[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Proposed Rules]
[Pages 13289-13292]
[FR Doc No: C1-2015-01666]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314 and 320

[Docket No. FDA-2011-N-0830]
RIN 0910-AF97

Abbreviated New Drug Applications and 505(b)(2) Applications

Correction

    In Proposed Rule Document 2015-01666, pages 6801-6896, publishing
in the Issue of Friday, February 6, 2015, make the following
corrections:
    1. On page 6807, in the second column in Table 1, the heading
should read:

------------------------------------------------------------------------
                                                 Proposed Changes  See
                                                section of this document
                                                     (identified in
                                                 parentheses)  for more
                                                  detailed information
                                                 regarding the proposed
                                                         change

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

    2. On page 6808, in Table 1, the second column should read:

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

314.95(e)....................................  Documentation of Timely
                                                Sending and Receipt of
                                                Notice of Paragraph IV
                                                Certification,
                                                including:
                                               a. Acceptable methods of
                                                sending notice of
                                                paragraph IV
                                                certification; and
                                               b. Amendment documenting
                                                timely sending and
                                                confirmation of receipt
                                                of notice of paragraph
                                                IV certification.
                                               (II.D.4).
------------------------------------------------------------------------

    3. On pages 6818-6819, in Table 2, the second row should read:

------------------------------------------------------------------------
                                              Proposed revisions to
          Current regulations                      regulations
------------------------------------------------------------------------
General Requirements (Sec.               General Requirements (Sec.
 314.53(c)(1))                            314.53(c)(1))
Patent information will not be accepted   Patent information
 unless it is complete and submitted on   will not be accepted unless it
 the appropriate forms (Form FDA 3542a    is submitted on the
 or 3542).                                appropriate forms (Form FDA
                                          3542a or 3542) and contains
                                          the information required in
                                          Sec.   314.53(c)(2).
------------------------------------------------------------------------
Reporting Requirements (Sec.             Reporting Requirements (Sec.
 314.53(c)(2))                            314.53(c)(2))
The required information and             The required information and
 verification in Sec.   314.53(c)(2)(i)   verification in Sec.
 and (c)(2)(ii) includes:                 314.53(c)(2)(i) and (c)(2)(ii)
 Information on whether the       includes:
 patent has been submitted previously     Information on whether
 for the NDA                              the patent is a re-issued
 Information on whether the       patent of a patent submitted
 drug substance patent claims a           previously for listing for the
 polymorph that is the same active        NDA or supplement.
 ingredient that is described in the      Information on whether
 pending NDA or supplement, and, if so,   the drug substance patent
 has test data described in Sec.          claims only a polymorph that
 314.53(b)(2)                             is the same active ingredient
                                          that is described in the
                                          pending NDA or supplement,
                                          and, if so, has test data
                                          described in Sec.
                                          314.53(b)(2).
------------------------------------------------------------------------

    4. On pages 6838-6839, in Table 8, the second row should read:

------------------------------------------------------------------------
                                              Proposed revisions to
          Current regulations                      regulations
------------------------------------------------------------------------
Documentation of receipt of notice       Documentation of timely sending
 (Sec.  Sec.   314.52(e) and 314.95(e))   and receipt of notice (Sec.
                                          Sec.   314.52(e) and
                                          314.95(e))
 Applicant must amend its         Applicant must amend
 505(b)(2) application or ANDA to         its 505(b)(2) application or
 document the date of receipt of the      ANDA to provide documentation
 notice of paragraph IV certification     of the date of receipt of the
 by each patent owner and NDA holder      notice of paragraph IV
 provided the notice.                     certification by each patent
 Applicant must include a copy    owner and NDA holder provided
 of the return receipt or other similar   the notice.
 evidence of the date the notification   --FDA will accept as adequate
 was received.                            documentation of the date of
-- FDA will accept as adequate            receipt a return receipt,
 documentation of the date of receipt a   signature proof of delivery by
 return receipt or a letter               a designated delivery service,
 acknowledging receipt by the person      or a letter acknowledging
 provided the notice.                     receipt by the person provided
 An applicant may rely on         notice.
 another form of documentation only if   -- Amendment must be submitted
 FDA has agreed to such documentation     to FDA within 30 days after
 in advance.                              the last date on which notice
                                          was received by a patent owner
                                          or NDA holder.
                                          Amendment also must
                                          include adequate documentation
                                          that notice was sent on a date
                                          that complies with the
                                          timeframe required by Sec.
                                          314.52(b) or (d) or Sec.
                                          314.95(b) or (d), as
                                          applicable.
                                            --FDA will accept a copy of
                                             the registered mail
                                             receipt, certified mail
                                             receipt, or receipt from a
                                             designated delivery
                                             service, as adequate
                                             documentation of the date
                                             of delivery.
                                          An ANDA applicant's
                                          amendment must include a dated
                                          printout of the Orange Book
                                          entry for the RLD that
                                          includes the patent that is
                                          the subject of the paragraph
                                          IV certification.
                                          An applicant may rely
                                          on another form of
                                          documentation only if FDA has
                                          agreed in advance.
------------------------------------------------------------------------

