[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 25052-25053]
[FR Doc No: 2023-08652]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34891; File No. 812-15374]

Hamilton Lane Private Assets Fund, et al.

April 19, 2023.
AGENCY: Securities and Exchange Commission (``Commission'' or ``SEC'').

ACTION: Notice.

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    Notice of application for an order (``Order'') under sections 17(d)
and 57(i) of the Investment Company Act of 1940 (the ``Act'') and rule
17d-1 under the Act to permit certain joint transactions otherwise
prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1
under the Act.
    Summary of Application: Applicants request an order to amend a
previous order granted by the Commission that permits certain business
development companies (``BDCs'') and closed-end management investment
companies to co-invest in portfolio companies with each other and with
certain affiliated investment entities.
    Applicants: Hamilton Lane Private Assets Fund, Hamilton Lane
Advisors, L.L.C., 2020 Tactical Market Fund LP, Astro Master Fund III,
LP, Dragon HL, L.P., DPE Investments Holdings LP, Edgewood Partners LP,
Edgewood Partners II LP, Edgewood Partners III LP, Fifth Stockholm CI
SPV L.P., Finance Street AIV Splitter L.P., Florida Growth Fund II LLC,
Green Core Fund, L.P.,

Hamilton Lane Capital Tower Fund LP, Hamilton Lane Co-Investment Fund
IV Holdings LP, Hamilton Lane Co-Investment Fund IV Holdings-2 LP,
Hamilton Lane Equity Opportunities Fund V Holding LP, Hamilton Lane
Equity Opportunities Fund V Holding-2 LP, Hamilton Lane Infrastructure
Fund Holdings LP, Hamilton Lane Infrastructure Fund Holdings-2 LP,
Hamilton Lane NM Fund I LP, Hamilton Lane Private Equity Fund X
Holdings LP, Hamilton Lane Private Markets Opportunity Fund LP, Credit
Series, Hamilton Lane Private Markets Opportunity Fund LP, Fund-Of-
Funds Series, Hamilton Lane Private Markets Opportunity Fund LP, Fund-
Of-Funds Series II, Hamilton Lane--Raytheon Technologies Pension
Emerging Managers, L.P., Hamilton Lane Secondary Fund V International
Series Fund LP, Series 2, Hamilton Lane SMID II Holdings LP, Hamilton
Lane Strategic Opportunities Fund V (Series 2019) Holdings LP, Hamilton
Lane Strategic Opportunities Fund VI (Series 2020) Holdings LP,
Hamilton Lane Strategic Opportunities Fund VII Holdings LP, Hamilton
Lane Strategic Opportunities Fund VIII Holdings LP, Hamilton Lane
Venture Access Fund I Holdings LP, Hamilton Lane Venture Capital Fund
LP, Series 2020, Hamilton Lane Venture Capital Fund LP, Series 2021,
Hamilton Lane Venture Capital Fund LP, Series 2022, Hamilton Lane-
Carpenters Partnership Fund V L.P., HL International Investors LP,
Series H2, HL-HP Global Investments LP, HLSF IV Holdings LP, HLSF V
Holdings LP, HLSF VI Holdings LP, HLSF VI Holdings 2 LP, Nakhoda Lane
Fund L.P., Nakhoda Lane Fund DE SPV LP, SRCS HL PE 1 (Master) LP,
Hamilton Lane/NYSCRF Israel Investment Fund L.P., Hamilton Lane/NYSCRF
Israel Investment Fund II L.P., HL Advanced Sustainable Total Return
Opportunities Fund III, HL ENPAM Fund Splitter LP, HL Environmental
Fund LP, HL Impact Holdings LP, HL Impact II Holdings LP, HL
International Investors L.P. Series M, HL International Investors L.P.
Series N, HL International Investors L.P. Series O, HL International
Investors L.P. Series Q, HL International Investors LP Series I, HL
International Investors LP, HL Secondary Opportunities 2018 Series, HL
International Investors LP, Series H1, HL International Investors, L.P.
Series P, HL Large Buyout Club Fund V, HL Large Buyout Club Fund VI, HL
MIRAS Secondary Fund LP, HL P Plus ESG Co-Invest Fund I LP, HL
Pennsylvania Co-Investment Fund, L.P., HL Private Assets Holdings LP,
HL Real Estate Asset Opportunities--A Master Fund LP, HL Venture
Capital Club Fund, HL/AS Global Coinvest LP, Hudson River Co-Investment
Fund III L.P., Innovation Lane LP, JATI Private Equity Fund III L.P.,
KPI-Hamilton Lane Multi-Strategy Fund I Master LP, KPS-Hamilton Lane
Multi-Strategy Fund I Master LP, KTCU HL Infrastructure Master Fund LP,
Libra Taurus PE Fund Master LP, Moran Real Asset Fund II, L.P., Moran
Real Asset Fund III, L.P., New York Credit Co-Investment Fund II LP,
New York Credit SBIC Fund L.P., PENHA Fund I L.P., PENHA Fund II L.P.,
Phoenix HL L.P., RAPM NM Secondary Opportunity Fund, L.P., RIHL Direct
Credit Fund LP, Russell Investments HL Private Markets Co-Investment
Master Fund LP, Russell Investments HL Private Markets Secondary Master
Fund LP, Sixth Stockholm CI-SPV LP, Smart Clean Air and Energy Fund LP,
SRE HL PE 1 (Master) LP, SREH HL PE 1 (Master) LP, SRZ HL PE 1 (Master)
LP, Tarragon Master Fund LP, Tower Bridge Select Opportunities--A
Master Fund LP, TTCPFS HL Investments Splitter AIV Fund LP, Utah Real
Assets Portfolio, LP, WPP HL Credit Opportunities Fund LP.
    Filing Dates: The application was filed on July 26, 2022, and
amended on January 25, 2023.
    Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing on any application by emailing
the SEC's Secretary at [email protected] and serving the
Applicants with a copy of the request by email, if an email address is
listed for the relevant Applicant below, or personally or by mail, if a
physical address is listed for the relevant Applicant below. Hearing
requests should be received by the Commission by 5:30 p.m. on May 15,
2023, and should be accompanied by proof of service on applicants, in
the form of an affidavit or, for lawyers, a certificate of service.
Pursuant to rule 0-5 under the Act, hearing requests should state the
nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by emailing the Commission's Secretary at
[email protected].

ADDRESSES: The Commission: [email protected]. Applicants:
Joshua B. Derringer, Esq., Faegre, Drinker, Biddle & Reath LLP, at
[email protected].

FOR FURTHER INFORMATION CONTACT: Jean E. Minarick, Senior Counsel, or
Kyle R. Ahlgren, Branch Chief, at<PHONE_NUMBER> (Division of
Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: For Applicants' representations, legal
analysis, and conditions, please refer to Applicants' first amended and
restated application, dated January 25, 2023, which may be obtained via
the Commission's website by searching for the file number at the top of
this document, or for an Applicant using the Company name search field,
on the SEC's EDGAR system. The SEC's EDGAR system may be searched at
https://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You
may also call the SEC's Public Reference Room at<PHONE_NUMBER>.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-08652 Filed 4-24-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Rules and Regulations]
[Pages 81798-81799]
[FR Doc No: 2020-27797]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 385

[Docket No. RM19-18-000; Order No. 862]

Formal Requirements for Filings in Proceedings Before the
Commission

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Final rule; announcement of effective date.

