230.902(k) constitute less than 10 percent of the total number of trust
or fiduciary accounts of the foreign branch.
    (2) Rules of construction. Solely for purposes of this paragraph
(c), a bank will be deemed to have reasonable cause to believe that a
trust or fiduciary account of a foreign branch of the bank is not held
by or for the benefit of a U.S. person if
    (i) The principal mailing address maintained and used by the
foreign branch for the accountholder(s) and beneficiary(ies) of the
account is not in the United States; or
    (ii) The records of the foreign branch indicate that the
accountholder(s) and beneficiary(ies) of the account is not a U.S.
person as defined in 17 CFR 230.902(k).
    (3) Non-shell foreign branch. Solely for purposes of this paragraph
(c), a non-shell foreign branch of a bank means a branch of the bank
    (i) That is located outside the United States and provides banking
services to residents of the foreign jurisdiction in which the branch
is located; and
    (ii) For which the decisions relating to day-to-day operations and
business of the branch are made at that branch and are not made by an
office of the bank located in the United States.
    (d) Accounts transferred to a broker or dealer or other
unaffiliated entity. Notwithstanding section 3(a)(4)(B)(ii)(I) of the
Act (15 U.S.C. 78c(a)(4)(B)(ii)(I)) and Sec.  ----.721(a)(1) of this
part, a bank operating under Sec.  ----.721(a)(1) shall not be
considered a broker for purposes of section 3(a)(4) of the Act (15
U.S.C. 78c(a)(4)) solely because a trust or fiduciary account does not
meet the chiefly compensated standard in Sec.  ----.721(a)(1) if,
within 3 months of the end of the year in which the account fails to
meet such standard, the bank transfers the account or the securities
held by or on behalf of the account to a broker or dealer registered
under section 15 of the Act (15 U.S.C. 78o) or another entity that is
not an affiliate of the bank and is not required to be registered as a
broker or dealer.
    (e) De minimis exclusion. A bank may, in determining its compliance
with the chiefly compensated test in Sec.  ----.721(a)(1), exclude a
trust or fiduciary account if:
    (1) The bank maintains records demonstrating that the securities
transactions conducted by or on behalf of the account were undertaken
by the bank in the exercise of its trust or fiduciary responsibilities
with respect to the account;
    (2) The total number of accounts excluded by the bank under this
paragraph (d) does not exceed the lesser of--
    (i) 1 percent of the total number of trust or fiduciary accounts
held by the bank, provided that if the number so obtained is less than
1 the amount shall be rounded up to 1; or
    (ii) 500; and

    (3) The bank did not rely on this paragraph (d) with respect to
such account during the immediately preceding year.

Sec.  ----.740  Defined terms relating to the sweep accounts exception
from the definition of ``broker.''

    For purposes of section 3(a)(4)(B)(v) of the Act (15 U.S.C.
78c(a)(4)(B)(v)), the following terms shall have the meaning provided:
    (a) Deferred sales load has the same meaning as in 17 CFR 270.6c-
10.
    (b) Money market fund means an open-end company registered under
the Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.) that is
regulated as a money market fund pursuant to 17 CFR 270.2a-7.
    (c)(1) No-load, in the context of an investment company or the
securities issued by an investment company, means, for securities of
the class or series in which a bank effects transactions, that:
    (i) That class or series is not subject to a sales load or a
deferred sales load; and
    (ii) Total charges against net assets of that class or series of
the investment company's securities for sales or sales promotion
expenses, for personal service, or for the maintenance of shareholder
accounts do not exceed 0.25 of 1% of average net assets annually.
    (2) For purposes of this definition, charges for the following will
not be considered charges against net assets of a class or series of an
investment company's securities for sales or sales promotion expenses,
for personal service, or for the maintenance of shareholder accounts:
    (i) Providing transfer agent or sub-transfer agent services for
beneficial owners of investment company shares;
    (ii) Aggregating and processing purchase and redemption orders for
investment company shares;
    (iii) Providing beneficial owners with account statements showing
their purchases, sales, and positions in the investment company;
    (iv) Processing dividend payments for the investment company;
    (v) Providing sub-accounting services to the investment company for
shares held beneficially;
    (vi) Forwarding communications from the investment company to the
beneficial owners, including proxies, shareholder reports, dividend and
tax notices, and updated prospectuses; or
    (vii) Receiving, tabulating, and transmitting proxies executed by
beneficial owners of investment company shares.
    (d) Open-end company has the same meaning as in section 5(a)(1) of
the Investment Company Act of 1940 (15 U.S.C. 80a-5(a)(1)).
    (e) Sales load has the same meaning as in section 2(a)(35) of the
Investment Company Act of 1940 (15 U.S.C. 80a-2(a)(35)).

Sec.  ----.741  Exemption for banks effecting transactions in money
market funds.

    (a) A bank is exempt from the definition of the term ``broker''
under section 3(a)(4) of the Act (15 U.S.C. 78c(a)(4)) to the extent
that it effects transactions on behalf of a customer in securities
issued by a money market fund, provided that:
    (1) The bank either
    (A) Provides the customer, directly or indirectly, any other
product or service, the provision of which would not, in and of itself,
require the bank to register as a broker or dealer under section 15(a)
of the Act (15 U.S.C. 78o(a)); or
    (B) Effects the transactions on behalf of another bank as part of a
program for the investment or reinvestment of deposit funds of, or
collected by, the other bank; and
    (2)(i) The class or series of securities is no-load; or
    (ii) If the class or series of securities is not no-load
    (A) The bank or, if applicable, the other bank described in
paragraph (a)(1)(B) of this section provides the customer, not later
than at the time the customer authorizes the securities transactions, a
prospectus for the securities; and
    (B) The bank and, if applicable, the other bank described in
paragraph (a)(1)(B) of this section do not characterize or refer to the
class or series of securities as no-load.
    (b) Definitions. For purposes of this section:
    (1) Money market fund has the same meaning as in Sec.  ----.740(b).
    (2) No-load has the same meaning as in Sec.  ----.740(c).