    5. On pages 6842-6843, in Table 9, the third row should read:

------------------------------------------------------------------------
                                              Proposed revisions to
          Current regulations                      regulations
------------------------------------------------------------------------
After a Finding of Infringement (Sec.    After a Finding of Infringement
 Sec.   314.50(i)(6)(i) and               (Sec.  Sec.   314.50(i)(6)(i)
 314.94(a)(12)(viii)(A))                  and 314.94(a)(12)(viii)(A))
 Change from paragraph IV         Change from paragraph
 certification to paragraph III           IV certification to paragraph
 certification required after a final     III certification required
 judgment is entered finding the patent   after court enters final
 to be infringed.                         decision from which no appeal
 Provision applies if patent      has been or can be taken, or
 infringement action initiated within     signs settlement order or
 45 days of receipt of notice of          consent decree with a finding
 paragraph IV certification.              of infringement (unless the
                                          patent also is found invalid).
                                          An applicant may instead
                                          provide a statement under Sec.
                                            314.50(i)(1)(iii) or Sec.
                                          314.94(a)(12)(iii) with
                                          respect to a method-of-use
                                          patent if the 505(b)(2)
                                          application or ANDA is amended
                                          such that the applicant is no
                                          longer seeking approval for a
                                          method of use claimed by the
                                          patent.
                                          Provision applies if
                                          patent infringement action
                                          initiated after receipt of
                                          notice of paragraph IV
                                          certification, irrespective of
                                          whether the action is brought
                                          within the 45-day period.
------------------------------------------------------------------------

    6. On pages 6859-6861, in Table 12, the third, sixth, and seventh
rows should read:

------------------------------------------------------------------------
                                              Proposed revisions to
          Current regulations                      regulations
------------------------------------------------------------------------
Date of approval letter (Sec.            Timing of approval based on
 314.107(b)(1))                           patent certification or
                                          statement (Sec.
                                          314.107(b)(1))
 Except as provided in Sec.       If none of the reasons
 314.107(b)(3), (b)(4), and (c),          in Sec.   314.125 or Sec.
 approval will become effective on the    314.127 for refusing to
 date FDA issues an approval letter if    approve the application apply,
 the applicant certifies that:            and none of the reasons in
(i) there are no relevant patents; or     Sec.   314.107(d) for delaying
(ii) the patent information has not       approval apply, the 505(b)(2)
 been submitted to FDA; or                application or ANDA may be
(iii) the relevant patent has expired;    approved--
 or                                      (i) Immediately, if the
(iv) the relevant patent is invalid,      applicant certifies that:
 unenforceable, or will not be           (A) the patent information has
 infringed.                               not been submitted to FDA; or
                                         (B) the relevant patent has
                                          expired; or
                                         (C) the relevant patent is
                                          invalid, unenforceable, or
                                          will not be infringed, except
                                          as provided in Sec.
                                          314.107(b)(3) and (c), and the
                                          45-day period provided for in
                                          section 505(c)(3)(C) and
                                          505(j)(5)(B)(iii) of the FD&C
                                          Act has expired; or
                                              (D) there are no relevant
                                               patents.
                                         (ii) Immediately, if the
                                          applicant submits an
                                          appropriate statement
                                          explaining that a method-of-
                                          use patent does not claim an
                                          indication or other condition
                                          of use for which it is seeking
                                          approval.
------------------------------------------------------------------------
Disposition of patent litigation (Sec.   Disposition of patent
  314.107(b)(3)(i))                       litigation (Sec.
                                          314.107(b)(3)(i))
 (A) Except as provided in Sec.   (A) Except as provided
   314.107(b)(3)(ii) through              in Sec.   314.107(b)(3)(ii)
 (b)(3)(iv), if                           through (b)(3)(viii), if, with
-- applicant submits a paragraph IV       respect to patents for which
 certification; and                       required information was
-- patent owner or its representative     submitted before the date on
 or the exclusive patent licensee         which the 505(b)(2)
 brings suit for patent infringement      application or ANDA was
 within 45 days of receipt by the         submitted to FDA (excluding an
 patent owner of the notice of            amendment or supplement),
 paragraph IV certification,             --applicant submits a paragraph
Approval may be made effective 30         IV certification; and
 months after the date of the receipt    --patent owner or the exclusive
 of the notice of paragraph IV            patent licensee brings suit
 certification by the patent owner or     for patent infringement within
 by the exclusive licensee (or their      45 days of receipt of the
 representatives) unless the court has    notice of paragraph IV
 extended or reduced the period; or       certification, 505(b)(2)
 (B) If the patented drug         application, or ANDA may be
 product qualifies for 5-year             approved 30 months after the
 exclusivity, and                         later of the date of the
-- patent owner or its representative     receipt of the notice of
 or the exclusive patent licensee         certification by any owner of
 brings suit for patent infringement      the listed patent or by the
 during the 1-year period beginning 4     NDA holder who is an exclusive
 years after the date the patented drug   patent licensee (or their
 was approved and within 45 days of       representatives) unless the
 receipt by the patent owner of the       court has extended or reduced
 notice of paragraph IV certification,    the period; or
Approval may be made effective at the     (B) If the patented
 expiration of 7\1/2\ years from the      drug product qualifies for 5-
 date of NDA approval for the patented    year exclusivity, and
 drug product.                           --patent owner or its
                                          representative or the
                                          exclusive patent licensee
                                          brings suit for patent
                                          infringement during the 1-year
                                          period beginning 4 years after
                                          the date the patented drug was
                                          approved and within 45 days of
                                          receipt of the notice of
                                          paragraph IV certification,
                                         the 505(b)(2) application or
                                          ANDA may be approved at the
                                          expiration of 7\1/2\ years
                                          from the date of NDA approval
                                          for the patented drug product.
------------------------------------------------------------------------
Disposition of patent litigation (Sec.   Disposition of patent
  314.107(b)(3)(ii)-(b)(3)(iv))           litigation (Sec.
                                          314.107(b)(3)(ii)-(b)(3)(viii)