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SUMMARY: The Federal Energy Regulatory Commission is announcing the
effective date for changes to the Commission's regulations that provide
the address for hand-delivered filings and submissions to the
Commission.

DATES: The final rule published at 84 FR 46440 on September 4, 2019,
and delayed at 84 FR 55498 on October 17, 2019, is effective December
17, 2020.

FOR FURTHER INFORMATION CONTACT: Christopher Cook, Office of the
Secretary, 888 First Street NE, Washington, DC 20426,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Mark Hershfield, Office of the General Counsel, 888 First Street
NE, Washington, DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On August 27, 2019, the Commission issued a
final rule in Docket No. RM19-18-000 requiring that deliveries of
filings and submissions, other than by the United States Postal
Service, be sent to an off-site facility \1\ for security screening and
processing.\2\ The final rule, which was published in the Federal
Register on September 4, 2019, provided that the new regulation would
take effect 60 days after the date of publication of the final rule in
the Federal Register.\3\ On October 11, 2019, the Secretary issued a
document, stating that the effective date for the final rule was
postponed indefinitely to ensure that the public and the Commission
make an effective transition to utilizing the off-site facility.\4\ A
Notice of Effective Date was issued on June 23, 2020 annoucing the
regulation would take effect on July 1, 2020.\5\ This document serves
to make

the regulatory change effective in the CFR.
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    \1\ Federal Energy Regulatory Commission, c/o Health and Human
Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
    \2\ Formal Requirements for Filings in Proceedings Before the
Commission, 168 FERC ] 61,120 (2019) (Final Rule).
    \3\ 84 FR 46440.
    \4\ 84 FR 55498.
    \5\ 85 FR 38884.

    Issued: December 14, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-27797 Filed 12-16-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Notices]
[Page 39767]
[FR Doc No: 2015-16884]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission's staff may attend the following
meetings related to the transmission planning activities of the PJM
Interconnection, L.L.C. (PJM):

PJM Planning Committee

July 9, 2015, 9:30 a.m.-12:00 p.m. (EST)

PJM Transmission Expansion Advisory Committee

July 9, 2015, 11:00 a.m.-3:00 p.m. (EST)
    The above-referenced meetings will be held at: PJM Conference and
Training Center, PJM Interconnection, 2750 Monroe Boulevard, Audubon,
PA 19403.
    The above-referenced meetings are open to stakeholders.
    Further information may be found at www.pjm.com.
    The discussions at the meetings described above may address matters
at issue in the following proceedings:

Docket Nos. ER15-738 and ER15-739, PJM Interconnection, L.L.C.
Docket No. ER15-596, PJM Interconnection, L.L.C.
Docket Nos. ER15-33, et. al., The Dayton Power and Light Company.
Docket No. ER15-994, PJM Interconnection, L.L.C.
Docket No. ER15-639, PJM Interconnection, L.L.C.
Docket No. ER15-61, PJM Interconnection, L.L.C. and American
Transmission Systems Incorporated.
Docket No. ER14-2867, Baltimore Gas & Electric Company, et al., and PJM
Interconnection, L.L.C.
Docket Nos. ER14-972 and ER14-1485, PJM Interconnection, L.L.C.
Docket No. ER14-1485, PJM Interconnection, L.L.C.
Docket No. ER14-2864, PJM Interconnection, L.L.C.
Docket No. ER13-90, Public Service Electric and Gas Company and PJM
Interconnection, L.L.C.
Docket No. ER13-198, PJM Interconnection, L.L.C.
Docket Nos. ER13-1957, et al., ISO New England, Inc. et. al.
Docket No. ER13-195, Indicated PJM Transmission Owners.
Docket Nos. ER13-1944, et al., PJM Interconnection, L.L.C.
Docket No. ER15-1344, PJM Interconnection, L.L.C.
Docket No. ER15-1387, PJM Transmission Owners.
Docket No. EL15-40, Public Service Electric and Gas Company v. PJM
Interconnection, L.L.C.
Docket No. EL15-18, Consolidated Edison Company of New York, Inc. v.
PJM Interconnection, L.L.C.
Docket No. EL15-41, Essential Power Rock Springs, LLC et. al. v. PJM
Interconnection, L.L.C.
Docket No. ER13-1927, et al., PJM Interconnection- SERTP.

    For more information, contact the following:

Jonathan Fernandez, Office of Energy Market Regulation, Federal Energy
Regulatory Commission,<PHONE_NUMBER><EMAIL_ADDRESS>Alina Halay, Office of Energy Market Regulation, Federal Energy
Regulatory Commission,<PHONE_NUMBER><EMAIL_ADDRESS>
    Dated: July 1, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-16884 Filed 7-9-15; 8:45 am]
 BILLING CODE 6717-01-P


Reader's Guide to the Malathion E Docket # OPP 2004 0348 10/ 07/ 05 EPA has created this document to provide an organizational structure to the Malathion e docket. The docket index lists items sequentially, while this document lists them by subject matter. The Agency is providing the " Reader's Guide" to allow the reader to more easily access and navigate the various items contained in the Malathion e docket.

Risk Assessment Documents Docket Item No. Subject 4 Revised Human Health Risk Assessment 5 Dietary risk assessment support document 6 Residential risk assessment support document ( Table 2 corrected 10/ 07/ 2005) 10  14 Occupational risk assessment support document ( Table 2 of Docket item # 10 corrected 10/ 07/ 2005) 15 Benchmark Dose Analysis supporting document 16 Comparative Toxicity and Adjustment Factor supporting document 17 Human ( poisoning) incidents document 18  20 Drinking water exposure documents 21  25 Ecological Fate and Effects Chapter 2000 and supporting documents 27 EPA Document on Pesticide and Pharmaceutical Co exposure 34 EPA Response to Dr. Dementi's Dissenting Opinion U. S Department of Agriculture Documents 8 Operational procedures of the Boll Weevil Eradication Program 29 Status of Boll Weevil Eradication Program U. S. Food and Drug Administration Documents Docket Item No. Subject 26 FDA review of Ovide Lotion 28 FDA memorandum to EPA on co exposure Dissenting Opinion Documents of Dr. Brian Dementi Docket items 30  33 are documents submitted by Dr. Brian Dementi in support of his dissenting opinion on elements of the malathion risk assessment. The human health risk assessment document submitted in connection with Dr. Dementi's comments is a draft document, and differs from the final Revised Malathion Risk Assessment which is listed as item number 4. EPA's official response to Dr. Dementi's comments are contained in Item number 34.

Docket Item No. Subject 30  33 Dissenting Opinion of Dr. Dementi * Place holders for document numbers 7, and 9, have intentionally been left blank.