Sec.  ----.760  Exemption from definition of ``broker'' for banks
accepting orders to effect transactions in securities from or on behalf
of custody accounts.

    (a) Employee benefit plan accounts and individual retirement
accounts or similar accounts. A bank is exempt from the definition of
the term ``broker'' under section 3(a)(4) of the Act (15 U.S.C.
78c(a)(4)) to the extent that, as part of its customary banking
activities, the bank accepts orders to effect transactions in
securities for an employee benefit plan account or an individual
retirement account or similar account for which the bank acts as a
custodian if:
    (1) Employee compensation restriction and additional conditions.
The bank complies with the employee compensation restrictions in
paragraph (c) of this section and the other conditions in paragraph (d)
of this section;
    (2) Advertisements. Advertisements by or on behalf of the bank do
not:
    (i) Advertise that the bank accepts orders for securities
transactions for employee benefit plan accounts or individual
retirement accounts or similar accounts, except as part of advertising
the other custodial or safekeeping services the bank provides to these
accounts; or
    (ii) Advertise that such accounts are securities brokerage accounts
or that the bank's safekeeping and custody services substitute for a
securities brokerage account; and
    (3) Advertisements and sales literature for individual retirement
or similar accounts. Advertisements and sales literature issued by or
on behalf of the bank do not describe the securities order-taking
services provided by the bank to individual retirement accounts or
similar accounts more prominently than the other aspects of the custody
or safekeeping services provided by the bank to these accounts.
    (b) Accommodation trades for other custodial accounts. A bank is
exempt from the definition of the term ``broker'' under section 3(a)(4)
of the Act (15 U.S.C. 78c(a)(4)) to the extent that, as part of its
customary banking activities, the bank accepts orders to effect
transactions in securities for an account for which the bank acts as
custodian other than an employee benefit plan account or an individual
retirement account or similar account if:
    (1) Accommodation. The bank accepts orders to effect transactions
in securities for the account only as an accommodation to the customer;
    (2) Employee compensation restriction and additional conditions.
The bank complies with the employee compensation restrictions in
paragraph (c) of this section and the other conditions in paragraph (d)
of this section;
    (3) Bank fees. Any fee charged or received by the bank for
effecting a securities transaction for the account does not vary based
on:
    (i) Whether the bank accepted the order for the transaction; or
    (ii) The quantity or price of the securities to be bought or sold;
    (4) Advertisements. Advertisements by or on behalf of the bank do
not state that the bank accepts orders for securities transactions for
the account;
    (5) Sales literature. Sales literature issued by or on behalf of
the bank:

