not proposing any substantive changes to these
Rules.
    The Exchange believes that, by clearly stating that this relief
will be in effect through the earlier of a full reopening of the
Trading Floor facilities to DMMs or the close of the Exchange on
December 31, 2021, market participants will have advance notice of the
temporary period during which the Commentaries to Rules 7.35A and 7.35C
and amendments to Rule 36.30 will be in effect.

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not designed to address any competitive issues but rather would extend
the period during which Commentaries .01, .02, .03, .04, 05, and .07 to
Rule 7.35A; Commentaries .01, .02, and .04 to Rule 7.35C; and
amendments to Rule 36.30 will be in effect. These Commentaries are
intended to be in effect during the temporary period while the Trading
Floor has not yet been opened in full to DMMs and Floor brokers and
currently expire on August 31, 2021. Because the Trading Floor has not
been opened in full to DMMs, the Exchange proposes to extend the
temporary period for these temporary rules to end on the earlier of a
full reopening of the Trading Floor facilities to DMMs or after the
Exchange closes on December 31, 2021.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \12\ and Rule 19b-4(f)(6) thereunder.\13\
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 and Rule
19b-4(f)(6)(iii) thereunder.
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    \12\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \13\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\15\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing.
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    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
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    The Commission believes that waiver of the operative delay is
consistent with the protection of investors and the public interest
because it will allow the rules discussed above to remain in effect
during the temporary period during which the Trading Floor has not yet
been reopened in full to DMMs because of health precautions related to
the Covid-19 pandemic. Accordingly, the Commission hereby waives the
30-day operative delay and designates the proposal operative upon
filing.\16\
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    \16\ For purposes only of accelerating the operative date of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \17\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \17\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2021-46 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-NYSE-2021-46. 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 website (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 website 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 the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSE-2021-46 and should be submitted on
or before September 24, 2021.
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    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-19045 Filed 9-2-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 31 (Tuesday, February 15, 2022)]
[Rules and Regulations]
[Page 8413]
[FR Doc No: 2022-03155]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2021-0914]

Special Local Regulation; Marine Events Within the Eleventh Coast
Guard District--Mark Hahn Memorial 300 Mile PWC Endurance Race

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Mark Hahn Memorial 300 Mile
Personal Watercraft (PWC) Endurance Race special local regulation on
the waters of Lake Havasu, Arizona from February 26 through February
27, 2022. This special local regulation is necessary to provide for the
safety of the participants, crew, sponsor vessels, and general users of
the waterway. During the enforcement period, persons and vessels are
prohibited from entering into, transiting through, or anchoring within
this regulated area unless authorized by the Captain of the Port, or
his designated representative.

DATES: The regulations in 33 CFR 100.1102 will be enforced from 7 a.m.
until 6 p.m., each day from February 26, 2022 through February 27, 2022
for the location described in Item No. 14 in Table 1 to Sec.  100.1102.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Lieutenant Commander John
Santorum, Waterways Management, U.S. Coast Guard Sector San Diego, CA;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulations in 33 CFR 100.1102 for the Mark Hahn Memorial 300
Mile PWC Endurance Race on Lake Havasu, AZ for the location described
in Table 1 to Sec.  100.1102, Item No. 14 of that section, from 7 a.m.
to 6 p.m. on February 26, 2022 through February 27, 2022. This action
is being taken to provide for the safety of life on the navigable
waterway during the race. Our regulation for recurring marine events on
the Colorado River, between Davis Dam (Bullhead City, Arizona) and
Headgate Dam (Parker, Arizona), Sec.  100.1102, Table 1 to Sec.
100.1102, Item No. 14, specifies the location of the regulated area for
the Mark Hahn Memorial 300 PWC Endurance Race, which encompasses
portions of Lake Havasu. Under the provisions of Sec.  100.1102,
persons and vessels are prohibited from entering into, transiting
through, or anchoring within this regulated area unless authorized by
the Captain of the Port, or his designated representative. The Coast
Guard may be assisted by other Federal, State, or local law enforcement
agencies in enforcing this regulation.
    In addition to this document in the Federal Register, the Coast
Guard will provide the maritime community with advance notification of
this enforcement period via the Local Notice to Mariners and local
advertising by the event sponsor.
    If the Captain of the Port Sector San Diego or his designated
representative determines that the regulated area need not be enforced
for the full duration stated on this document, he or she may use a
Broadcast Notice to Mariners or other communications coordinated with
the event sponsor to grant general permission to enter the regulated
area.