[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Notices]
[Pages 91987-91988]
[FR Doc No: 2016-30375]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:

    Rule 17a-13, SEC File No. 270-27, OMB Control No. 3235-0035.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and
Exchange Commission (``Commission'') is soliciting comments on the
collection of information provided for in Rule 17a-13 (17 CFR 240.17a-
13) under the Securities Exchange Act of 1934 (15 U.S.C. 78 et seq.)
(``Exchange Act''). The Commission plans to submit this existing
collection of information to the Office of Management and Budget
(``OMB'') for extension and approval.
    Rule 17a-13(b) (17 CFR 240.17a-13(b)) generally requires that at
least once each calendar quarter, all registered brokers-dealers
physically examine and count all securities held and account for all
other securities not in their possession, but subject to the broker-
dealer's control or direction. Any discrepancies between the broker-
dealer's securities count and the firm's records must be noted and,
within seven days, the unaccounted for difference must be recorded in
the firm's records. Rule 17a-13(c) (17 CFR 240.17a-13(c)) provides that
under specified conditions, the count, examination, and verification of
the broker-dealer's entire list of securities may be conducted on a
cyclical basis rather than on a certain date. Although Rule 17a-13 does
not require broker-dealers to file a report with the Commission,
discrepancies between a broker-dealer's records and the securities
counts may be required to be reported, for example, as a loss on Form
X-17a-5 (17 CFR 248.617), which must be filed with the Commission under
Exchange Act Rule 17a-5 (17 CFR 240.17a-5). Rule 17a-13 exempts broker-
dealers that limit their business to the sale and redemption of
securities of registered investment companies and interests or
participation in an insurance company separate account and those who
solicit accounts for federally insured savings and loan associations,
provided that such persons promptly transmit all funds and securities
and hold no customer funds and securities. Rule 17a-13 also does not
apply to certain broker-dealers required to register only because they
effect transactions in securities futures products.
    The information obtained from Rule 17a-13 is used as an inventory
control device to monitor a broker-dealer's ability to account for all
securities held in transfer, in transit, pledged, loaned, borrowed,
deposited, or otherwise subject to the firm's control or direction.
Discrepancies between the securities counts and the broker-dealer's
records alert the Commission and applicable self-regulatory
organizations (``SROs'') to those firms experiencing back-office
operational issues.
    Currently, there are approximately 4,067 broker-dealers registered
with the Commission. However, given the variability in their
businesses, it is difficult to quantify how many hours per year each
broker-dealer spends complying with Rule 17a-13. As noted, Rule 17a-13
requires a respondent to account for all securities in its possession
or subject to its control or direction. Many respondents hold few, if
any, securities; while others hold large quantities. Therefore, the
time burden of complying with Rule 17a-13 will depend on respondent-
specific factors, including a broker-dealer's size, number of
customers, and proprietary trading activity. The staff estimates that
the average time spent per respondent is 100 hours per year on an
ongoing basis to maintain the records required under Rule 17a-13. This
estimate takes into account the fact that more than half of the 4,067
respondents--according to financial reports filed with the Commission--
may spend little or no time complying with the rule, given that they do
not do a public securities business or do not hold inventories of
securities. For these reasons, the staff estimates that the total
compliance burden per year is 406,700 hours (4,067 respondents x 100
hours/respondent).
    The records required to be made by Rule 17a-13 are available only
to Commission examination staff, state securities authorities, and
applicable SROs. Subject to the provisions of the Freedom of
Information Act, 5 U.S.C. 522, and the Commission's rules thereunder
(17 CFR 200.80(b)(4)(iii)), the Commission does not generally publish
or make available information contained in any reports, summaries,
analyses, letters, or memoranda arising out of, in anticipation of, or
in connection with an examination or inspection of the books and
records of any person or any other investigation.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information has
practical utility; (b) the accuracy of the Commission's estimates of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Pamela Dyson, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: December 6, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-30375 Filed 12-16-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 137 (Wednesday, July 21, 2021)]
[Notices]
[Pages 38509-38510]
[FR Doc No: 2021-15427]

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SECURITIES AND EXCHANGE COMMISSION

[OMB Control No. 3235-0422, SEC File No. 270-373]

Proposed Collection; Comment Request

Extension:
    Rule 23c-3 and Form N-23c-3

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget (``OMB'') for extension and approval.
    Rule 23c-3 (17 CFR 270.23c-3) under the Investment Company Act of
1940 (15 U.S.C. 80a-1 et seq.) permits a registered closed-end
investment company (``closed-end fund'' or ``fund'') that meets certain
requirements to repurchase common stock of which it is the issuer from
shareholders at periodic intervals, pursuant to repurchase offers made
to all holders of the stock. The rule enables these funds to offer
their shareholders a limited ability to resell their shares in a manner
that previously was available only to open-end investment company
shareholders.
    There have been recent regulatory developments put forth by the
Commission that will provide shareholders of closed-end funds with
additional benefits. Effective August 1, 2021, rule 23c-3 will be
amended by including a new subparagraph (e) that will permit a fund
that relies on rule 23c-3 to register an indefinite amount of
securities, under Section 24 of the Investment Company Act upon the
effectiveness of a fund's registration statement.\1\ In addition,
concurrent with the implementation of rule 23c-3(e), the Commission
adopted an amendment to rule 24f-2 under the Investment Company Act,
permitting closed-end funds to compute registration fees on an annual
net basis.\2\ The Commission's intent in proposing and adopting rules
23c-3(e) and 24f-2(a) respectively, was to avoid the possibility a
closed-end fund of inadvertently selling more shares than it had
registered.\3\ These revisions to rule 23c-3 do not impose additional
collections of information.
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    \1\ 17 CFR 270.23c-3(e).
    \2\ 17 CFR 270.24f-2(a).
    \3\ Securities Offering Reform for Closed-End Investment
Companies (SEC Rel. No. IC-33427) (Mar. 20, 2019) [84 FR 14448 (Apr.
10, 2019)] at 64.
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    Notwithstanding these recent regulatory developments, a closed-end
fund that relies on rule 23c-3 must send shareholders a notification
that contains specified information each time the fund makes a
repurchase offer (on a quarterly, semi-annual, or annual basis, or, for
certain funds, on a discretionary basis not more often than every two
years). The fund also must file copies of the shareholder notification
with the Commission (electronically through the Commission's Electronic
Data Gathering, Analysis, and Retrieval System (``EDGAR'')) on Form N-
23c-3, a filing that provides certain information about the fund and
the type of offer the fund is making.\4\ The fund must describe in its
annual report to shareholders the fund's policy concerning repurchase
offers and the results of any repurchase offers made during the
reporting period. The fund's board of directors must adopt written
procedures designed to ensure that the fund's investment portfolio is
sufficiently liquid to meet its repurchase obligations and other
obligations under the rule. The board periodically must review the
composition of the fund's portfolio and change the liquidity procedures
as necessary. The fund also must file copies of advertisements and
other sales literature with the Commission as if it were an open-end
investment company subject to Section 24 of the Investment Company Act
(15 U.S.C. 80a-24) and the rules that implement Section 24. Rule 24b-3
under the Investment Company Act (17 CFR 270.24b-3), however, exempts
the fund from that requirement if the materials are filed instead with
the

Financial Industry Regulatory Authority (``FINRA'').
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    \4\ Form N-23c-3, entitled ``Notification of Repurchase Offer
Pursuant to Rule 23c-3,'' requires the fund to state its
registration number, its full name and address, the date of the
accompanying shareholder notification, and the type of offer being
made (periodic, discretionary, or both).
---------------------------------------------------------------------------