    (i) Does not state that the bank accepts orders for securities
transactions for the account except as part of describing the other
custodial or safekeeping services the bank provides to the account; and
    (ii) Does not describe the securities order-taking services
provided to the account more prominently than the other aspects of the
custody or safekeeping services provided by the bank to the account;
and
    (6) Investment advice and recommendations. The bank does not
provide investment advice or research concerning securities to the
account, make recommendations to the account concerning securities or
otherwise solicit securities transactions from the account; provided,
however, that nothing in this paragraph (b)(6) shall prevent a bank
from:
    (i) Publishing, using or disseminating advertisements and sales
literature in accordance with paragraphs (b)(4) and (b)(5) of this
section; and
    (ii) Responding to customer inquiries regarding the bank's
safekeeping and custody services by providing:
    (A) Advertisements or sales literature consistent with the
provisions of paragraphs (b)(4) and (b)(5) of this section describing
the safekeeping, custody and related services that the bank offers;
    (B) A prospectus prepared by a registered investment company, or
sales literature prepared by a registered investment company or by the
broker or dealer that is the principal underwriter of the registered
investment company pertaining to the registered investment company's
products;
    (C) Information based on the materials described in paragraphs
(b)(6)(ii)(A) and (B) of this section; or
    (iii) Responding to inquiries regarding the bank's safekeeping,
custody or other services, such as inquiries concerning the customer's
account or the availability of sweep or other services, so long as the
bank does not provide investment advice or research concerning
securities to the account or make a recommendation to the account
concerning securities.
    (c) Employee compensation restriction. A bank may accept orders
pursuant to this section for a securities transaction for an account
described in paragraph (a) or (b) of this section only if no bank
employee receives compensation, including a fee paid pursuant to a plan
under 17 CFR 270.12b-1, from the bank, the executing broker or dealer,
or any other person that is based on whether a securities transaction
is executed for the account or that is based on the quantity, price, or
identity of securities purchased or sold by such account, provided that
nothing in this paragraph shall prohibit a bank employee from receiving
compensation that would not be considered incentive compensation under
Sec.  ----.700(b)(1) as if a referral had been made by the bank
employee, or any compensation described in Sec.  ----.700(b)(2).
    (d) Other conditions. A bank may accept orders for a securities
transaction for an account for which the bank acts as a custodian under
this section only if the bank:
    (1) Does not act in a trustee or fiduciary capacity (as defined in
section 3(a)(4)(D) of the Act (15 U.S.C. 78c(a)(4)(D)) with respect to
the account, other than as a directed trustee;
    (2) Complies with section 3(a)(4)(C) of the Act (15 U.S.C.
78c(a)(4)(C)) in handling any order for a securities transaction for
the account; and
    (3) Complies with section 3(a)(4)(B)(viii)(II) of the Act (15
U.S.C. 78c(a)(4)(B)(viii)(II)) regarding carrying broker activities.
    (e) Non-fiduciary administrators and recordkeepers. A bank that
acts as a non-fiduciary and non-custodial administrator or recordkeeper
for an employee benefit plan account for which another bank acts as
custodian may rely on the exemption provided in this section if:
    (1) Both the custodian bank and the administrator or recordkeeper
bank comply with paragraphs (a), (c) and (d) of this section; and
    (2) The administrator or recordkeeper bank does not execute a
cross-trade with or for the employee benefit plan account or net orders
for securities for the employee benefit plan account, other than:
    (i) Crossing or netting orders for shares of open-end investment
companies not traded on an exchange, or
    (ii) Crossing orders between or netting orders for accounts of the
custodian bank that contracted with the administrator or recordkeeper
bank for services.
    (f) Subcustodians. A bank that acts as a subcustodian for an
account for which another bank acts as custodian may rely on the
exemptions provided in this section if:
    (1) For employee benefit plan accounts and individual retirement
accounts or similar accounts, both the custodian bank and the
subcustodian bank meet the requirements of paragraphs (a), (c) and (d)
of this section;
    (2) For other custodial accounts, both the custodian bank and the
subcustodian bank meet the requirements of paragraphs (b), (c) and (d)
of this section; and
    (3) The subcustodian bank does not execute a cross-trade with or
for the account or net orders for securities for the account, other
than:
    (i) Crossing or netting orders for shares of open-end investment
companies not traded on an exchange, or
    (ii) Crossing orders between or netting orders for accounts of the
custodian bank.
    (g) Evasions. In considering whether a bank meets the terms of this
section, both the form and substance of the relevant account(s),
transaction(s) and activities (including advertising activities) of the
bank will be considered in order to prevent evasions of the
requirements of this section.
    (h) Definitions. When used in this section:
    (1) Account for which the bank acts as a custodian means an account
that is:
    (i) An employee benefit plan account for which the bank acts as a
custodian;
    (ii) An individual retirement account or similar account for which
the bank acts as a custodian;
    (iii) An account established by a written agreement between the
bank and the customer that sets forth the terms that will govern the
fees payable to, and rights and obligations of, the bank regarding the
safekeeping or custody of securities; or
    (iv) An account for which the bank acts as a directed trustee.
    (2) Advertisement means any material that is published or used in
any electronic or other public media, including any Web site,
newspaper, magazine or other periodical, radio, television, telephone
or tape recording, videotape display, signs or billboards, motion
pictures, or telephone directories (other than routine listings).
    (3) Directed trustee means a trustee that does not exercise
investment discretion with respect to the account.
    (4) Employee benefit plan account means a pension plan, retirement
plan, profit sharing plan, bonus plan, thrift savings plan, incentive
plan, or other similar plan, including, without limitation, an
employer-sponsored plan qualified under section 401(a) of the Internal
Revenue Code (26 U.S.C. 401(a)), a governmental or other plan described
in section 457 of the Internal Revenue Code (26 U.S.C. 457), a tax-
deferred plan described in section 403(b) of the Internal Revenue Code
(26 U.S.C. 403(b)), a church plan, governmental, multiemployer or other
plan described in section 414(d), (e) or (f) of the Internal Revenue
Code (26 U.S.C. 414(d), (e) or (f)), an incentive

stock option plan described in section 422 of the Internal Revenue Code
(26 U.S.C. 422); a Voluntary Employee Beneficiary Association Plan
described in section 501(c)(9) of the Internal Revenue Code (26 U.S.C.
501(c)(9)), a non-qualified deferred compensation plan (including a
rabbi or secular trust), a supplemental or mirror plan, and a
supplemental unemployment benefit plan.
    (5) Individual retirement account or similar account means an
individual retirement account as defined in section 408 of the Internal
Revenue Code (26 U.S.C. 408), Roth IRA as defined in section 408A of
the Internal Revenue Code (26 U.S.C. 408A), health savings account as
defined in section 223(d) of the Internal Revenue Code (26 U.S.C.
223(d)), Archer medical savings account as defined in section 220(d) of
the Internal Revenue Code (26 U.S.C. 220(d)), Coverdell education
savings account as defined in section 530 of the Internal Revenue Code
(26 U.S.C. 530), or other similar account.
    (6) Sales literature means any written or electronic communication,
other than an advertisement, that is generally distributed or made
generally available to customers of the bank or the public, including
circulars, form letters, brochures, telemarketing scripts, seminar
texts, published articles, and press releases concerning the bank's
products or services.
    (7) Principal underwriter has the same meaning as in section
2(a)(29) of the Investment Company Act of 1940 (15 U.S.C. 80a-
2(a)(29)).

Sec.  --.771  Exemption from the definition of ``broker'' for banks
effecting transactions in securities issued pursuant to Regulation S.