If before the expiration of the 30-      If before the expiration of the
 month period, or 7\1/2\ years where      30-month period, or 7\1/2\
 applicable:                              years where applicable:
 (ii) the court issues a final    (ii) the district
 order that the patent is invalid,        court decides that the patent
 unenforceable, or not infringed,         is invalid, unenforceable, or
 approval may be made effective on:       not infringed (including any
-- the date the court enters judgment;    substantive determination that
 (iii) the court issues a final   there is no cause of action
 order or judgment that the patent has    for patent infringement or
 been infringed, approval may be made     invalidity), the 505(b)(2)
 effective on:                            application or ANDA may be
-- the date the court determines that     approved on:
 the patent will expire or otherwise     --(A) the date on which the
 orders                                   court enters judgment
 (iv) the court grants a          reflecting the decision; or
 preliminary injunction prohibiting the  --(B) the date of a settlement
 applicant from engaging in the           order or consent decree signed
 commercial manufacture or sale of the    and entered by the court
 drug product until the court decides     stating that the patent that
 the issues of patent validity and        is the subject of the
 infringement, and if the court later     certification is invalid or
 decides that the patent is invalid,      not infringed.
 unenforceable, or not infringed,         (iii) the district
 approval may be made effective on:       court decides that the patent
-- the date the court enters a final      has been infringed and the
 order or judgment that the patent is     judgment is appealed, the
 invalid, unenforceable, or not           505(b)(2) application or ANDA
 infringed.                               may be approved on:
                                         --(A) the date on which the
                                          mandate is issued by the court
                                          of appeals entering judgment
                                          that the patent is invalid or
                                          not infringed; or
                                         --(B) the date of a settlement
                                          order or consent decree signed
                                          and entered by the court of
                                          appeals stating that the
                                          patent is invalid or not
                                          infringed.
                                          (iv) the district
                                          court decides that the patent
                                          has been infringed and the
                                          judgment is not appealed or is
                                          affirmed, the 505(b)(2)
                                          application or ANDA may be
                                          approved no earlier than the
                                          date specified by the district
                                          court in an order under 35
                                          U.S.C. 271(e)(4)(A).
                                             (v) the district
                                             court grants a preliminary
                                             injunction prohibiting the
                                             applicant from engaging in
                                             the commercial manufacture
                                             or sale of the drug product
                                             until the court decides the
                                             issues of patent validity
                                             and infringement:
                                              -- if the court later
                                               decides the patent is
                                               invalid, unenforceable,
                                               or not infringed, the
                                               505(b)(2) application or
                                               ANDA may be approved per
                                               Sec.   314.107(b)(3)(ii).
                                              --if the court decides
                                               that the patent has been
                                               infringed, the 505(b)(2)
                                               application or ANDA may
                                               be approved per Sec.
                                               314.107(b)(3)(iii) or
                                               (b)(3)(iv), as
                                               applicable.
                                             (vi) the patent
                                             owner or the exclusive
                                             patent licensee (or their
                                             representatives) agrees in
                                             writing that the 505(b)(2)
                                             application or ANDA may be
                                             approved any time on or
                                             after the date of the
                                             consent, approval may be
                                             granted on or after that
                                             date.
                                             (vii) the court
                                             enters an order requiring
                                             the 30-month or 7\1/2\-year
                                             period to be terminated,
                                             the 505(b)(2) application
                                             or ANDA may be approved in
                                             accordance with the court's
                                             order.
                                             (viii) the court
                                             enters an order of
                                             dismissal, with or without
                                             prejudice, without a
                                             finding of infringement,
                                             the 505(b)(2) application
                                             or ANDA may be approved on
                                             or after the date of the
                                             order.
------------------------------------------------------------------------

[FR Doc. C1-2015-01666 Filed 3-12-15; 8:45 am]
 BILLING CODE 1505-01-D


[Federal Register Volume 81, Number 1 (Monday, January 4, 2016)]
[Notices]
[Pages 129-131]
[FR Doc No: 2015-32987]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76777; File No. SR-EDGA-2015-45]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
Fees for Use of EDGA Exchange, Inc.

December 28, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 15, 2015, EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-members of the Exchange pursuant to EDGA Rules
15.1(a) and (c) (``Fee Schedule'') to adopt fees for the recently
adopted ALLB routing strategy.
---------------------------------------------------------------------------

    \5\ The term ``Member'' is defined as ``any registered broker or
dealer, or any person associated with a registered broker or dealer,
that has been admitted to membership in the Exchange. A Member will
have the status of a ``member'' of the Exchange as that term is
defined in Section 3(a)(3) of the Act.'' See Exchange Rule 1.5(n).
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

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

1. Purpose
    The Exchange proposes to adopt fees for the ALLB routing strategy.
In sum, ALLB is a routing option under which the order checks the
System \6\ for available shares and is then sent to the BATS Exchange,
Inc. (``BZX''), BATS Y-Exchange, Inc. (``BYX''), and the EDGX Exchange,
Inc. (``EDGX'' collectively with the Exchange, BZX, and BYX, the ``BGM
Affiliated Exchanges'').\7\ Specifically, an order subject to the ALLB
routing option would execute first against liquidity on the EDGA
Book.\8\ Any remainder would then be routed to BZX, BYX, and/or EDGX in
accordance with the System routing table.\9\
---------------------------------------------------------------------------

    \6\ The term ``System'' is defined as ``the electronic
communications and trading facility designated by the Board through
which securities orders of Users are consolidated for ranking,
execution and, when applicable, routing away.'' See Exchange Rule
1.5(cc).
    \7\ See Exchange Rule 11.11(g)(7). See also Securities Exchange
Act Release No. 76455 (November 17, 2015), 80 FR 73009 (November 23,
2015) (SR-EDGA-2015-42).
    \8\ The term ``EDGA Book'' is defined as ``the System's
electronic file of orders.'' See Exchange Rule 1.5(d).
    \9\ The term ``System routing table'' refers to the proprietary
process for determining the specific trading venues to which the
System routes orders and the order in which it routes them. See
Exchange Rule 11.11(g).
---------------------------------------------------------------------------