    The requirement that the fund send a notification to shareholders
of each offer is intended to ensure that a fund provides material
information to shareholders about the terms of each offer. The
requirement that copies be sent to the Commission is intended to enable
the Commission to monitor the fund's compliance with the notification
requirement. The requirement that the shareholder notification be
attached to Form N-23c-3 is intended to ensure that the fund provides
basic information necessary for the Commission to process the
notification and to monitor the fund's use of repurchase offers. The
requirement that the fund describe its current policy on repurchase
offers and the results of recent offers in the annual shareholder
report is intended to provide shareholders current information about
the fund's repurchase policies and its recent experience. The
requirement that the board approve and review written procedures
designed to maintain portfolio liquidity is intended to ensure that the
fund has enough cash or liquid securities to meet its repurchase
obligations, and that written procedures are available for review by
shareholders and examination by the Commission. The requirement that
the fund file advertisements and sales literature as if it were an
open-end fund is intended to facilitate the review of these materials
by the Commission or FINRA to prevent incomplete, inaccurate, or
misleading disclosure about the special characteristics of a closed-end
fund that makes periodic repurchase offers.
    The Commission staff estimates that 60 funds make use of rule 23c-3
annually, including 32 funds that are relying upon rule 23c-3 for the
first time. The Commission staff estimates that on average a fund
spends 89 hours annually in complying with the requirements of the Rule
and Form N-23c-3, with funds relying upon rule 23c-3 for the first time
incurring an additional one-time burden of 28 hours. The Commission
therefore estimates the total annual hour burden of the rule's and
form's paperwork requirements to be 6,236 hours. In addition to the
burden hours, the Commission staff estimates that the average yearly
cost to each fund that relies on rule 23c-3 to print and mail
repurchase offers to shareholders is about $32,744.13. The Commission
estimates total annual cost is therefore about $1,964,647.
    Estimates of average burden hours and costs are made solely for
purposes of the Paperwork Reduction Act and are not derived from a
comprehensive or even representative survey or study of the costs of
Commission rules and forms. Compliance with the collection of
information requirements of the rule and form is mandatory only for
those funds that rely on the rule in order to repurchase shares of the
fund. The information provided to the Commission on Form N-23c-3 will
not be kept confidential. An agency may not conduct or sponsor, and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.
    Written comments are invited on: (a) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burden of
the collection of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Cynthia
Roscoe, 100 F Street NE, Washington, DC 20549; or send an email to:
<EMAIL_ADDRESS>    All submissions should refer to File Number 270-373. This file
number should be included on the subject line if email is used. The
Commission will post all comments on the Commission's internet website
(http://www.sec.gov). All comments received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

    Dated: July 15, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-15427 Filed 7-20-21; 8:45 am]
BILLING CODE 8011-01-P


  MacroButton macIb01 i

EPA REGISTRATION DIVISION - COMPANY NOTICE OF FILING OF PESTICIDE
PETITION

EPA Registration Division contact: Sidney Jackson<PHONE_NUMBER>

Interregional Research Project Number 4

Pesticide Petition Number: 3E8203

	EPA has received a pesticide petition (3E8203) from Interregional
Research Project Number 4 (IR-4) Headquarters, IR-4, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W, Princeton,
NJ 08540 requesting, pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part
180 by establishing or revising the tolerances for residues of the
insecticide spinetoram, including its metabolites and degradates.
Compliance with the tolerance levels is to be determined by measuring
XDE-175-J: 1-H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione,
2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-[[(2R,5
S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,
3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro
14-methyl-,(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR); XDE-175-L:
1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione,
2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-[[(2R,5
S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,
3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-,
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS);
ND-J:(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-[[(2S,5S
,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-7,15-dioxo-2,
3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-indac
eno[3,2-d]oxacyclododecin-2-yl
6-deoxy-3-O-ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and NF-J:
(2R,3S,6S)-6-([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-eth
yl-2,4-di-O-methyl-alpha-L-mannopyranosyl)
oxy]-9-ethyl-14-methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,
15,16a,16b-octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-13-yl]oxy)
-2-methyltetrahydro-2H-pyran-3-yl(methyl)formamide in or on the raw
agricultural commodity coffee, green bean at 0.2 parts per million
(ppm), coffee, instant at 0.4 ppm, coffee, roasted bean at 0.4 ppm,
cottonseed subgroup 20C at 0.04 ppm, caneberry subgroup 13.07A at 0.7
ppm, bushberry subgroup 13-07B, except lingonberry at 0.25 ppm, fruit,
small, vine climbing, except fuzzy kiwifruit subgroup 13-07F at 0.5 ppm,
berry, low growing, subgroup 13-07G, except blueberry, lowbush, and
cranberry at 1.0 ppm, fruit, pome group 11-10 at 0.2 ppm, vegetable,
fruiting, group 8-10 at 0.4 ppm, fruit, citrus, group 10-10 at 0.3 ppm,
fruit, stone, group 12-12 at 0.2 ppm, onion, bulb, subgroup 3-07A at 0.1
ppm, onion, green, subgroup 3-07B at 2.0 ppm, nuts, tree, group 14-12 at
0.1 ppm.  EPA has determined that the petition contains data or
information regarding the elements set forth in section 408 (d)(2) of
FDDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
petition. Additional data may be needed before EPA rules on the
petition.

	It is also noted that the Agency has concluded that spinetoram should
be considered toxicologically identical to another pesticide, spinosad.
This conclusion is based on the following: (1) Spinetoram and spinosad
are large molecules with nearly identical structures; and (2) the
toxicological profiles for each are similar (generalized systemic
toxicity) with similar doses and endpoints chosen for human-health risk
assessment. Spinosad and spinetoram should be considered toxicologically
identical in the same manner that metabolites are generally considered
toxicologically identical to the parent.

A. Residue Chemistry

	1. Plant metabolism. The nature of the residue in plants (turnip, apple
and lettuce) has been determined using radiolabeled spinetoram and is
adequately understood, per the EPA document entitled, ``Spinetoram:
Residue Chemistry Summary Concerning the Application of Spinetoram to
Numerous Crop'' dated August 9, 2007 (DP#325387).  Three metabolic
pathways are believed responsible for the breakdown of spinetoram in
plants.  The first involves changes to the N-demethyl moiety on the
forosamine sugar to give the N-demethyl and N-formyl metabolites; it is
believed photolysis plays a key role in this pathway.  The second
pathway involves cleavage of the macrolide ring system at one or more
positions and results in a complex residue mixture of numerous
components.  The third involves changes to the XDE-175-J only and
produces 3-O-deethyl and C9-pseudoaglycone (in apples) or the
C17-pseudoaglycone (in turnip tops). It is presumed the XDE-175-L
underwent degradation by the third pathway also, but too quickly to
allow detection of any metabolites.  Based on the plant metabolism
studies and the product ratio of 3:1 for XDE-175-J and XDE-175-L, HED
has established the residue of concern in plants for the purposes of
tolerances enforcement and risk as spinetoram (XDE-175-J and XDE-175-L)
plus the two metabolites: N-demethyl-XDE-175-J (also known as ND-J) and
N-formyl-XDE-175-J (also called NF-J).

	2. Analytical method. Per the Federal Register of October 10, 2007 (
HYPERLINK "http://www.epa.gov/EPA-PEST/2007/October/Day-10/p19947.htm"
72 FR 57492 ) (FRL-8149-9) supported by DP # 325387, August 9, 2008, EPA
has determined adequate analytical methods are available for enforcement
purposes for spinetoram in plant and animal matrices.  For more details
on the analytical methods and for specific GRMs, see the 2011 spinosad
and spinetoram scoping document (EPA, DP# 446932, August 9, 2011).  EPA
conservatively concluded that for water, residues should be estimated
using the total spinetoram residue method (EPA, DP# 331741, September
20, 2007).