    (a) A bank is exempt from the definition of the term ``broker''
under section 3(a)(4) of the Act (15 U.S.C. 78c(a)(4)), to the extent
that, as agent, the bank:
    (1) Effects a sale in compliance with the requirements of 17 CFR
230.903 of an eligible security to a purchaser who is not in the United
States;
    (2) Effects, by or on behalf of a person who is not a U.S. person
under 17 CFR 230.902(k), a resale of an eligible security after its
initial sale with a reasonable belief that the eligible security was
initially sold outside of the United States within the meaning of and
in compliance with the requirements of 17 CFR 230.903 to a purchaser
who is not in the United States or a registered broker or dealer,
provided that if the resale is made prior to the expiration of any
applicable distribution compliance period specified in 17 CFR
230.903(b)(2) or (b)(3), the resale is made in compliance with the
requirements of 17 CFR 230.904; or
    (3) Effects, by or on behalf of a registered broker or dealer, a
resale of an eligible security after its initial sale with a reasonable
belief that the eligible security was initially sold outside of the
United States within the meaning of and in compliance with the
requirements of 17 CFR 230.903 to a purchaser who is not in the United
States, provided that if the resale is made prior to the expiration of
any applicable distribution compliance period specified in 17 CFR
230.903(b)(2) or (b)(3), the resale is made in compliance with the
requirements of 17 CFR 230.904.
    (b) Definitions. For purposes of this section:
    (1) Distributor has the same meaning as in 17 CFR 230.902(d).
    (2) Eligible security means a security that:
    (i) Is not being sold from the inventory of the bank or an
affiliate of the bank; and
    (ii) Is not being underwritten by the bank or an affiliate of the
bank on a firm-commitment basis, unless the bank acquired the security
from an unaffiliated distributor that did not purchase the security
from the bank or an affiliate of the bank.
    (3) Purchaser means a person who purchases an eligible security and
who is not a U.S. person under 17 CFR 230.902(k).

Sec.  ----.772  Exemption from the definition of ``broker'' for banks
engaging in securities lending transactions.

    (a) A bank is exempt from the definition of the term ``broker''
under section 3(a)(4) of the Act (15 U.S.C. 78c(a)(4)), to the extent
that, as an agent, it engages in or effects securities lending
transactions, and any securities lending services in connection with
such transactions, with or on behalf of a person the bank reasonably
believes to be:
    (1) A qualified investor as defined in section 3(a)(54)(A) of the
Act (15 U.S.C. 78c(a)(54)(A)); or
    (2) Any employee benefit plan that owns and invests on a
discretionary basis, not less than $ 25,000,000 in investments.
    (b) Securities lending transaction means a transaction in which the
owner of a security lends the security temporarily to another party
pursuant to a written securities lending agreement under which the
lender retains the economic interests of an owner of such securities,
and has the right to terminate the transaction and to recall the loaned
securities on terms agreed by the parties.
    (c) Securities lending services means:
    (1) Selecting and negotiating with a borrower and executing, or
directing the execution of the loan with the borrower;
    (2) Receiving, delivering, or directing the receipt or delivery of
loaned securities;
    (3) Receiving, delivering, or directing the receipt or delivery of
collateral;
    (4) Providing mark-to-market, corporate action, recordkeeping or
other services incidental to the administration of the securities
lending transaction;
    (5) Investing, or directing the investment of, cash collateral; or
    (6) Indemnifying the lender of securities with respect to various
matters.

Sec.  ----.775  Exemption from the definition of ``broker'' for banks
effecting certain excepted or exempted transactions in investment
company securities.

    (a) A bank that meets the conditions for an exception or exemption
from the definition of the term ``broker'' except for the condition in
section 3(a)(4)(C)(i) of the Act (15 U.S.C. 78c(a)(4)(C)(i)), is exempt
from such condition to the extent that it effects a transaction in a
covered security, if:
    (1) Any such security is neither traded on a national securities
exchange nor through the facilities of a national securities
association or an interdealer quotation system;
    (2) The security is distributed by a registered broker or dealer,
or the sales charge is no more than the amount permissible for a
security sold by a registered broker or dealer pursuant to any
applicable rules adopted pursuant to section 22(b)(1) of the Investment
Company Act of 1940 (15 U.S.C. 80a-22(b)(1)) by a securities
association registered under section 15A of the Act (15 U.S.C. 78o-3);
and
    (3) Any such transaction is effected:
    (i) Through the National Securities Clearing Corporation; or
    (ii) Directly with a transfer agent or with an insurance company or
separate account that is excluded from the definition of transfer agent
in Section 3(a)(25) of the Act.
    (b) Definitions. For purposes of this section:
    (1) Covered security means:
    (i) Any security issued by an open-end company, as defined by
section 5(a)(1) of the Investment Company Act (15 U.S.C. 80a5(a)(1)),
that is registered under that Act; and
    (ii) Any variable insurance contract funded by a separate account,
as defined by section 2(a)(37) of the Investment Company Act (15 U.S.C.
80a-2(a)(37)), that is registered under that Act.

    (2) Interdealer quotation system has the same meaning as in 17 CFR
240.15c2-11.
    (3) Insurance company has the same meaning as in 15 U.S.C.
77b(a)(13).

Sec.  ----.776  Exemption from the definition of ``broker'' for banks
effecting certain excepted or exempted transactions in a company's
securities for its employee benefit plans.

    (a) A bank that meets the conditions for an exception or exemption
from the definition of the term ``broker'' except for the condition in
section 3(a)(4)(C)(i) of the Act (15 U.S.C. 78c(a)(4)(C)(i)), is exempt
from such condition to the extent that it effects a transaction in the
securities of a company directly with a transfer agent acting for the
company that issued the security, if:
    (1) No commission is charged with respect to the transaction;
    (2) The transaction is conducted by the bank solely for the benefit
of an employee benefit plan account;
    (3) Any such security is obtained directly from:
    (i) The company; or
    (ii) An employee benefit plan of the company; and
    (4) Any such security is transferred only to:
    (i) The company; or
    (ii) An employee benefit plan of the company.
    (b) For purposes of this section, the term employee benefit plan
account has the same meaning as in Sec.  ----.760(h)(4).