    The Exchange now proposes to adopt three new fee codes, AX, AY, and
AZ and related fees for the ALLB routing strategy. These fee codes
would enable

the Exchange to pass through the rate that BATS Trading, Inc. (``BATS
Trading''), the Exchange's affiliated routing broker-dealer, would be
charged for routing orders to BZX, BYX, and EDGA.\10\ Each of the
proposed fee codes are described as follows:
---------------------------------------------------------------------------

    \10\ Orders using the ALLB routing option that execute on the
Exchange would be subject to the Exchange's standard fees and
rebates, unless the Member achieves a volume tiered reduced fee or
enhanced rebate.
---------------------------------------------------------------------------

     Fee Code AX. Order routed to EDGX using the ALLB routing
strategy would yield fee code AY and be charged a fee of $0.00290 per
share in securities priced at or above $1.00. Orders yielding fee code
AX in securities priced below $1.00 would be charged a fee of 0.30% of
the transaction's dollar value.
     Fee Code AY. Order routed to BYX using the ALLB routing
strategy would yield fee code AY and receive a rebate of $0.00150 per
share in securities priced at or above $1.00. Orders yielding fee code
AY in securities priced below $1.00 would be charged a fee of 0.10% of
the transaction's dollar value.
     Fee Code AZ. Order routed to BZX using the ALLB routing
strategy would yield fee code AZ and be charged a fee of $0.00300 per
share in securities priced at or above $1.00. Orders yielding fee code
AZ in securities priced below $1.00 would be charged a fee of 0.30% of
the transaction's dollar value.
    BATS Trading will pass through the above rates to the Exchange and
the Exchange, in turn, will pass through that exact rate to its
Members. The proposed rates would enable the Exchange to equitably
allocate its costs among all Members utilizing the ALLB routing
strategy.
Implementation Date
    The Exchange proposes to implement this amendment to its Fee
Schedule on January 4, 2016, but the proposed fee codes and their
associated rates will not be available until January 7, 2016, the date
upon which it announced to Members that it would implement the ALLB
routing strategy.\11\
---------------------------------------------------------------------------

    \11\ See BATS Announces ALLB Routing Option, available at http://cdn.batstrading.com/resources/release_notes/2015/BATS-ALL-BATS-Routing-Strategy-Release-Schedule-Updated.pdf. The Exchange notes
that the Fee Schedule's date was amended to January 4, 2016 in file
no. SR-EDGA-2015-46 (December 8, 2015).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\12\ in general, and
furthers the objectives of Section 6(b)(4),\13\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities. The Exchange believes that its proposed rates represent an
equitable allocation of reasonable dues, fees, and other charges among
Members and other persons using its facilities because the Exchange
does not levy additional fees or offer additional rebates for orders
that it routes to BZX, BYX, and EDGX through BATS Trading. The Exchange
believes that its proposed pass through rate for orders that yield fee
codes AX, AY or AZ is equitable and reasonable because it accounts for
the rate that BATS Trading would be subject to for orders it routes and
are executed on EDGX, BYX, and BZX. In addition, the proposal allows
the Exchange to pass-through to its Members the rate for orders that
are routed to EDGX, BYX, and BZX using the ALLB routing strategy.
Furthermore, the Exchange notes that routing through BATS Trading is
voluntary. Lastly, the Exchange also believes that the proposed
amendment is non-discriminatory because it applies uniformly to all
Members.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f.
    \13\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    This proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. The Exchange does not believe that this change represents a
significant departure from previous pricing offered by the Exchange or
pricing offered by the Exchange's competitors. Additionally, Members
may opt to disfavor the Exchange's pricing if they believe that
alternatives offer them better value. Accordingly, the Exchange does
not believe that the proposed changes will impair the ability of
Members or competing venues to maintain their competitive standing in
the financial markets. The Exchange believes that its proposal to pass
through the rates that BATS Trading would be subject to for orders
routing to EDGX, BYX, and BZX using the ALLB routing strategy to
Members would increase intermarket competition because it offers
customers an alternative means to route orders to those venues. In
addition, the proposed pricing would not provide any advantage to Users
when routing to EDGX, BYX or BYX as compared to other methods of
routing or connectivity available to Users by the Exchange because the
proposed rates are identical to what the Member would be subject to if
it routed to those venues directly. The Exchange believes that its
proposal would not burden intramarket competition because the proposed
rate would apply uniformly to all Members.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \14\ and paragraph (f) of Rule 19b-4
thereunder.\15\ 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.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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 No. SR-EDGA-2015-45 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-EDGA-2015-45. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the

submission, all subsequent amendments, all written statements with
respect to the proposed rule change that are filed with the Commission,
and all written communications relating to the proposed rule change
between the Commission and any person, other than those that may be
withheld from the public in accordance with the provisions of 5 U.S.C.
552, will be available for Web site viewing and printing in the
Commission's Public Reference Room, 100 F Street NE., Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing will also be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File No. SR-EDGA-2015-45 and should be
submitted on or before January 25, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-32987 Filed 12-31-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: January 9, 2008 (Volume 73, Number 6)]
[Rules and Regulations]
[Page 1508-1512]
[DOCID:fr09ja08-6]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0093]; FRL-8344-3]

Mesotrione; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
mesotrione in or on berry, group 13; flax, seed; cranberry;
lingonberry; millet, grain; millet, forage; millet, hay; and millet,
straw. Syngenta Crop Protection requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 9, 2008. Objections and
requests for hearings must be received on or before March 10, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0093. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kathryn V. Montague, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any

questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0093 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before March 10, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2006-0093, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of April 26, 2006 (71 FR 24695) (FRL-8063-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F7023) by Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC.
The petition requested that 40 CFR 180.571 be amended by establishing
tolerances for residues of the herbicide mesotrione, 2-[4-
(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, in or on flax,
meal/seed at 0.01 parts per million (ppm); millet, forage/grain at 0.01
parts per million (ppm); millet, hay/straw at 0.02 ppm; Berry group and
cranberry at 0.01 ppm. That notice referenced a summary of the petition
prepared by Syngenta Crop Protection, the registrant, which is
available to the public in the docket, http://www.regulations.gov.