    Dated: February 9, 2022.
T.J. Barelli,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2022-03155 Filed 2-14-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6574-6575]
[FR Doc No: 2022-02348]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1041]

Immunogenicity Information in Human Prescription Therapeutic
Protein and Select Drug Product Labeling--Content and Format; 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 the Agency) is
announcing the availability of a draft guidance for industry entitled
``Immunogenicity Information in Human Prescription Therapeutic Protein
and Select Drug Product Labeling--Content and Format.'' This draft
guidance provides recommendations for incorporating clinically relevant
immunogenicity information into the labeling of products having
immunogenicity assessments. Appropriate inclusion and consistent
placement of immunogenicity information in the Prescribing Information
helps to make clinically relevant information accessible to the health
care practitioner and promotes the safe and effective use of
prescription drug and biological products. When finalized, the
recommendations in this guidance will supersede the immunogenicity
labeling-specific recommendations in the guidances for industry
entitled ``Labeling for Biosimilar Products'' and ``Clinical
Pharmacology Section of Labeling for Human Prescription Drug and
Biological Products--Content and Format.''

DATES: Submit either electronic or written comments on the draft
guidance by April 5, 2022 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-2021-D-1041 for ``Immunogenicity Information in Human Prescription
Therapeutic Protein and Select Drug Product Labeling--Content and
Format.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Eric Brodsky, Center for Drug
Evaluation and Research, Food and Drug

Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6485, Silver
Spring, MD 20993,<PHONE_NUMBER>; or Stephen Ripley, 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

    FDA is announcing the availability of a draft guidance for industry
entitled ``Immunogenicity Information in Human Prescription Therapeutic
Protein and Select Drug Product Labeling--Content and Format.''
    Evaluation of a therapeutic protein product's and certain select
drug products' immunogenicity (e.g., risk of developing anti-drug
antibodies, including neutralizing antibodies) and its potential
clinical impact generally plays an important role in the assessment of
the product's safety and effectiveness for each proposed indication.
Because some, but not all, anti-drug antibodies have been associated
with safety concerns or loss of effectiveness, FDA believes that
presenting immunogenicity information in a consistent manner would
enable health care practitioners to more easily differentiate products
associated with anti-drug antibodies having clinical effect(s) from
products with anti-drug antibodies that do not have a clinically
meaningful effect on pharmacokinetics, pharmacodynamics, safety, or
effectiveness.
    This draft guidance recommends the use of a dedicated
Immunogenicity subsection (subsection 12.6) under the CLINICAL
PHARMACOLOGY section. Information and statements to include in this
subsection (e.g., data on anti-drug antibody incidence, clinical
pharmacologic effects of anti-drug antibodies) are described in the
draft guidance, along with recommended content to include in other
sections of the labeling (e.g., summary of anti-drug antibody-
associated effects on safety and/or effectiveness in the WARNINGS AND
PRECAUTIONS, ADVERSE REACTIONS, and/or CLINICAL STUDIES sections, as
applicable). The labeling recommendations are based on: (1) Adequacy of
the methodology for detection of anti-drug antibodies, (2) sufficiency
of available data to draw clinical conclusions, and (3) whether the
anti-drug antibodies have clinically significant effect(s). In addition
to recommendations on presentation of known immunogenicity information,
this draft guidance also provides recommendations for consistently
stating when such information is unknown, if appropriate. The draft
guidance also provides procedural information, including
recommendations for updating immunogenicity information in the
Prescribing Information of applicable approved products.
    When finalized, this guidance will supersede the immunogenicity
labeling-specific recommendations from the guidance for industry
entitled ``Clinical Pharmacology Section of Labeling for Human
Prescription Drug and Biological Products--Content and Format''
(available at https://www.fda.gov/media/74346/download). When
finalized, this guidance will also supersede the recommendations in
section IV.C.3., ADVERSE REACTIONS, Immunogenicity, of the guidance for
industry entitled ``Labeling for Biosimilar Products'' (available at
https://www.fda.gov/media/96894/download), including the statement
``Immunogenicity information for therapeutic protein products is
usually placed in a subsection in the ADVERSE REACTIONS section
entitled Immunogenicity'' and statements recommended for inclusion as
the first paragraph in the ADVERSE REACTIONS subsection that precedes
the immunogenicity data. FDA has verified the website addresses as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Immunogenicity Information in Human Prescription Therapeutic Protein
and Select Drug Product Labeling--Content and Format.'' 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