Sec.  ----.780  Exemption for banks from liability under section 29 of
the Securities Exchange Act of 1934.

    (a) No contract entered into before March 31, 2009, shall be void
or considered voidable by reason of section 29(b) of the Act (15 U.S.C.
78cc(b)) because any bank that is a party to the contract violated the
registration requirements of section 15(a) of the Act (15 U.S.C.
78o(a)), any other applicable provision of the Act, or the rules and
regulations thereunder based solely on the bank's status as a broker
when the contract was created.
    (b) No contract shall be void or considered voidable by reason of
section 29(b) of the Act (15 U.S.C. 78cc(b)) because any bank that is a
party to the contract violated the registration requirements of section
15(a) of the Act (15 U.S.C. 78o(a)) or the rules and regulations
thereunder based solely on the bank's status as a broker when the
contract was created, if:
    (1) At the time the contract was created, the bank acted in good
faith and had reasonable policies and procedures in place to comply
with section 3(a)(4)(B) of the Act (15 U.S.C. 78c(a)(4)(B)) and the
rules and regulations thereunder; and
    (2) At the time the contract was created, any violation of the
registration requirements of section 15(a) of the Act by the bank did
not result in any significant harm or financial loss or cost to the
person seeking to void the contract.

Sec.  ----.781  Exemption from the definition of ``broker'' for banks
for a limited period of time.

    A bank is exempt from the definition of the term ``broker'' under
section 3(a)(4) of the Act (15 U.S.C. 78c(a)(4)) until the first day of
its first fiscal year commencing after September 30, 2008.

    By order of the Board of Governors of the Federal Reserve
System, September 24, 2007.
Jennifer J. Johnson,
Secretary of the Board.
    Dated: September 24, 2007.

    By the Securities and Exchange Commission.
Nancy M. Morris,
Secretary.
[FR Doc. 07-4769 Filed 9-28-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 86 (Monday, May 4, 2020)]
[Notices]
[Pages 26456-26457]
[FR Doc No: 2020-09455]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0720; FRL-10008-08]

Pesticide Registration Review; Draft Human Health and/or
Ecological Risk Assessments for Several Rodenticides; Notice of
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's draft human
health and/or ecological risk assessments for the registration review
of brodifacoum, bromadiolone, bromethalin, cholecalciferol,
chlorophacinone, difenacoum, difethialone, diphacinone and diphacinone
sodium salt, and warfarin and warfarin sodium salt.

DATES: Comments must be received on or before July 6, 2020.

ADDRESSES: Submit your comments, to the docket identification (ID)
number for the specific pesticide of interest provided in the Table in
Unit IV, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, are available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For pesticide specific information contact: The Chemical Review
Manager for the pesticide of interest identified in the Table in Unit
IV.
    For general questions on the registration review program, contact:
Melanie Biscoe, Pesticide Re-Evaluation Division (7508P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager identified in the Table in Unit IV.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Background

    Registration review is EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, the pesticide can perform
its intended function without unreasonable adverse effects on human
health or the environment. As part of the registration review process,
the Agency has completed comprehensive draft human health and/or
ecological risk assessments for all pesticides listed in the Table in
Unit IV. After reviewing comments received during the public comment
period, EPA may issue a revised risk assessment, explain any changes to
the draft risk assessment, and

respond to comments and may request public input on risk mitigation
before completing a proposed registration review decision for the
pesticides listed in the Table in Unit IV. Through this program, EPA is
ensuring that each pesticide's registration is based on current
scientific and other knowledge, including its effects on human health
and the environment.

III. Authority

    EPA is conducting its registration review of the chemicals listed
in the Table in Unit IV pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
Section 3(g) of FIFRA provides, among other things, that the
registrations of pesticides are to be reviewed every 15 years. Under
FIFRA, a pesticide product may be registered or remain registered only
if it meets the statutory standard for registration given in FIFRA
section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with
widespread and commonly recognized practice, the pesticide product must
perform its intended function without unreasonable adverse effects on
the environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

IV. What action is the agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of EPA's human health and/or ecological risk assessments for the
pesticides shown in the following table and opens a 60-day public
comment period on the risk assessments.

  Table--Draft Risk Assessments Being Made Available for Public Comment
------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name    Docket ID No.     manager and contact
          and number                                    information
------------------------------------------------------------------------
Brodifacoum, Case 2755........  EPA-HQ-OPP-2015-0  Kent Fothergill,
                                 767<EMAIL_ADDRESS>703-347-8299.
Bromadiolone, Case 2760.......  EPA-HQ-OPP-2015-0  Kent Fothergill,
                                 768<EMAIL_ADDRESS>703-347-8299.
Bromethalin, Case 2765........  EPA-HQ-OPP-2016-0  Kent Fothergill,
                                 077<EMAIL_ADDRESS>703-347-8299.
Cholecalciferol, Case 7600....  EPA-HQ-OPP-2016-0  Kent Fothergill,
                                 139<EMAIL_ADDRESS>703-347-8299.
Chlorophacinone, Case 2100....  EPA-HQ-OPP-2015-0  Kent Fothergill,
                                 778<EMAIL_ADDRESS>703-347-8299.
Difenacoum, Case 7630.........  EPA-HQ-OPP-2015-0  Kent Fothergill,
                                 769<EMAIL_ADDRESS>703-347-8299.
Difethialone, Case 7603.......  EPA-HQ-OPP-2015-0  Kent Fothergill,
                                 770<EMAIL_ADDRESS>703-347-8299.
Diphacinone and Diphacinone     EPA-HQ-OPP-2015-0  Kent Fothergill,
 Sodium Salt, Case 2205.         777<EMAIL_ADDRESS>703-347-8299.
Warfarin and Warfarin Sodium    EPA-HQ-OPP-2015-0  Kent Fothergill,
 Salt, Case 0011.                481<EMAIL_ADDRESS>703-347-8299.
------------------------------------------------------------------------

    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity,
through this notice of availability, for interested parties to provide
comments and input concerning the Agency's draft human health and/or
ecological risk assessments for the pesticides listed in the Table in
Unit IV. The Agency will consider all comments received during the
public comment period and make changes, as appropriate, to a draft
human health and/or ecological risk assessment. EPA may then issue a
revised risk assessment, explain any changes to the draft risk
assessment, and respond to comments.