There were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, to harmonize
with the Food and Feed Commodity Vocabulary (http://www.epa.gov/opphed01/foodfeed/index.htm
) EPA has amended the commodity listing to

read: Flax, seed at 0.01 ppm; millet, grain at 0.01 ppm; millet, forage
at 0.01 ppm; millet, hay at 0.02 ppm; millet, straw at 0.02 ppm; berry,
group 13 at 0.01 ppm, lingonberry at 0.01 ppm and cranberry at 0.02 ppm

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for residues of mesotrione on flax, seed at 0.01 ppm; millet, grain at
0.01 ppm; millet, forage at 0.01 ppm; millet, hay at 0.02 ppm; millet,
straw at 0.02 ppm; berry group 13 at 0.01 ppm, lingonberry at 0.01 ppm
and cranberry at 0.02 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by mesotrione as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov.
 The referenced document is available in the docket

established by this action, which is described under ADDRESSES, and is
identified as ``Mesotrione: Petition 6F7023 Human Health Risk
Assessment for Proposed Section 3 New Uses on Berries, Cranberries,
Millet, Flax, Grain Sorghum (Section 18)'' in that docket.
Additionally, mesotrione toxicological data are discussed in the final
rule published in the Federal Register of June 21, 2001 (66 FR 33187)
(FRL-6787-7).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes

used for risk assessment. Uncertainty/safety factors (UFs) are used in
conjunction with the LOC to take into account uncertainties inherent in
the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. Safety is assessed for acute and chronic risks by
comparing aggregate exposure to the pesticide to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD are calculated by dividing the LOC by all applicable UFs.
Short-term, intermediate-term, and long-term risks are evaluated by
comparing aggregate exposure to the LOC to ensure that the margin of
exposure (MOE) called for by the product of all applicable UFs is not
exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for mesotrione used for
human risk assessment can be found at http://www.regulations.gov in

document ``Mesotrione: Petition 6F7023 Human Health Risk Assessment for
Proposed Section 3 New Uses on Berries, Cranberries, Millet, Flax,
Grain Sorghum (Section 18)'' at page 16 in docket ID number EPA-HQ-OPP-
2006-0093.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to mesotrione, EPA considered exposure under the petitioned-
for tolerances as well as all existing mesotrione tolerances in (40 CFR
180.571). EPA assessed dietary exposures from mesotrione in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
mesotrione; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculutre (USDA) 1994-1996, and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed all foods for which there are tolerances
were treated and contain tolerance-level residues.
    iii. Cancer. Mesotrione was negative for carcinogenicity in feeding
studies in rats and mice and was classified as ``not likely'' to be a
human carcinogen. Therefore, a quantitative exposure assessment to
evaluate cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for mesotrione in drinking water. Because
the Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate characteristics of
mesotrione. Further information regarding EPA drinking water models
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.

    Based on the First Index Reservoir Screening Tool (FIRST) for dry
harvested cranberry and a modified Interim Rice Model for wet harvested
cranberry and Screening Concentration in Ground Water (SCI-GROW)
models, the estimated environmental concentrations (EECs) of mesotrione
for chronic exposures are estimated to be 4.7 parts per billion (ppb)
for surface water and 0.18 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 4.7 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Mesotrione is not registered for use on any sites that would result
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Mesotrione, pyrasulfotole, isoxaflutole and topramezone belong to a
class of herbicides that inhibit the liver enzyme 4-
hydroxyphenylpyruvate dioxygenase (HPPD), which is involved in the
catabolism (metabolic breakdown) of tyrosine (an amino acid derived
from proteins in the diet). Inhibition of HPPD can result in elevated
tyrosine levels in the blood, a condition called tyrosinemia. HPPD-
inhibiting herbicides have been found to cause a number of toxicities
in laboratory animal studies including ocular, developmental, liver and
kidney effects. Of these toxicities, it is the ocular effect (corneal
opacity) that is highly correlated with the elevated blood tyrosine
levels. In fact, rats dosed with tyrosine alone show ocular opacities
similar to those seen with HPPD inhibitors. Although the other
toxicities may be associated with chemically-induced tyrosinemia, other
mechanisms may also be involved.
    There are marked differences among species in the ocular toxicity
associated with inhibition of HPPD. Ocular effects following treatment
with HPPD inhibitor herbicides are seen in the rat but not in the
mouse. Monkeys also seem to be recalcitrant to the ocular toxicity
induced by HPPD inhibition. One explanation of this species-specific
response in ocular opacity may be related to the species differences in
the clearance of tyrosine. A metabolic pathway exists to remove
tyrosine from the blood that involves a liver enzyme called tyrosine
aminotransferase (TAT). In contrast to rats where ocular toxicity is
observed following exposure to HPPD-inhibiting herbicides, mice and
humans are unlikely to achieve the levels of plasma tyrosine necessary
to produce ocular opacities because the activity of TAT in these
species is much greater compared to rats. HPPD inhibitors (e.g.,
nitisinone) are used as an effective therapeutic agent to treat
patients suffering from rare genetic diseases of tyrosine catabolism.
Treatment starts in childhood but is often sustained throughout
patient's lifetime. The human experience indicates that a therapeutic
dose (1 milligrams/kilogram/day (mg/kg/day) dose) of nitisinone has an
excellent safety record in infants, children and adults and that
serious adverse health outcomes have not been observed in a population
followed for approximately a decade. Rarely, ocular effects are seen in
patients with high plasma tyrosine