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections 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 for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001. The collections of information in 21 CFR part 600
have been approved under OMB control number 0910-0308. The collections
of information in 21 CFR part 601 have been approved under OMB control
number 0910-0338. The collections of information in 21 CFR 201.56 and
201.57 have been approved under OMB control number 0910-0572. The
collections of information related to pharmacology data have been
approved under OMB control number 0910-0014. The collections of
information submitting biologics license applications under section
351(k) of the Public Health Service Act have been approved under OMB
control number 0910-0719.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: January 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02348 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 157 (Monday, August 15, 2011)]
[Notices]
[Pages 50521-50522]
[FR Doc No: 2011-20634]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65063; File No. SR-NASDAQ-2011-110]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Regarding a Clerical Change to NASDAQ Options Market Rules

August 9, 2011.
    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 August 2, 2011, The NASDAQ Stock Market LLC (the ``Exchange'' or
``NASDAQ'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to renumber a subsection of NASDAQ Options
Market Chapter VI, Section 10. The text of the proposed rule change is
below. Proposed new language is in italics; proposed deletions are in
brackets.\3\ NASDAQ proposes to implement the proposed rule change
immediately.
---------------------------------------------------------------------------

    \3\ Changes are marked to the rules of the Exchange found at
http://nasdaqomxbx.cchwallstreet.com.
---------------------------------------------------------------------------

* * * * *
    Chapter VI, Trading Systems.
* * * * *
Section 10. Book Processing.
    System orders shall be executed through the Nasdaq Book Process set
forth below:
    (1)-(5) No Change.
    ([5]6) Exception: Anti-Internalization--Quotes and orders entered
by Options Market Makers using the same market participant identifier
will not be executed against quotes and orders entered on the opposite
side of the market by the same market maker using the same identifier.
In such a case, the System will cancel the oldest of the quotes or
orders back to the entering party prior to execution.
* * * * *

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 aspects of such
statements.

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

1. Purpose
    NASDAQ proposes to make a clerical correction to the NASDAQ
rulebook. Specifically, NASDAQ proposes to renumber NASDAQ Options
Market Chapter VI, Section 10. On June 14, 2011, NASDAQ submitted a
proposed rule filing to adopt anti-internalization functionality for
registered market makers on the NASDAQ Options Market. The Commission
published the notice of filing and immediate effectiveness on June 23,
2011.\4\ Although the rule change was effective upon filing, the change
is not operative until August 1, 2011. The Exchange is renumbering this
previously approved rule because another rule change has been approved
that uses the same number. There is no change to the substance of the
rule.
---------------------------------------------------------------------------

    \4\ Securities Exchange Act Release No. 64696 (June 17, 2011),
76 FR 36950 (June 23, 2011) (SR-NASDAQ-2011-083).
---------------------------------------------------------------------------

2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\5\ in general, and with Section
6(b)(5) of the Act,\6\ in particular, in that the proposal 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 regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, 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 proposed rule change
makes a minor clerical change to an existing NASDAQ rule.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    Pursuant to Section 19(b)(3)(A) of the Act \7\ and Rule 19b-4(f)(3)
thereunder,\8\ NASDAQ has designated this proposal as one that is
concerned solely with the administration of the self-regulatory
organization. Accordingly, NASDAQ

believes that its proposal should become immediately effective.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-110 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-NASDAQ-2011-110. 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 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 available publicly. All submissions should refer to
File Number SR-NASDAQ-2011-110 and should be submitted on or before
September 6, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-20634 Filed 8-12-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Rules and Regulations]
[Pages 12505-12506]
[FR Doc No: 2017-04186]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-8834; Airspace Docket No. 16-ACE-9]

Amendment of Class E Airspace; Mapleton, IA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies Class E airspace extending upward from
700 feet above the surface at James G. Whiting Memorial Field Airport,
Mapleton, IA. Decommissioning of the Mapleton non-directional radio
beacon (NDB), cancellation of NDB approaches, and implementation of
area navigation (RNAV) procedures have made this action necessary for
the safety and management of Instrument Flight Rules (IFR) operations
at the airport.

DATES: Effective 0901 UTC, June 22, 2017. The Director of the Federal
Register approves this incorporation by reference action under Title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11A, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies Class E airspace at James G. Whiting Memorial Field
Airport, Mapleton, IA.