Information Submission Requirements

    Anyone may submit data or information in response to this document.
To be considered during a pesticide's registration review, the
submitted data or information must meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
    As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.

(Authority: 7 U.S.C. 136 et seq.)

    Dated: April 9, 2020.
Mary Reaves,
Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2020-09455 Filed 5-1-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 15, 2008 (Volume 73, Number 73)]
[Notices]
[Page 20309-20311]
[DOCID:fr15ap08-91]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0225]

Antimicrobial Resistance; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a

public hearing on antimicrobial resistance. FDA is seeking general
information about the problem of antimicrobial resistance,
recommendations as to possible approaches to contain the problem of
antimicrobial resistance, responses to specific questions (see section
III of this document), and other pertinent information from interested
parties. In addition, interested parties may provide views on which
serious and life-threatening infectious diseases, such as diseases due
to gram-negative bacteria and other diseases due to antimicrobial-
resistant bacteria, potentially qualify for available grants and
contracts or other development incentives.

DATES: The public hearing will be held April 28, 2008, from 8 a.m. to 5
p.m. Submit written or electronic notices of participation by close of
business on April 21, 2008. Written or electronic comments will be
accepted until May 26, 2008.

ADDRESSES: The public hearing will be held at the University System of
Maryland Shady Grove Center, 9630 Gudelsky Dr., Rockville, MD 20850.
    See Registration to Attend and/or Participate in the Public Hearing
for instructions on how to submit electronic notices of participation.
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nancy Stanisic, Office of Critical
Path Programs (HF-18), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>, FAX<PHONE_NUMBER>,
<EMAIL_ADDRESS>Registration to Attend and/or Participate in the Public Hearing: To
ensure there is sufficient room we ask that you pre-register. If you
wish to make an oral presentation during the open public comment period
of the hearing, state your intention to present on your registration
submission. To register, please send an electronic mail message to
<EMAIL_ADDRESS>by April 21, 2008. Your e-mail should include
the following information:
     Your name,
     Title,
     Business affiliation,
     Address,
     Telephone and fax numbers, and e-mail address.
    Please submit a written statement at the time of registration,
identifying by number each discussion question you wish to address and
the approximate time requested to make your presentation. Organizations
should provide this information as well as the names and addresses of
all participants. Registered individuals will be notified of the
scheduled time for their presentation prior to the hearing. Depending
on the number of presentations, FDA may need to limit the time allotted
for presentations. However, the administrative record of the hearing
will remain open after the hearing, and written comments may be
submitted to the docket as described in section V of this document.
Presentations will be limited to the subject matter identified in
section III of this document.
    FDA will accept walk-in registration at the site, but space is
limited. FDA will try to accommodate all persons who wish to make a
public comment at the hearing, including those who register at the
site. Registration is on a first-come, first-served basis.
    Additionally, please notify FDA (see FOR FURTHER INFORMATION
CONTACT) if you need any special accommodations (such as wheelchair
access) at the time of registration.

SUPPLEMENTARY INFORMATION:

I. Background

    Antimicrobial drug resistance is a major public health concern and
a threat to the effectiveness of existing antimicrobial drugs.
Antimicrobial resistant pathogens continue to emerge that are very
difficult to treat and that may cause serious or life-threatening
diseases. Emerging antimicrobial resistance among many bacteria (e.g.,
Pseudomonas species, Acinetobacter species, Enterococcus species,
Staphylococcus aureus, Streptococcus pneumoniae, and Mycobacterium
tuberculosis) and changes in virulence (e.g., Clostridium difficile,
group A Streptococci, Escherichia coli O157:H7, and Staphylococcus
aureus) are major public health concerns. Timely development of new
therapeutic agents is essential and use of existing therapies to treat
infections caused by these organisms should be optimized to preserve
their utility in treating infections and reduce the rate at which
resistance develops.
    FDA has been working closely with other Government agencies and
organizations to address the issue of antimicrobial resistance. An
interagency Task Force began looking at antimicrobial resistance in
1999, and developed and published the Public Health Action Plan to
Combat Antimicrobial Resistance (Action Plan) (available at http://
www.cdc.gov/drugresistance/actionplan/html/index.htm).\1\ FDA also
published a final rule in February 2003 that requires incorporation of
information on antimicrobial resistance and prudent use in the labeling
of systemic antibacterial drug products for human use (68 FR 6062,
February 6, 2003). FDA has held or participated in a number of meetings
on antimicrobial resistance, including an Anti-Infective Drugs Products
Advisory Committee in March 2003, an Infectious Diseases Society of
America/International Society of Anti-Infective Pharmacology/FDA
Workshop on Antimicrobial Drug Development in April 2004, and an FDA
Science Board Advisory Committee meeting on the Center for Veterinary
Medicine's National Antimicrobial Resistance Monitoring System in April
2007.
---------------------------------------------------------------------------