levels; however, these effects are transient and can be readily
reversed upon adherence to a restricted protein diet. This indicates
that an HPPD inhibitor in and of itself cannot easily overwhelm the
tyrosine-clearance mechanism in humans.
    Therefore, exposure to environmental residues of HPPD-inhibiting
herbicides are unlikely to result in the high blood levels of tyrosine
and ocular toxicity in humans due to an efficient metabolic process to
handle excess tyrosine. The Agency continues to study the complex
relationships between elevated tyrosine levels and biological effects
in various species. Nonetheless, as a worst case scenario, EPA has
assessed aggregate exposure to mesotrione based on ocular effects in
rats. For similar reasons, a semi-quantitative screening cumulative
assessment was conducted using the rat ocular effects and 100% crop
treated information. The results of this screening analysis did not
indicate a concern. In the future, assessments of HPPD-inhibiting
herbicides will consider more appropriate models and cross species
extrapolation methods. Therefore, EPA has not conducted cumulative risk
assessment with other HPPD inhibitors. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA safety factor. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is quantitative
evidence of increased susceptibility of the young in the oral prenatal
developmental toxicity studies in rats, mice, and rabbits and in the
multi-generation reproduction study in mice and lack of a developmental
neurotoxicity study in mice. Quantitative evidence of increased
susceptibility was not demonstrated in the multi-generation
reproduction study in rats. However, no NOAEL was established for
parental or offspring systemic toxicity. There is evidence of a
qualitative increase in susceptibility since the tyrosinemia observed
in the young was much more severe than that observed in the adults.
    3. Conclusion. There are 2 deficiencies in the mesotrione toxicity
database. First, a Developmental Neurotoxicity Study has been required
to assess the effects on the developing nervous/ocular system from
exposed to mesotrione. Second, the mouse 2-generation reproduction
study, on which the Reference Dose/ Population Adjusted Dose (RfD/PAD)
is based failed to identify a NOAEL. In light of this data gap, the
necessity of a reliance on a LOAEL to calculate the RfD/PAD, and the
quantitative and qualitative evidence of increased susceptibility of
the young discussed above, EPA is raising the 10X FQPA safety factor to
the value of 30X.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
    1. Acute risk. There were no effects observed in oral toxicity
studies including developmental toxicity studies in rats and rabbits
that could be attributable to a single dose (exposure). Therefore,
mesotrione is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
mesotrione from food and water will utilize 51% of the cPAD for the
population group (All Infants (< 1 year old)). There are no residential
uses for mesotrione that result in chronic residential exposure to
mesotrione.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Mesotrione is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water.
    4. Intermediate-term risk Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Mesotrione is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
    5. Aggregate cancer risk for U.S. population. Mesotrione is
classified as a ``not likely'' to be carcinogenic in humans based on
the results of a carcinogenicity study in mice and the combined chronic
toxicity and carcinogenicity study in the rat. Therefore, mesotrione is
not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to mesotrione residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-pressure liquid
chromatography fluorescence detector (HPLC/FLD)) is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

     There are no CODEX, Canadian, or Mexican tolerances/Maximum
Residue Levels for mesotrione residues for the proposed crops.

V. Conclusion

    Therefore, the tolerance is established for residues of mesotrione,
2-[4- (methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, in or on
flax, seed at 0.01 ppm; millet, grain at 0.01 ppm; millet, forage at
0.01 ppm; millet, hay at 0.02 ppm; millet, straw at 0.02 ppm; berry
group 13 at 0.01 ppm, lingonberry at 0.01 ppm and cranberry at 0.02
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and

Budget (OMB) has exempted these types of actions from review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993). Because this rule has been exempted from
review under Executive Order 12866, this rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 28, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.571 is amended by alphabetically adding the following
commodities in the table in paragraph (a) to read as follows:

Sec.  180.571  Mesotrione; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Berry, group 13......................................               0.01
                                * * * * *
Cranberry............................................               0.02
Flax, seed...........................................               0.01
Lingonberry..........................................               0.01
Millet, grain........................................               0.01
Millet, forage.......................................               0.01
Millet, hay..........................................               0.02
Millet, straw........................................               0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-181 Filed 1-8-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 84, Number 40 (Thursday, February 28, 2019)]
[Notices]
[Pages 6793-6795]
[FR Doc No: 2019-03507]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3631]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with the
standards for the growing, harvesting, packing, and holding of produce
for human consumption.

DATES: Submit either electronic or written comments on the collection
of information by April 29, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 29, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2018-D-3631 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Standards for the Growing,
Harvesting, Packing, and Holding of Produce for Human Consumption.''
Received comments, those filed in a timely manner (see ADDRESSES), 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.
     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.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, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption; 21 CFR Part 112

OMB Control Number 0910-0816--Revision

    To minimize the risk of serious adverse health consequences or
death from consumption of contaminated produce, we have established
science-based minimum standards for the safe growing, harvesting,
packing, and holding of produce, meaning fruits and vegetables grown
for human consumption. The standards are codified in part 112 (21 CFR
part 112) and set forth procedures and processes that include
information collection activities such as establishing monitoring and
sampling plans, documenting data and training, and ensuring disclosure
that produce for human consumption meets these requirements. The
regulations also provide for certain exemptions and variances to
qualified respondents. We use the information to verify that the
standards established by the regulation are followed such that produce
entering the marketplace is reasonably assured to be safe.
    In addition to the referenced regulations, we have developed a
draft guidance entitled ``Compliance with and Recommendations for
Implementation of the Standards for the Growing, Harvesting, Packing,
and Holding of Produce for Human Consumption for Sprout Operations''
(``Sprouts draft guidance'') available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm.
Sprouts represent a special food safety concern because the conditions
under which they are produced (time, temperature, water activity, pH,
and available nutrients) are ideal for the growth of pathogens, if
present. The draft guidance, when finalized, will assist sprout
operations subject to the regulations in part 112 to comply with the
sprout-specific requirements in subpart M.
    Description of Respondents: Respondents to this information
collection include farms that grow, harvest, pack, or hold produce for
human consumption, meaning fruits and vegetables such as berries, tree
nuts, herbs, and sprouts. Respondents are from the private sector (for-
profit businesses).
    We estimate the burden of the information collection as follows:

                                Table 1--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
                                   Number of      records per    Total annual          per
  Activity in 21 CFR Part 112    recordkeepers  recordkeeper 1      records       recordkeeping     Total hours
                                                                                (in hours) 2
----------------------------------------------------------------------------------------------------------------
Exemptions under Sec.   112.7.           3,285               1           3,285  0.5 (30 minutes)           1,643
Training under Sec.   112.30..          24,420               1          24,420  7.25............         177,045
Testing requirements for                48,361           2.990         144,599  0.825 (~50               119,294
 agricultural water under Sec.                                                   minutes).
  Sec.   112.44 and 112.45.
Records related to                     160,605           2.242         360,076  2.160...........         777,765
 agricultural water.
Testing requirements for                   256         245.660          62,889  0.403 (~24                25,344
 sprouts under Sec.  Sec.                                                        minutes).
 112.144, 112.145, and 112.147.
Records related to sprouts....           1,023          62.061          63,488  0.174 (~11                11,047
                                                                                minutes).
Following Recommendations for            1,023               1           1,023  1...............           1,023
 Implementation of the
 Standards for the Growing,
 Harvesting, Packing, and
 Holding of Produce for Human
 Consumption for Sprout
 Operations.
Documentation supporting                 4,568               1           4,568  0.079...........             361
 compliance with Sec.   112.2.
                               ---------------------------------------------------------------------------------
    Total.....................         243,541  ..............         664,348  ................       1,113,522
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Numbers rounded to nearest 1/1000.

                            Table 2--Estimated Annual Third-Party Disclosure Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR Part 112             Number of      disclosures        Total      per disclosure    Total hours
                                    respondents   per respondent    disclosures     (in hours)
----------------------------------------------------------------------------------------------------------------
Disclosure under Sec.  Sec.               77,165           3.459         266,914           1.422         379,551
 112.2, 112.6, 112.31, 112.33,
 and 112.142....................
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating or maintenance costs associated with annual disclosure.

    Section 112.7 (21 CFR 112.7) requires farms eligible for the
qualified exemption in accordance with Sec.  112.5 (21 CFR 112.5) to
maintain the records necessary to demonstrate that the farm satisfies
the criteria for the qualified exemption, including a written record
reflecting that the owner, operator, or agent in charge of the farm has
performed an annual review and verification of the farm's continued
eligibility for the qualified exemption. We estimate that 3,285 farms
are eligible for the qualified exemption and that each farm will spend
an average of 0.5 hours per year to maintain one record. Therefore,
3,285 recordkeepers x 0.5 average hours per recordkeeping = 1,642.5
hours (rounded to 1,643) to meet the recordkeeping requirements of
Sec.  112.7.
    Section 112.30 (21 CFR 112.30) requires the maintenance of records
of required training of personnel, including the date of training,
topics covered, and persons trained. We estimate that 24,420 farms will
maintain one record of required training and spend an average of 7.25
hours per year on recordkeeping. Therefore, 24,420 recordkeepers x 7.25
average hours per recordkeeping = 177,045 hours to meet the
recordkeeping requirements of Sec.  112.30.
    Section 112.46 (21 CFR 112.46) requires testing agricultural water
subject to the requirements of Sec. Sec.  112.44 and 112.45 (21 CFR
112.44 and 112.45). We estimate that 48,361 farms that will conduct
these tests. Thus, it is estimated that about three (2.990) records for
each farm will spend an average of 0.825 hours per record on testing
water. Therefore, 48,361 farms x 2.990 records x 0.825 average hours
per recordkeeping = 119,294.175 hours (rounded to 119,294) to meet the
recordkeeping requirements of Sec. Sec.  112.44 and 112.45.
    For records related to agricultural water, FDA estimates that there
are 160,605 recordkeepers each maintaining just over 2 records (2.242),
with each recordkeeping taking just over 2 hours (2.160). Therefore,
160,605 recordkeepers x 2.242 records x 2.160 hours = 777,765.046 hours
(rounded to 777,765) for the recordkeeping burden related to
agricultural water.
    Sections 112.144, 112.145, and 112.147 (21 CFR 112.144, 112.145,
and 112. 147) require testing for sprouts. We estimate that 256
recordkeepers will conduct these tests. Thus, it is estimated that
about 245 (245.660) records for each recordkeeper will spend an average
of 0.403 hour per record on testing sprouts. Therefore, 256
recordkeepers x 245.660 records x 0.403 average hours per recordkeeping
= 25,344.251 hours (rounded to 25,344) to meet the recordkeeping
requirements of Sec. Sec.  112.144, 112.145, and 112.147.
    We estimate that there are 1,023 recordkeepers for other records
related to sprouts. Thus, it is estimated that about 62 (62.061)
records for each recordkeepers will spend an average of 0.174 hour per
record. Therefore, 1,023 recordkeepers x 62.061 records x 0.174 average
hour per recordkeeping = 11,046.982 (rounded to 11,047) hours for the
burden to maintain records related to sprouts.
    We estimate 1,023 recordkeepers will utilize the recommendations in
the Sprouts draft guidance, once finalized, to maintain additional
records related to sprouts. We estimate each recordkeeping will take
about an hour for a recordkeeping burden of 1,023 hours.
    Section 112.2 relates to documentation supporting compliance. We
estimate that there are 4,568 recordkeepers each maintaining a record
of compliance. We estimate that each recordkeeper will spend 0.079 hour
maintaining their record. Therefore, 4,568 recordkeepers x 0.079 hour =
360.872 (rounded to 361) hours for the burden to maintain documentation
supporting compliance.
    Sections 112.2, 112.6, 112.31, 112.33, and 112.142 (21 CFR 112.2,
112.6, 112.31, 112.33, and 112.142) require third-party disclosures. We
estimate that 77,165 respondents are making these disclosures. Thus, it
is estimated that each respondent has around three (3.459) disclosures
and will spend an average of 1.422 hours per disclosure. Therefore,
77,165 respondents x 3.459 disclosures x 1.422 average hours per
disclosure = 379,551.331 hours (rounded to 379,551) for the third-party
disclosure burden to meet the requirements of Sec. Sec.  112.2, 112.6,
112.31, 112.33, and 112.142.
    The burden estimate reflects adjustments resulting in an overall
decrease of 19,847 hours. We have removed one-time burden that has been
realized since establishing the regulations; however, we have added
burden we attribute to our estimate of recordkeepers following the
recommendations in the Sprouts draft guidance.