	3. Magnitude of residues. IR-4 supports translation of the proposed
tolerances for spinosad in coffee, green bean, coffee, instant, and
coffee, roasted bean to spinetoram. Per the Federal Register of April
15, 1998 (63 FR 18329)(FRL-5785-7), EPA previously concluded that the
translation of spinosad residue data to spinetoram for crops was
acceptable due to the similar chemical structures, similar residue
levels for similar application rates, and the similar or lower
application rates of spinetoram relative to spinosad.  Translation of
spinosad processing factors to spinetoram has also been deemed
acceptable (EPA, DP# 325387, April 28, 2009).  Based on this, and the
similar proposed use patterns of spinosad and spinetoram in coffee (with
maximal use rates being lower for spinetoram than for spinosad), the
IR-4 spinosad MOR trials in coffee—summarized in a separate Notice of
Filing—support spinetoram tolerances of 0.2 ppm for coffee, green bean
and 0.4 ppm for coffee, instant and coffee, roasted bean.

IR-4 requests revisions to the following crop groups/subgroups based
upon established tolerances: onion, bulb subgroup 3-07A; onion, green
subgroup 3-07B; fruiting vegetable group 8-10; citrus fruit group 10-10;
pome fruit group 11-10; stone fruit group 12-12; caneberry subgroup
13-07A; bushberry subgroup 13-07B, except lingonberry; small fruit vine,
climbing subgroup, except fuzzy kiwifruit 13-07F; low growing berry
subgroup 13-07G, except blueberry, lowbush, and cranberry; tree nut
group 14-12; and cottonseed subgroup 20C.

B. Toxicological Profile. The toxicity database for spinetoram relies on
studies for spinetoram as well as studies for a similar spinosyn
insecticide, spinosad.  EPA concluded that spinetoram is toxicologically
identical to the pesticide spinosad “in the same manner that
metabolites are generally considered toxicologically identical to the
parent”.  EPA picked the lowest of the spinosad and spinetoram
endpoints for each exposure scenario.  A summary of the toxicological
endpoints for spinosad and spinetoram used for human risk assessment can
be found at   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov  in docket EPA-HQ-OPP-2007-0310.  Relevant
information is summarized in the subsections below.  Per ``Spinetoram:
Human Health Risk Assessment for Numerous Proposed Application
Scenarios'' dated September 20, 2007 (DP#331741), EPA determined the
toxicological profile and endpoints for spinetoram are adequate for risk
assessment evaluations and determination of FQPA.  Under the new 40 CFR
Part 158 data requirements for spinosad/spinetoram, there are no missing
studies at this time. There was no evidence of increased pre- and
post-natal susceptibility based on prenatal developmental toxicity
studies (rat and rabbit) and 2-generation reproductive toxicity studies
(rat) with either spinosad or spinetoram. In addition, there was no
evidence of neurotoxicity in the toxicity database that included acute
and subchronic neurotoxicity studies with spinosad and an acute
neurotoxicity study with spinetoram. An immunotoxicity study has been
conducted with Spinosad and EPA’s initial review indicate the level of
concern for immunotoxicity is low (EPA, DP# 446932, August 9, 2011).

	1. Acute toxicity.  No appropriate endpoint attributable to a single
dose was identified; the EPA has not established an acute reference dose
(RfD) for spinetoram.

	2. Genotoxicty. All mutagenicity studies conducted on spinetoram were
negative.

	3. Reproductive and developmental toxicity. EPA has concluded there is
no evidence of increased susceptibility of rat and rabbit fetuses to in
utero exposure to spinetoram.  In the developmental toxicity study in
rats, no developmental effects were observed at dose levels that induced
maternal toxicity.  In the developmental study in rabbits, no
developmental toxicity was seen at dose levels that induced maternal
toxicity.  In the 2-generation reproduction study, no offspring toxicity
occurred.  Parental/systemic toxicity was observed at a lower dose than
the dose at which offspring showed no effects.  EPA has determined that
“reliable data show that it would be safe for infants and children to
reduce the 10x FQPA safety factor to 1x.”

	4. Subchronic toxicity. Both Short-term endpoints (inhalation and
incidental oral) were established for spinetoram based on the Oral
no-observed adverse effect level (NOAEL) of 4.9 mg/kg/day from the
subchronic feeding study in dogs with spinosad and a Level of Concern
(LOC) for the Margin of Exposure (MOE) of 100.

	5. Chronic toxicity. EPA used the lowest NOAEL of 0.249 mg/kg/day from
the chronic toxicity study in dogs for spinetoram and a 100X UF to
establish a chronic reference dose (cRfD) of 0.0249 mg/kg/day.
Spinetoram is considered ``Not likely to be Carcinogenic to Humans''
based on its similarity to spinosad.

	6. Animal metabolism. From single and multiple dose ADME studies in
rats, it was estimated that the fraction of an orally administered dose
absorbed is 70% or greater for both isomers of spinetoram.  Fecal
excretion was the major route of elimination, while urine was a minor
route (10% or less of the absorbed dose).  At 168 hours post-dosing, the
radioactivity did not exceed 1% of the administered dose in any of the
analyzed tissues.  The majority of the radioactivity recovered for urine
and fecal extracts was present as parent plus several metabolites
including the glutathione and hydroxylated conjugates.  Livestock
metabolism studies conducted in the goat and hen were confirmatory that
excreta account for the majority of the recovered administered dose;
this especially true in the hen (91 to 93%).  In the hen, the highest
residues were observed in the fat followed by skin fat, liver, eggs and
muscle.

	7. Metabolite toxicology. Per the Federal Register of March 19, 2008
(Vol 73, No 54; FRL-8344-1), the results of the plant and animal
metabolism studies and toxicity testing have been assessed.  Metabolite
toxicity has been addressed by establishment of the total residue for
tolerance purposes as the parent materials XDE-175-J and XDE-175-L plus
the two metabolites: ND-J and NF-J.  Per the EPA Hunan Health Risk
Assessment for Spinetoram of Sept 20, 2007 (DP#331741), it was concluded
that the demethylated, deethylated and hydroxylated forms of the parent
are “highly unlikely” to be more toxic than the parent.

	8. Endocrine disruption. The EPA’s EDSP (Endocrine Disruptor
Screening Program) is still under development.  For now, the EPA has
concluded that “the NOAELs derived from the reproduction/fertility
study, are well defined and together with the 100X UF, will provide
adequate protection for potential endocrine effects.”

C. Aggregate Exposure

	1. Dietary exposure. i. Acute exposure. No quantitative acute dietary
exposure assessment has been required for spinosad.

ii. Chronic exposure.  Spinosad and spinetoram are deemed
toxicologically equivalent by EPA.  Based on the similarity of the
insecticides and the anticipated markets for each, it is unlikely that
spinosad and spinetoram will be applied to the same crop.  Hence, EPA
aggregated exposure by either assuming that all commodities contain
spinosad (because side-by-side spinosad and spinetoram residue data
indicated that spinetoram residues were less than or equal to spinosad
residues) or summing the percentage of a crop that would be treated with
spinosad and the percentage that would be treated with spinetoram.