    \1\ (FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)
---------------------------------------------------------------------------

    In September 2007, Congress passed the Food and Drug Administration
Amendments Act (FDAAA), which was signed into law by the President on
September 27, 2007 (Public Law 110-85). Section 1112 (Orphan Antibiotic
Drugs) of FDAAA requires the Commissioner of Food and Drugs (the
Commissioner) to convene a public hearing to discuss which serious and
life-threatening infectious diseases, such as diseases caused by gram-
negative bacteria and other diseases due to antibiotic-resistant
bacteria, potentially qualify for available grants and contracts under
section 5(a) of the Orphan Drug Act (21 U.S.C. 360ee(a)) or other
incentives. For this reason, FDA is holding this public hearing.
    Under the Orphan Drug Act (Public Law 97-414), a drug is an orphan
drug if it is intended for use in a rare disease or condition. Sponsors
of orphan drugs are eligible for certain research and development
incentives. During the period that an orphan drug is in development,
the sponsor may be awarded grant funding to defray the cost of
qualified clinical testing incurred in connection with the development
of the drug for a rare disease or condition. A drug that has been
designated as an orphan drug by FDA may receive 7 years of marketing
exclusivity for the drug for the designated orphan use upon approval.
To receive designation as an orphan drug (as defined in section 526 of
the Federal Food, Drug, and Cosmetic Act) (21 U.S.C. 360bb)), a sponsor
must meet the requirements in 21 CFR 316.20

and 316.21. These requirements include, but are not limited to,
documentation of the following:
     The disease or condition for which the drug is intended
affects fewer than 200,000 people in the United States (e.g.,
tuberculosis, malaria, trypanosomiasis).
     If the drug is a vaccine, diagnostic drug, or preventative
drug, the persons to whom the drug will be administered in the United
States are fewer than 200,000 per year.
     For a drug intended for diseases or conditions affecting
200,000 or more people, or for a vaccine, diagnostic drug, or
preventative drug to be administered to 200,000 or more persons per
year in the United States, there is no reasonable expectation that
costs of research and development of the drug for the indication can be
recovered by sales of the drug in the United States.
    Antimicrobial drugs that have qualified for orphan drug designation
in the past include some indicated for the treatment of tuberculosis,
malaria, and trypanosomiasis.

II. Purpose and Scope of the Hearing

    This hearing is intended to provide the infectious disease
community, sponsors, and other interested parties an opportunity to
discuss their experience with and concerns about the emerging threat of
antimicrobial resistance, possible strategies fostering prudent use to
prevent the development of antimicrobial resistance, and the potential
for the provisions of the Orphan Drug Act or other incentives to
facilitate antimicrobial drug development, including what, if any,
conditions might be required to accompany such incentives.

III. Issues for Discussion

    FDA invites comments from interested parties on the following
questions:
    1. Please discuss strategies that should be considered to limit the
development of antimicrobial resistance, and studies that could be done
to assess the utility, safety and effectiveness of those strategies.
Possible examples include limiting the approved conditions of use,
limiting the duration of therapy, restricting distribution to encourage
appropriate use, using shorter courses of therapy with higher doses of
antimicrobials, and using directly observed therapy.
    2. Please discuss the possible utility and effectiveness of
economic incentives in promoting drug development for antimicrobial
resistant organisms.
    a. What is the potential role of the Orphan Drug Act in providing
incentives to facilitate antimicrobial drug development? Please
describe the serious and life-threatening infectious diseases for which
the Orphan Drug Act provides viable research and development
incentives. Please comment on the potential complexities associated
with identifying appropriate orphan populations in the infectious
disease context.
    b. Are there specific incentives (other than those provided by the
Orphan Drug Act) that could facilitate the development of new
antimicrobial therapies for serious and life-threatening diseases?
Describe those serious and life-threatening infectious diseases, such
as diseases due to gram-negative bacteria and other diseases due to
antimicrobial-resistant bacteria, which could be considered under an
alternative incentive program.

IV. Notice of Hearing Under 21 CFR Part 15

    The Commissioner is announcing that the public hearing will be held
in accordance with part 15 (21 CFR part 15). The hearing will be
conducted by a presiding officer, accompanied by FDA senior management
from the Office of the Commissioner, the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research, and FDA's
Office of Orphan Drugs.
    Under Sec.  15.30(f), the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
    Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10), subpart C)). Under Sec.  10.205,
representatives of the electronic media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b).
    To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of those provisions as specified in 21 CFR
15.30(h).

V. Request for Comments

    Regardless of attendance at the public hearing, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments should be identified with the docket
number found in brackets in the heading of this document. To ensure
consideration, submit comments by (see DATES). Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.

VI. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
It may be viewed at the Division of Dockets Management (see ADDRESSES).
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: April 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. 08-1129 Filed 4-10-08; 12:23 pm]

BILLING CODE 4160-01-S


[Federal Register Volume 78, Number 121 (Monday, June 24, 2013)]
[Notices]
[Pages 37804-37805]
[FR Doc No: 2013-15024]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0665; FRL-9533-7]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Magnetic Tape
Manufacturing Operations (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before July 24, 2013.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2012-0665, to: (1) EPA online, using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460; and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On October 17, 2012 (77 FR 63813), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to both EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number