History

    On September 8, 2016, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM), (81 FR 62040) Docket No. FAA-
2016-8834, to amend Class E airspace at James G. Whiting Memorial Field
Airport, Mapleton, IA. Interested parties were invited to participate
in this rulemaking effort by submitting written comments on the
proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11A, Airspace Designations and
Reporting Points, dated August 3, 2016,

and effective September 15, 2016. FAA Order 7400.11A is publicly
available as listed in the ADDRESSES section of this document. FAA
Order 7400.11A lists Class A, B, C, D, and E airspace areas, air
traffic service routes, and reporting points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 modifies Class E airspace extending upward from 700 feet above
the surface within a 6.6-mile radius (increased from the 6.3-mile
radius) of James G. Whiting Memorial Field Airport, Mapleton, IA, with
an extension southwest of the airport from the 6.6-mile radius to 10.3
miles. The segment extending 10 miles northeast of the airport is
removed.
    Airspace reconfiguration is necessary due to the decommissioning of
the Mapleton NDB, cancellation of NDB approaches, and implementation of
RNAV procedures at the airport and for the safety and management of the
standard instrument approach procedures for IFR operations at the
airport.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE IA E5 Mapleton, IA [Amended]

Mapleton, James G. Whiting Memorial Field Airport, IA
    (Lat. 42[deg]10'42'' N., long. 95[deg]47'37'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of James G. Whiting Memorial Field Airport,
and within 4 miles each side of the 204[deg] bearing from the
airport extending from the 6.6-mile radius to 10.3 miles southwest
of the airport.

    Issued in Fort Worth, Texas, on February 22, 2017.
Walter Tweedy
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-04186 Filed 3-3-17; 8:45 am]
BILLING CODE 4910-13-P


                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460

                                                	OFFICE OF CHEMICAL SAFETY AND
                                                           POLLUTION PREVENTION

MEMORANDUM

Date: 	March 29, 2018

SUBJECT:	Dithiopyr: Tier I Update Review of Human Incidents and Epidemiology for Draft Risk Assessment

PC Code: 128994
DP Barcode: D445956
Decision No.: 528348
Registration No.: NA
Petition No.: NA
Regulatory Action: NA
Risk Assessment Type: NA
Case No.: NA
TXR No.: NA
CAS No.: 97886-45-8
MRID No.: NA
40 CFR: NA
		              									Ver.Apr.08

FROM:	Shanna Recore, Industrial Hygienist
		Elizabeth Evans, Environmental Protection Specialist
		Toxicology and Epidemiology Branch
		Health Effects Division (7509P)

THROUGH:	David J. Miller, Acting Branch Chief
		Toxicology and Epidemiology Branch
		Health Effects Division (7509P)

TO: 		Monica Hawkins, Risk Assessor
		Risk Assessment Branch VI
		Health Effects Division (7509P)
			and
            V. Dutch, Chemical Review Manager
		Risk Management & Implementation Branch 5
		Pesticide Re-evaluation Division (7508P)

Summary and Conclusions

Dithiopyr incidents were previously reviewed in 2013 (E. Evans and S. Recore, D415250, 09/24/13).  At that time, based on the low severity and frequency of cases reported to both Incident Data System (IDS) and NIOSH Sentinel Event Notification System for Occupational Risk (SENSOR)-Pesticides, there was not a risk of concern that warranted further analysis.

In the current IDS analysis from January 1, 2013 to March 1, 2018, two cases involving a single active ingredient and four cases involving multiple active ingredients were reported to Main IDS; there were 36 cases reported to Aggregate IDS.  A query of SENSOR-Pesticides 1998-2014 identified 25 cases involving dithiopyr.

The Agricultural Health Study (AHS) is a federally-funded study that evaluates associations between pesticide exposures and cancer and other health outcomes and represents a collaborative effort between the US National Cancer Institute (NCI), National Institute of Environmental Health Sciences (NIEHS), CDC's National Institute of Occupational Safety and Health (NIOSH), and the US EPA.  Dithiopyr is not included in the AHS, and therefore this study does not provide information for this report.

Based on the continued low frequency and severity of dithiopyr incidents reported to both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time.  The Agency will continue to monitor the incident data and if a concern is triggered, additional analysis will be conducted.