    Dated: February 25, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03507 Filed 2-27-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Notices]
[Pages 43835-43836]
[FR Doc No: 2020-15624]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-193-000]

Columbia Gulf Transmission, LLC; Notice of Request for Extension
of Time

    Take notice that on July 7, 2020, Columbia Gulf Transmission, LLC
(Columbia Gulf) requested that the Federal Energy Regulatory Commission
(Commission) grant an extension of time, until November 15, 2021, in
order to place the replacement facilities of the Mainline 100 and
Mainline 200 Replacement Project (Project) into service, in Menifee and
Montgomery Counties, Kentucky, as authorized as part of Columbia Gulf's
Project in the November 15, 2019 Order Granting Certificate and
Approving Abandonment \1\ (November 15 Order). The November 15 Order
required Columbia Gulf to complete construction and make the facilities
available for service within one year of the order date. Columbia Gulf
states that, due to increased population density in the area along
certain discrete sections of Mainline 100 and Mainline 200, Columbia
Gulf is required, pursuant to Part 192 of the U.S. Department of
Transportation (DOT) regulations,\2\ to remediate the pipelines to
allow continued operation at the current maximum allowable operating
pressures (MAOP). Columbia Gulf states that, as provided by 49 CFR
190.341 Special Permit, an operator of a pipeline may submit an
application for a special permit, and provided that certain conditions
are met, the DOT may waive compliance from the regulations for specific
natural gas transmission pipeline segments. If granted, the special
permit allows the operator to continue to operate each special permit
segment at its current MAOP without first performing remediation work.
---------------------------------------------------------------------------

    \1\ Columbia Gulf Transmission, LLC, 169 FERC ] 62,084 (2019).
    \2\ 49 CFR 192.611 (2020).
---------------------------------------------------------------------------

    Columbia Gulf states that, on October 15, 2019, Columbia Gulf
applied for a special permit under the circumstances that the class
location changed due to development usage of land near the pipeline.
Columbia Gulf anticipates that a determination from DOT on its special
permit application may not be received until after the November 15,
2020 in-service deadline stipulated in the November 15 Order. If the
Commissions grants Columbia Gulf's request for an extension of time,
Columbia would take one of the following actions based on whether it
receives a special permit from DOT. If Columbia Gulf received the
special permit, Columbia Gulf would submit a motion to vacate the
authorization granted in the November 15 Order. If Columbia Gulf
doesn't obtain the special permit, Columbia Gulf would notify the
Commission of its intent to begin construction of the Project and
submit a revision to its Implementation Plan reflecting an updated
construction schedule.
    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on Columbia Gulf's
request for an extension of time may do so. No reply comments or
answers will be considered. If you wish to obtain legal status by
becoming a party to the proceedings for this request, you should, on or
before the comment date stated below, file a motion to intervene in
accordance with the requirements of the Commission's Rules of Practice
and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the
Natural Gas Act (18 CFR 157.10).\3\
---------------------------------------------------------------------------

    \3\ Only motions to intervene from entities that were party to
the underlying proceeding will be accepted. Algonquin Gas
Transmission, LLC, 170 FERC ] 61,144, at P 39 (2020).
---------------------------------------------------------------------------

    As a matter of practice, the Commission itself generally acts on

requests for extensions of time to complete construction for Natural
Gas Act facilities when such requests are contested before order
issuance. For those extension requests that are contested,\4\ the
Commission will aim to issue an order acting on the request within 45
days.\5\ The Commission will address all arguments relating to whether
the applicant has demonstrated there is good cause to grant the
extension.\6\ The Commission will not consider arguments that re-
litigate the issuance of the certificate order, including whether the
Commission properly found the project to be in the public convenience
and necessity and whether the Commission's environmental analysis for
the certificate complied with the National Environmental Policy Act.\7\
At the time a pipeline requests an extension of time, orders on
certificates of public convenience and necessity are final and the
Commission will not re-litigate their issuance.\8\ The OEP Director, or
his or her designee, will act on all of those extension requests that
are uncontested.
---------------------------------------------------------------------------

    \4\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2019).
    \5\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
    \6\ Id. at P 40.
    \7\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with NEPA.
    \8\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
---------------------------------------------------------------------------

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on July 29, 2020.

    Dated: July 14, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-15624 Filed 7-17-20; 8:45 am]
BILLING CODE 6717-01-P