	i. Food. The chronic dietary exposure assessment (EPA, DP#380915,
August 18, 2010) was recreated in Dietary Exposure Evaluation Model -
Food Consumption Intake Database (DEEM-FCID) (version 3.14) as a
starting point.  The new proposed tolerance values for coffee
commodities were included in this dietary assessment.  The EPA analysis
assumed 100% crop treated for many commodities, tolerance-level
residues, and default processing factors, but with several exceptions:
average field trial residues were applied for the cucurbit vegetables
(group 9), citrus (group 10), pome fruit (group 11), cereal grain (group
15), herbs (group 19a), spices except black pepper (group 19b), banana
and plantain, strawberry, and grape; average United States Department of
Agriculture (USDA) Pesticide Data Program (PDP) detected residues were
applied for cherry and peach, with the peach residues applied to fennel
as well; experimental processing factors were applied for corn meal,
corn oil, corn flour, corn starch, wheat flour, wheat germ, apple juice,
raisin, and orange juice, with the orange juice processing factor
applied to all citrus juice.  Ruminant and hog residues were estimated
based on reasonably balanced dietary burdens and extrapolation from a
dermal pour-on study (a cancelled use) to the registered premise
application for estimation of residues resulting from dermal absorption.
 Poultry residues were also estimated based on reasonably balanced
dietary burdens and the premise application.

	ii. Drinking water. Drinking water estimates were previously determined
based on EPA screening models and concentrations were directly entered
into the dietary exposure model. For spinosad, estimated environmental
concentrations (EECs) for chronic exposures are conservatively
calculated based on a total residue approach to be 10.5 ppb for surface
water using the First Index Reservoir Screening Tool (FIRST) and 1.1 ppb
for ground water using the Screening Concentration in Ground Water
(SCI-GROW) model (EPA, DP#331271, July 28, 2006).  Thus, for the joint
chronic dietary risk assessment, EPA has used the water concentration
value of 10.5 ppb to assess the contribution to drinking water.  This
value was supported by a 2010 drinking water assessment in support of a
seed treatment use for spinosad (EPA, DP#377550, November 15, 2010).

	2. Non-dietary exposure. EPA has determined there is potential for
residential handler and post-application exposures to
spinosad/spinetoram.  Because spinosad and spinetoram control similar
pests, EPA concluded these products will not be used in combination with
each other and combining the residential exposures is unnecessary.  The
most recent residential exposure assessment was performed in 2011 (EPA,
DP# 446932, August 9, 2011), however in 2012, new “Standard Operating
Procedures (SOPs) for Residential Pesticide Exposure Assessment” were
released by EPA.  Residential exposure assessments have been updated to
reflect the new SOPs.  Short-term residential inhalation risks were
estimated for adult residential handlers, as well as short-term
post-application incidental oral risks for toddlers, based on
applications to home lawns, home gardens and ornamentals.  Additionally,
short-term and intermediate-term post-application incidental oral risks
for toddlers were estimated based on a cat/kitten spot-on application.

D. Cumulative Effects

	EPA has not made a common mechanism of toxicity finding as to spinosad
and any other substances and spinosad does not appear to produce a toxic
metabolite produced by other substances.  EPA’s Health Effects
Division (HED), Hazard Assessment and Policy Committee noted that
toxicologically equivalent does not imply a cumulative assessment which
involves the concepts of mechanism of toxicity and potency.  For the
purposes of tolerance action, it is not assumed that spinosad has a
common mechanism of toxicity with other substances.

E. Safety Determination The proposed actions of this petition have been
added via DEEM to EPA’s most recent dietary assessment for
spinetoram/spinosad (EPA, DP#380915, August 18, 2010) and the
residential assessment has been updated to reflect current EPA
practices.  The additional exposure from the proposed coffee use is
estimated to be 0 to 0.02% of the cPAD.  Short-term, intermediate-term,
and chronic aggregate exposure estimates all resulted in MOEs that were
above the established LOC of 100.  Dow AgroSciences concludes with
reasonable certainty that no harm will result to the general population
or infants and children from the aggregate exposure to spinetoram
residues from these uses.

	1. U.S. population. The resulting dietary (food and drinking water)
exposure estimates are not of concern to EPA; exposure for the general
population is estimated as <11% of the cPAD.  When the dietary exposure
is summed with the estimated residential inhalation exposure, the
resulting short-term aggregate MOE value was approximately 1800.

	2. Infants and children. EPA has determined that reliable data allow a
reduction of the FQPA safety factor to 1X for infants and children.  The
resulting dietary exposure for the most exposed subpopulation (children
1 to 2 years) is estimated as <28% of the cPAD.  Short-term
post-application risks were estimated for toddlers, based on application
to home lawns, home gardens, ornamentals, and pets and risks were not of
concern given that resulting MOEs were >500.  The resulting short-term
aggregate MOE values were >300 and are, therefore, not of concern to
EPA.  Intermediate-term post-application risks were estimated for
toddlers, based on application to pets and risks were not of concern
given resulting MOEs were ≥700.  The resulting intermediate-term
aggregate MOE values were >200 and are, therefore, not of concern to
EPA.

F. International Tolerances

	International MRLs are in place for spinetoram on coffee beans in the
EU and Australia.  The USDA MRL database, the third party database
Homologa, the EU SANCO website, the Australian MRL website, and the
Japan MRL website were queried for MRLs germane to this petition.  These
MRLs are listed to the best of our knowledge; no claim is made regarding
the verification of these values relative to the national authorities.

Spinetoram

Commodity	Existing MRLa

(

1

—

›

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B*

਀the * and T notations are direct translations from the country
website listings.

 PAGE

 PAGE   6


[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Notices]
[Pages 30733-30736]
[FR Doc No: 2019-13751]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2012]

New Drugs Regulatory Program Modernization: Improving Approval
Package Documentation and Communication

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is seeking
public comment on the Clinical Data Summary Report Pilot program as
part of the Agency's continuous assessment of the efficiency and
transparency of the clinical data used in the regulatory decision-
making process. The Agency is also seeking public feedback on a new
integrated review template for the documentation of new drug marketing
applications developed as part of the New Drugs Regulatory Program
Modernization. The Agency hopes to receive public feedback on both of
these efforts and on how FDA might continue supporting our
stakeholders' needs related to the clarity and transparency of drug
approval decisions.

DATES: Submit either electronic or written comments on the notice by
August 26, 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 August 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 26, 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-2019-N-2012 for ``New Drugs Regulatory Program Modernization:
Improving Approval Package Documentation and Communication.'' 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:
    Regarding the Clinical Data Summary Pilot Program: Patrick Zhou,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, Rm. 1148, Silver Spring, MD 20993-
0002,<PHONE_NUMBER><EMAIL_ADDRESS>with the subject line
``Collecting Public Feedback on the Clinical Data Summary Pilot
Program.''
    Regarding the Integrated Review: Kevin Bugin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5128, Silver Spring, MD 20993-0002, 301-
796-2302<EMAIL_ADDRESS>with the subject line ``Collecting
Public Feedback on the Integrated Review.''