Detailed Review

 ACTION REQUESTED

Dithiopyr is being considered under the FQPA-mandated Registration Review program established to review, on a 15-year cycle, pesticides for which a Re-registration Eligibility Decision has been made.  HED's RAB VI has requested that TEB conduct a Tier I Update review summary of recent incident data from IDS and SENSOR as per standard protocol under the Agency's Registration Review Program. One component of the Agency's Registration Review Program is consideration of human incident data.  In conjunction with a human health risk assessment based on other data sources, such human incident data can assist the Agency in better defining and characterizing the risk of pesticides/pesticide products.

It is important to remember that reports of adverse health effects allegedly due to a specific pesticide exposure (i.e., an "incident") are largely self-reported and therefore, generally speaking, neither exposure to a pesticide or reported symptom (or the connection between the two) is validated or otherwise confirmed.  Typically, causation cannot be determined based on incident data, and such data should be interpreted with caution.  Nonetheless, incident information can be an important source of feedback to the Agency:  incidents of severe outcome, or a suggested pattern or trend among less severe incidents, can signal the Agency to further investigate a particular chemical or product. Epidemiology studies can also be useful and relate the risk of disease, e.g., cancer, and exposure to an agent such as a pesticide product in the general population or specific sub-groups like pesticide applicators.

 BACKGROUND

Dithiopyr is a pre-emergent herbicide for control of grasses and small-seeded broad leaf weeds. Its primary use in is to control crabgrass in turf, ornamentals, and flowerbeds.

For this evaluation, both OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredient dithiopyr (PC Code:128994).  The purpose of the database search is to identify potential patterns in the frequency and severity of the health effects attributed to dithiopyr exposure.

 RESULTS/DISCUSSION
 IDS (Incident Data System)

OPP's IDS includes reports of alleged human health incidents from various sources, including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants, other federal and state health and environmental agencies, and individual consumers. Since 1992, OPP has compiled these reports in IDS.  IDS contains reports from across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report.

IDS records incidents in one of two modules: Main IDS and Aggregate IDS:

 Main IDS generally contains incidents resulting in higher severity outcomes and provides more detail with regard to case specifics.  This system stores incident data for death, major and moderate incidents, and it includes information about the location, date and nature of the incident.  Main IDS incidents involving only one pesticide are considered to provide more certain information about the potential effects of exposure from the pesticide.

 Aggregate IDS contains incidents resulting in less severe human incidents (minor, unknown, or no effects outcomes). These are reported by registrants only as counts in what are aggregate summaries.
For the Main IDS for the five years from January 1, 2013 to March 1, 2018, there were six cases reported that involved the active ingredient dithiopyr.  Of these six case reports, two incidents involved the single active ingredient dithiopyr (only). These incidents were classified as moderate severity.  The other four dithiopyr incidents reported involved multiple active ingredients.
For Aggregate IDS for the five years from January 1, 2012 to April 28, 2017, there were 36 incidents reported involving dithiopyr.  Thirty-three of these incidents were classified as minor severity and three had no or unknown severity.

 SENSOR-Pesticides

The Center for Disease Control's National Institute for Occupational Safety and Health (CDC/NIOSH) manages a pesticide surveillance program and database entitled the Sentinel Event Notification System for Occupational Risk (SENSOR)-Pesticides.  This database includes pesticide illness case reports from multiple states from 1998-2014.   Currently participating states are: California, Florida, Illinois, Louisiana, Michigan, Nebraska, New Mexico, North Carolina, Oregon, Texas and Washington. The participating states for a given year vary depending on state and federal funding for pesticide surveillance.

Cases of pesticide-related illnesses in the SENSOR-Pesticides database are ascertained from a variety of sources, including: reports from local Poison Control Centers, state Department of Labor workers' compensation claims when reported by physicians, reports from state Departments of Agriculture, and physician reports to state Departments of Health. Although both occupational and non-occupational incidents are included in the database, the SENSOR coordinators primarily focus their follow-up case investigation efforts on the occupational pesticide incidents.  The SENSOR-Pesticides coordinator at the state Department of Health will follow-up with cases and work to obtain medical records in order to verify exposure scenario, symptoms, severity, and health outcome.  Using standardized protocol and case definitions, SENSOR-Pesticides coordinators enter the incident interview description provided by the case, medical report, physician and patient into the database.