EPA-HQ-OECA-2012-0665, which is available for either public viewing
online at http://www.regulations.gov, or in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov to either submit or view public comments, access
the index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidentiality of Business Information (CBI), or
other information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to
www.regulations.gov.
    Title: NESHAP for Magnetic Tape Manufacturing Operations (Renewal).
    ICR Numbers: EPA ICR Number 1678.08, OMB Control Number 2060-0326.
    ICR Status: This ICR is scheduled to expire on June 30, 2013. Under
OMB regulations, the Agency may continue to either conduct or sponsor
the collection of information while this submission is pending at OMB.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP at 40 CFR part 63, subpart A, and any changes,
or additions to the Provisions specified at 40 CFR part 63, subpart EE.
    Owners or operators of the affected facilities must submit initial
notification, performance tests, and periodic reports and results.
Owners or operators are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. Reports are required semiannually at
a minimum.
    Respondents/Affected Entities: Magnetic tape manufacturing
operations.
    Estimated Number of Respondents: 6.
    Frequency of Response: Initially, occasionally, quarterly,
semiannually and annually.
    Estimated Total Annual Hour Burden: 3,905. ``Burden'' is defined at
5 CFR 1320.3(b).
    Estimated Total Annual Cost: $425,110, which includes $378,110 in
labor costs, $11,000 in capital/startup costs, and $36,000 in operation
and maintenance (O&M) costs.
    Changes in the Estimates: The increase in burden from the most
recently-approved ICR is due to an adjustment in labor rates and
updated assumptions used to estimate technical hours per year. This ICR
uses updated labor rates from the Bureau of Labor Statistics to
calculate burden costs.
    In addition to updated labor rates, there is an update to the
assumptions used to estimate technical hours per year for the
calculated burden costs. In the previous ICR, it was assumed that the
per respondent burden hour for each activity accounts for technical,
managerial, and clerical hours. In order to have consistency in the
burden calculations in the ICR renewal process, this ICR assumes the
per respondent burden hour accounts for technical hours only. This
results in a slight increase in burden hours and costs for both the
respondents and the Agency.

Richard T. Westlund,
Acting Director, Collection Strategies Division.
[FR Doc. 2013-15024 Filed 6-21-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Notices]
[Pages 68673-68675]
[FR Doc No: 2021-26261]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0921]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Standards for the Growing, Harvesting, Packaging, 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 the 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 February 1, 2022.

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 February 1, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 1, 2022. 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-2011-N-0921 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Standards for the Growing,
Harvesting, Packaging, 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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--Extension

    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 regulations are followed such that produce
entering the marketplace is reasonably unlikely to be associated with
foodborne illness.
    In addition to the referenced regulations, we have developed two
draft guidance documents: ``Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption'' and
``Compliance with and Recommendations for Implementation of the
Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption for Sprout Operations;'' both are available at
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm. The former was
developed to help covered farms comply with the requirements of the
Produce Safety regulation. This draft guidance, when finalized, will
not create any additional burden not already considered as part of the
Produce Safety regulation.
    The latter (the Sprouts draft guidance) was developed to assist
sprout operations also subject to the Produce Safety regulation.
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 Sprouts draft guidance, when finalized, will assist sprout
operations subject to the regulations in part 112 in complying 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 this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
           Activity; 21 CFR section               Number of        records per     Total annual        Average burden per recordkeeping      Total hours
                                                recordkeepers   recordkeeper \2\      records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 agricultural water             48,361             2.990         144,599  0.825 (~ 50 minutes).....................      119,294
 under Sec.  Sec.   112.44 and 112.45.
Records related to agricultural water........          160,605             2.242         360,076  2.160....................................      777,765
Testing requirements for sprouts under Sec.                126           245.660       30,953.16  0.825 (~ 50 minutes).....................       25,536
 Sec.   112.144, 112.145, and 112.147.
Records related to sprouts...................              126            62.061       7,819.686  1.412 (~ 85 minutes).....................       11,041
``Compliance with and Recommendations for                  126               233          29,358  1........................................       29,358
 Implementation of the Standards for the
 Growing, Harvesting, Packing, and Holding of
 Produce for Human Consumption for Sprout
 Operations''.
Documentation supporting compliance with Sec.            4,568                 1           4,568  0.079 (~ 5 minutes)......................          361
   112.2.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................          241,617  ................         605,079  .........................................    1,142,043
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers rounded to nearest 1/1,000.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
                21 CFR section                    Number of      disclosures per       Total            Average burden per disclosure        Total hours
                                                 respondents       Respondent       disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosure under Sec.  Sec.   112.2, 112.6,             77,165             3.459         266,914  1.422 (~ 85 minutes).....................      379,551
 112.31, 112.33, and 112.142.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating or maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: November 23, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26261 Filed 12-2-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36482-36483]
[FR Doc No: 2022-13114]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-2091-000]

Calhoun Solar Energy LLC ; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Calhoun Solar Energy LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 5, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    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.
    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 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 the Federal Energy Regulatory Commission at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.

    Dated: June 13, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-13114 Filed 6-16-22; 8:45 am]
BILLING CODE 6717-01-P


BSEF

Bromine Science and Environmental Forum Avenue de Cortenbergh, 118

1000 Brussels

Belgium

Phone 32 2 733 93 70

Fax 32 2 735 60 63

websites www. bsef. com

www. firesafetyinfo. org

E mail mail@ BSEF. com Major Brominated Flame Retardants Volume Estimates Total Market Demand By Region in 2001 [ MT] Americas Europe Asia Rest of World Total TBBPA 18,000 11,600 89,400 600 119,700 HBCD 2,800 9,500 3,900 500 16,700 Deca BDE ( DBDPO) 24,500 7,600 23,000 1,050 56,100 Octa BDE ( OBDPO) 1,500 610 1,500 180 3,790 Penta BDE ( PBDPO) 7,100 150 150 100 7,500 21 January 2003