SUPPLEMENTARY INFORMATION:

I. Background

    Currently, FDA's Center for Drug Evaluation and Research (CDER)
provides access to action packages, which include all discipline
reviews, for newly approved original new drug applications (NDAs) and
biologics license applications (BLAs) by posting these action packages
on the FDA website at www.fda.gov/[email protected]. FDA posts them regardless
of whether there has been a request under the Freedom of Information
Act (FOIA), 5 U.S.C. 552.
    Other approval-related information such as review documents for
abbreviated new drug applications (ANDAs) or NDA efficacy supplements
are posted on www.fda.gov/[email protected] after they have been redacted and
disclosed in response to a FOIA request, but they are not routinely
posted proactively by the Agency. While the action packages include a
significant amount of information from the sponsor's application, they
can reach up to hundreds of pages and include administrative and/or
correspondence-related documentation. As a result, some stakeholders
have difficulty navigating the documents and using them to gain an
understanding of the basis for FDA drug approvals. To address this, two
efforts have been launched: (1) A pilot program referred to as the
Clinical Data Summary Pilot Program (Pilot), launched in January 2018,
through which parts of a sponsor's clinical study reports (CSRs) were
to be posted and (2) a new integrated template that will be used to
document FDA's review of new drug applications and efficacy
supplements. This document seeks public comment on both of these
efforts.
    On January 16, 2018, then-FDA Commissioner Scott Gottlieb announced
several efforts to enhance the transparency of the Agency's drug
approval decisions as part of an overall approach to enhance the
efficiency and transparency of the Agency's drug approval decisions.
One of those efforts included the Pilot program to evaluate whether
publicly disclosing certain summary information included within
sponsor-submitted CSRs improves public understanding of the basis of
FDA's approval decisions.
    The Pilot's goals included enhancing the understanding of
information about drug approvals to improve the accuracy of discussions
about drug approvals in scientific publications, increasing
stakeholders' understanding of the basis for FDA's approval decisions,
and informing physicians and other healthcare providers about the
clinical trial results on which regulatory decisions are based.
    For this Pilot, FDA sought voluntary participation from the
sponsors of fewer than ten marketing applications selected on the basis
of novelty and clinical importance (e.g., products that are novel
including drugs that are new molecular entities, products across a
range of disease areas, and products of scientific interest). For any
approved application whose sponsor agreed to participate, FDA would
post, along with the traditional action package, summary portions of
the sponsor's CSRs for the pivotal trials establishing the safety and
effectiveness of the drug. One sponsor voluntarily agreed to
participate. The subsequent posting can be found on FDA's Clinical Data
Summary Pilot Program web page at https://

www.fda.gov/drugs/developmentapprovalprocess/ucm589210.htm. All other
contacted sponsors declined to participate in the Pilot. The
recruitment phase of the Pilot is now concluded.
    FDA recognizes that the needs and expectations of different
stakeholders regarding transparency of information relating to drug
approval decisions may vary. By opening a public docket, FDA hopes to
learn from its stakeholders more about the potential benefits or risks,
resource requirements, and challenges of FDA publicly releasing a
limited number of sections from certain CSRs at the time of marketing
approval.
    In addition to the Pilot, FDA has other efforts that also seek to
provide greater clarity on FDA's application review and decision-making
process. One of those efforts is the new integrated review process and
template developed under the New Drugs Regulatory Program
Modernization, which is part of a multiyear, multiphase effort to
enhance the new drugs regulatory program. The new integrated review
process and template are intended to promote more integrated and
interdisciplinary assessments, enhance clarity of our assessments
regarding the benefits and risks for new drug products, and improve our
communication about the basis for new drug approvals. For more
information, please see CDER Director Janet Woodcock's notes of June 4,
2018, available at https://www.fda.gov/news-events/fda-voices-perspectives-fda-experts/fda-proposes-process-modernization-support-new-drug-development.

II. The Integrated Review Process

    The new integrated review process and documentation template,
currently being implemented, supports reviewers in conducting a
scientifically-rigorous review that efficiently documents regulatory
decisions. The integrated review process includes the use and public
posting, upon approval of a new drug or biologic, of an integrated
review document that contains a summary, an integrated assessment, and
appendices. This new review template would replace the current
documentation where each discipline provides a separate application
review document. The updated template would be a collaborative document
with input from clinical, clinical pharmacology, biostatistics,
toxicology reviewers, and other disciplines based upon the issues
raised by the application. FDA believes this program will also meet the
goal of effectively communicating the basis for new drug approvals. The
Agency is therefore considering whether to focus its efforts to better
communicate the basis for drug approvals on the development of new
integrated review documents, rather than on the release of CSRs.
    The guiding principles of this initiative are the importance of
conducting an issue-focused assessment, enhanced communication both
within the review team and with the applicant, and stronger
interdisciplinary collaboration. FDA believes that the format and
content of the integrated review will provide a clearer description of
FDA's analysis of the scientific issues raised by the application, and
will thereby more effectively communicate the basis for the approval
decision.
    As mentioned above, the integrated review template has three main
components:

 Summary:

    [cir] Contains an executive summary of FDA's decision and
assessment of the application, including FDA's benefit-risk
determination (as currently employed in marketing application reviews)
    [cir] Provides an overall Agency assessment, including an overview
of the major decisions made during the review process, and a brief
discussion of the basis for the decisions
 Integrated Assessment:
    [cir] Promotes succinct, integrated, focused analyses of the
evidence of benefit-risk, and therapeutic individualization (e.g.,
special populations, drug interactions)
    [cir] Highlights key issues in an interdisciplinary manner that the
review team thinks are pertinent to the decision-making process
 Appendices:
    [cir] Contains assessments and analyses that are supportive or
important to key facts/data or conclusions for the overall review
    [cir] Contains work that did not directly impact the overall
assessment of benefit-risk, regulatory action, labeling, or risk
mitigation plans

    The target audiences for this document are diverse, and include the
lay public with a specific interest in the particular application, drug
sponsors, researchers and others who are seeking to understand the
basis for FDA's decision. In general, the first two parts of the
integrated document would be expected to provide a complete explanation
of FDA's action, with the third component (the appendices) also
available for those looking for additional detail on the comprehensive
analyses FDA conducted in its review of the drug application.
    As part of FDA's internal assessment for both of these programs,
the Agency is interested in receiving responses to the following
questions, in addition to any general comments the public might have.
For convenience, it would be helpful if commenters refer to the
numbered question and subject when submitting responses and comments to
the following questions:

A. Regarding the Clinical Data Summary Pilot Program

    Please see the CSR posting available on FDA's Clinical Data Summary
Pilot Program web page at https://www.fda.gov/drugs/developmentapprovalprocess/ucm589210.htm.
    1. How did the CSR posted in this Pilot affect or compare with your
understanding of the CSRs submitted to FDA by drug sponsors?
    2. How usable and/or accessible was the information in the CSR that
was posted for the Pilot?
    3. Did the required redactions/removal of certain information from
the posted CSR affect your understanding or use of the posted
information?
    4. How might the information/content posted from this Pilot be
used? What other information/content would have been helpful?
    5. Given the other review documents available (e.g., FDA's action
package), how did the posted CSR affect your understanding of FDA's
decision-making process regarding drug applications?
    6. What do you believe would be the potential advantages and
disadvantages of posting this information routinely?
    7. Is there any additional information you would like to provide
regarding the potential benefits or risks, resource requirements, and
international challenges of publicly releasing a limited number of
sections from certain CSRs at the time of marketing approval?
    To illustrate the new integrated review template, the original
reviews for NDA 210806 (PIFELTRO (doravirine) tablets, 100 milligrams
(mg)) and NDA 210807 (DELSTRIGO (doravirine, lamivudine, and tenofovir
disoproxil fumarate) tablets, 100/300/300 milligrams) have been
rewritten to provide an example. The original multidisciplinary review
for the NDAs and the information provided in the new integrated review
template are posted on https://www.fda.gov/newdrugsmodernization#integrated.