All SENSOR-Pesticide cases must report a minimum of two health effects in order to be included in the aggregate database that EPA uses for incident analyses.  Evidence for each case is evaluated for its causal relationship between exposure and illness based on the NIOSH case classification index.  About 98% of SENSOR-Pesticides cases are classified as definite, probable, or possible, and 2% of the cases are classified as suspicious.  Unlikely, asymptomatic, and unrelated cases, as well as those with insufficient information, are not included in the SENSOR-Pesticides database.

A query of SENSOR-Pesticides from 1998-2014 identified a total of 25 cases involving dithiopyr (pc code 128994).  Seven cases involved a single active ingredient and 18 cases involved multiple active ingredients.  Fifteen cases occurred in occupational settings and ten cases were residential.  Six cases were moderate in severity and 19 cases were low in severity.

The most frequently implicated product, involved in nine of the 25 dithiopyr incident reports in SENSOR, was Roundup Ready-to-use Extended Control Weed & Grass Killer 1 Plus Weed, EPA Reg. No. 71995-21, an actively registered product that contains 0.03% dithiopyr and 1% glyphosate.

The following summarizes the exposure scenarios for all 25 dithiopyr cases:
 Eleven cases were exposed while applying a product containing dithiopyr.
 Seven cases involved various (non-application) handling exposure scenarios, including:
 Four cases involved exposure during the vehicle transportation of the chemical.
 Three of these eight cases were retail workers at lawn and garden centers were exposed when handling products purchased by consumers.  One of the three retail exposures was a cashier who got some of the pesticide in her eyes while checking out a customer, another retail worker was stacking bags of product when exposed, and a store manager was splashed in the eye when disposing of a returned product.
 Two cases were exposed and made ill due to their close proximity to applications that were taking place; one case was in their home and the other case was working at a university.
 One case was working on a golf course that was treated with Roundup (product has 0.03% dithiopyr and 1% glyphosate).
 One case was a child that grabbed a product from a shelf at a retail establishment and sprayed himself in the eye.
 In three cases the exposure scenarios were unknown.
Health effects reported among cases primarily involved the nervous system, followed by ocular and dermal effects.  The specific symptoms most reported were headache and eye pain/irritation.

 Agricultural Health Study (AHS)

The AHS is a federally-funded study that evaluates associations between pesticide exposures and cancer and other health outcomes and represents a collaborative effort between the US National Cancer Institute (NCI), National Institute of Environmental Health Sciences (NIEHS), CDC's National Institute of Occupational Safety and Health (NIOSH), and the US EPA. The AHS participant cohort includes more than 89,000 licensed commercial and private pesticide applicators and their spouses from Iowa and North Carolina. Enrollment occurred from 1993  -  1997, and data collection is ongoing. The AHS maintains a list of publications resulting from AHS studies. If there are AHS findings in the published literature relevant to a pesticide undergoing registration review, the Agency will ensure these findings are considered in the problem formulation/scoping phase of the registration review process and, if appropriate, fully reviewed in the risk assessment phase of the process.  Dithiopyr is not included in the AHS, and therefore this study does not provide information for this report.

 CONCLUSION

Based on the continued low frequency and severity of dithiopyr incidents reported to both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time.  The Agency will continue to monitor the incident data and if a concern is triggered, additional analysis will be conducted.


[Federal Register Volume 85, Number 210 (Thursday, October 29, 2020)]
[Notices]
[Pages 68613-68614]
[FR Doc No: 2020-24043]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: Notice is hereby given, pursuant to the provisions of
the Government in the Sunshine Act, Public Law 94-409, the Securities
and Exchange Commission will hold an Open Meeting on Monday, November
2, 2020, at 10 a.m.

PLACE: The meeting will be held via remote means and/or at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS: This meeting will begin at 10:00 a.m. (ET) and will be open to
the public via audio webcast only on the Commission's website at http://www.sec.gov.

MATTERS TO BE CONSIDERED: The Commission will consider whether to adopt
rule amendments to facilitate capital formation and increase
opportunities for investors by expanding access to capital for small
and medium-sized businesses and entrepreneurs across the United States.
Specifically, the Commission will consider whether to adopt rule
amendments to simplify, harmonize, and improve certain aspects of the
framework for exemptions from registration under the Securities Act of
1933 to promote capital formation while preserving or enhancing
important investor protections and reducing complexities in the exempt
offering framework that may impede access to investment opportunities
for investors and access to capital for businesses and entrepreneurs.

    Dated: October 26, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-24043 Filed 10-27-20; 11:15 am]
BILLING CODE 8011-01-P