B. Regarding the Integrated Review

    1. How does the new format of the integrated review inform your
knowledge of FDA's basis for making decisions?

    2. How does the usability and accessibility of information in the
new integrated review compare to the original review posted on FDA's
website?
    3. How could the information provided in the new integrated review
format be used, if at all?
    4. What do you believe would be the potential advantages and
disadvantages of posting review documents in this format?
    5. Based on the integrated review, were the issues that concerned
the review team clear and understandable? If so, what helped achieve
this? If not, what can be improved?
    6. Is there important information in the integrated review that is
difficult to locate or should be added?

    Dated: June 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13751 Filed 6-26-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 79 (Thursday, April 23, 2020)]
[Notices]
[Page 22730]
[FR Doc No: 2020-08631]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-136-000]

Guardian Pipeline L.L.C.; Notice of Request Under Blanket
Authorization

    Take notice that on April 8, 2020, Guardian Pipeline L.L.C.
(Guardian), 100 West Fifth Street, ONEOK Plaza, Tulsa, Oklahoma 74103,
filed in the above referenced docket, a prior notice request pursuant
to sections 157.205 and 157.211 of the Commission's regulations under
the Natural Gas Act and its blanket certificate issued in Docket No.
CP00-36-000 for authorization to construct and operate the Graymont
Western Lime Project in Fond du Lac County, Wisconsin. Guardian states
the proposed project will consist of a new delivery point connecting
Guardian to Graymont Western Lime, Inc., which will measure a gas
volume of 5 million cubic feet (MMcf) per day with a potential for
expansion up to 13.2 MMcf per day. Guardian estimates the cost of the
project to be approximately $822,000, all as more fully set forth in
the application which is on file with the Commission and open to public
inspection.
    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://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 the 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.
    Any questions regarding this prior notice request should be
directed to Denise Adams, Director of Regulatory Affairs, Guardian
Pipeline L.L.C., 100 West Fifth Street, ONEOK Plaza, Tulsa, Oklahoma
74103, by telephone at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention. Any person filing to intervene, or
the Commission's staff may, pursuant to section 157.205 of the
Commission's Regulations under the NGA (18 CFR 157.205) file a protest
to the request. If no protest is filed within the time allowed
therefore, the proposed activity shall be deemed to be authorized
effective the day after the time allowed for protest. If a protest is
filed and not withdrawn within 30 days after the time allowed for
filing a protest, the instant request shall be treated as an
application for authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    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 should
submit an original and 3 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.

    Dated: April 17, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-08631 Filed 4-22-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Page 41627]
[FR Doc No: 2020-14839]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0027]

Addendum to the Memorandum of Understanding With the Department
of Energy (August 28, 1992); Oak Ridge, Tennessee Properties

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: This is a notice of an addendum to the interagency Memorandum
of Understanding (MOU) between the U.S. Department of Labor (DOL),
Occupational Safety and Health Administration (OSHA) and the U.S.
Department of Energy (DOE). The MOU establishes specific interagency
procedures for the transfer of occupational safety and health coverage
for privatized facilities, properties, and operations from DOE to OSHA
and state agencies acting under state plans approved by OSHA.

DATES: The expansion of the scope of recognition becomes effective on
July 10, 2020.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Ms. Mikki Holmes, Acting
Director, OSHA Office of Federal Agency Programs, Directorate of
Enforcement Programs, U.S. Department of Labor, telephone: (202) 693-
2110; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    DOE and OSHA have entered into two MOUs to address both current and
former DOE government-owned or leased, contractor-operated (GOCO)
facilities. The first MOU, entered into on August 10, 1992, delineates
regulatory authority over the occupational safety and health of
contractor employees at DOE GOCO facilities by recognizing that DOE
exercises statutory authority under section 161(f) of the Atomic Energy
Act of 1954, as amended, (42 U.S.C. 2201(f)), relating to the
occupational safety and health of private-sector employees at these
facilities.
    Section 4(b)(1) of the Occupational Safety Health Act of 1970 (OSH
Act) (29 U.S.C. 653(b)(1)) exempts from OSHA authority working
conditions to which other federal agencies have exercised statutory
authority to prescribe or enforce standards or regulations affecting
occupational safety and health. The 1992 MOU acknowledges DOE's
extensive program for the regulation of contractor health and safety,
which requires contractor compliance with all OSHA standards along with
additional DOE-prescribed requirements. The MOU sets forth an agreement
that the provisions of the OSH Act do not apply to GOCO sites for which
DOE has exercised authority to regulate occupational safety and health
under the Atomic Energy Act.
    As a result of DOE's policy emphasis on privatization activities,
OSHA and DOE entered into a second MOU on July 25, 2000, to establish
interagency procedures addressing regulatory authority for occupational
safety and health at specified privatized facilities and operations on
sites formerly controlled by DOE. The July 25, 2000, MOU covers
facilities and operations on lands no longer controlled by DOE, which
are not conducting activities for, or on behalf of, DOE; and where
there is no likelihood that any employee exposure to radiation from DOE
sources would be 25 millirems per year (mrem/yr) or more.

II. Notice of Transfer

    In an email dated May 1, 2020, DOE requested that OSHA or, as
appropriate, the Tennessee Occupational Safety and Health
Administration (TOSHA) accept occupational safety and health regulatory
authority over employees at the East Tennessee Technology Park in Oak
Ridge, Tennessee, one parcel of land pursuant to the MOU on Safety and
Health Enforcement at Privatized Facilities and Operations dated July
25, 2000. Other facilities and properties at the East Tennessee
Technology Park were transferred to TOSHA jurisdiction under this MOU
by Federal Register notices 74 FR 120 (January 2, 2009); 74 FR 39977
(August 10, 2009); 76 FR 80408 (December 23, 2011); and 79 FR 29456
(May 22, 2014).
    The parcel of land, located at the East Tennessee Technology Park
in Oak Ridge, Tennessee, and transferred by deed to the Community Reuse
Organization of East Tennessee (CROET), is the Land Parcel Powerhouse
Area, Duct Island, K-1007-P1 Pond Area at the East Tennessee Technology
Park (ETTP).
    OSHA's Regional Office in Atlanta, Georgia, working with the OSHA
Nashville Area Office and TOSHA, determined that TOSHA is willing to
accept authority over the occupational safety and health of public-
sector and private-sector employees at the parcel of land at the East
Tennessee Technology Park in Oak Ridge, Tennessee, that was transferred
by deed to CROET. In a letter from OSHA to DOE dated June 26, 2020,
OSHA stated that TOSHA is satisfied with DOE's assurances that (1)
there is no likelihood that any employee at facilities in the vicinity
of the land parcel will be exposed to radiation levels that will be 25
millirems per year (mrem/yr) or more, and; (2) transfer of authority to
TOSHA is free from regulatory gaps and does not diminish the safety and
health protection of the employees.
    Accordingly, TOSHA accepts and maintains health and safety
regulatory authority over employees in the vicinity of the Land Parcel
Powerhouse Area, Duct Island, K-1007-P1 Pond Area at the East Tennessee
Technology Park (ETTP).

III. Authority and Signature

    Loren Sweatt, Principal Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice. This Federal Register notice provides public notice and serves
as an addendum to the 1992 OSHA/DOE MOU. Accordingly, the agency is
issuing this notice pursuant to Section 8(g)(2) of the Occupational
Health and Safety Act of 1970 (29 U.S.C. 657(g)(2)), Secretary of
Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012).

    Signed at Washington, DC, on June 30, 2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2020-14839 Filed 7-9-20; 8:45 am]
BILLING CODE 4510-26-P