[Federal Register: May 2, 2007 (Volume 72, Number 84)]
[Notices]
[Page 24344-24346]
[DOCID:fr02my07-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-27805; 812-13186]

HSBC Securities (USA) Inc.; Notice of Application

April 26, 2007.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of application under section 6(c) of the Investment
Company Act of 1940 (the ``Act'') for an exemption from section
18(f)(1) of the Act.

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Applicant: HSBC Securities (USA) Inc. (``HSBC Securities'').
Summary of Application: Applicant requests an order permitting
registered open-end management investment companies to enter into
secured loan transactions with commercial paper and medium-term note
conduits administered by HSBC Securities.

DATES: Filing Dates: The application was filed on May 2, 2005 and
amended on April 26, 2007.

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 by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on May 21, 2007, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street,
NE, Washington, DC 20549-1090. Applicant, c/o Timothy P. Mohan, Esq.,
Chapman and Cutler LLP, 111 West Monroe Street, Chicago, IL 60603.

FOR FURTHER INFORMATION CONTACT: Laura L. Solomon, Senior Counsel, at
(202) 551-6915, or Janet M. Grossnickle, Branch Chief, at (202) 551-
6821 (Division of Investment Management, Office of Investment Company
Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Desk, 100 F Street, NE, Washington, DC
20549-0102 (tel.<PHONE_NUMBER>).

Applicant's Representations

    1. HSBC Securities is an indirectly-held, wholly-owned subsidiary
of HSBC Holdings plc (``HSBC Holdings''), one of the largest banking
and financial services organizations in the world. HSBC Securities has
substantial experience and expertise as an administrator of asset-
backed commercial paper note programs. HSBC Securities has administered
Bryant Park Funding LLC (``Bryant Park''), a commercial paper note
program, since 2001 and has administered Abington Square Funding LLC
(``Abington'') since 2006. As of February 28, 2007, this commercial
paper program had assets of approximately $4.9 billion. HSBC Securities
expects to administer additional asset-backed commercial paper and
medium-term note programs established for additional limited purpose
securitization entities to be formed in the future (such HSBC
Securities administered conduits, collectively, along with Bryant Park
and Abington, the ``Conduits''). Applicant states that several
registered open-end investment companies have expressed interest in the
type of loan facility described in the application.
    2. Applicant requests relief to permit any registered open-end
management investment company or series thereof that may participate
from time to time as a borrower (``Borrowing Fund'') in loan facilities
administered by HSBC Securities (``Loan Facilities''). The Conduits,
which would be the principal source of financing for each Loan
Facility, will issue commercial paper and, in certain cases, may issue
medium-term notes (collectively, with the commercial paper,
``Promissory Notes'') and will use liquidity support provided by
financial institutions that are ``banks'' within the meaning of section
2(a)(5) of the Act (``Liquidity Providers'') in connection with a Loan
Facility. Each of Bryant Park and Abington is organized as a limited
liability company under the laws of Delaware. Each Conduit, other than
Bryant Park and Abington, will likely be organized as a corporation or
limited liability company under the laws of Delaware. The Conduits will
issue Promissory Notes to fund loans secured by receivables or other
financial assets of the borrowers.
    3. The Promissory Notes issued by the Conduits generally are sold
to institutional investors that are ``accredited investors'' as defined
in rule 501(a) of Regulation D under the Securities Act of 1933 (the
``Securities Act'') or ``qualified institutional buyers'' as defined in
rule 144A under the Securities Act. HSBC Securities will negotiate the
business arrangements on behalf of a Conduit, including loan amounts,
interest rates, and fees. HSBC Securities will act as agent for the
Conduits and the related Liquidity Providers under the agreements
entered into with each Borrowing Fund and in such capacity will
exercise rights and enforce remedies on behalf of the Conduit and
Liquidity Providers. Personnel employed by HSBC Securities have
substantially similar levels of experience and expertise as personnel
that administer loans backed by financial assets made by HSBC Bank USA,
National Association, which may act as a Liquidity Provider.
    4. As security for a loan, Borrowing Funds will pledge assets
(``Pledged Assets'') for the benefit of the Conduit and the Liquidity
Providers. The Pledged Assets will meet eligibility criteria set by the
Conduit and such criteria will be consistent with the Borrowing Fund's
investment objectives and policies. For each loan transaction, HSBC
Securities will evaluate: (a) The type and nature of a Borrowing Fund's
Pledged Assets to determine whether they meet the Conduit's standards
for collateral; (b) the operations and history of the Borrowing Fund;
and (c) the financial position and operations of the Borrowing Fund's
investment adviser.
    5. Applicant states that a Conduit would make loans to a Borrowing
Fund on an uncommitted basis and the related Liquidity Providers would,
subject to the terms of the Loan Facility, be obligated to make loans
to the Borrowing Fund in the event the Conduit was unable or unwilling
to make such loans. The Conduit at any time and for any reason may (a)
sell an outstanding loan to a Liquidity Provider, or (b) require a
Liquidity Provider to provide financing to a Borrowing Fund instead of
the Conduit. HSBC Securities states that these arrangements provide
additional assurances to the holders of Promissory Notes that the
Promissory Notes will be paid at maturity.
    6. A Conduit purchases receivables and other assets from, and makes
secured loans to, a broad range of sellers and borrowers in a variety
of industries. Aggregate loans made by a Conduit to Borrowing Funds are
not expected to be more than 20%, and usually would be considerably
less than 20%, of the Conduit's outstanding loans and other assets.
    7. HSBC Securities represents that the revolving credit and
security agreement of a Loan Facility, which will be negotiated by the
parties, will contain representations, warranties, covenants

and events of default that are customary for secured loan transactions
involving open-end investment companies as well as such other terms
that are specific to a particular Borrowing Fund and the conduct of its
business. A Borrowing Fund will have the right to prepay its loans and
terminate its participation in a Loan Facility upon prior notice at any
time. The Pledged Assets of a Borrowing Fund will be available solely
to secure repayment of the loans and other outstanding obligations of
that Borrowing Fund under a Loan Facility. HSBC Securities further
states that a Borrowing Fund would have the same rights and remedies
under state and federal law with respect to a loan from a Conduit that
it would have with respect to a comparable loan from a bank. HSBC
Securities also states that the arrangements with the Liquidity
Providers protect Borrowing Funds by providing an alternative source of
financing in the event a Conduit is unable to continue lending funds.
    8. No Borrowing Fund will participate in a Loan Facility unless it
has represented, in writing, to HSBC Securities, the Conduit and the
Liquidity Providers that: (a) Its policies permit borrowing and, if
applicable, the use of leverage; (b) all borrowing transactions
pursuant to the Loan Facility will be subject to the requirements of
the Act, the rules and regulations thereunder, and any other applicable
interpretations or guidance from the Commission or its staff; and (c)
each borrowing transaction will be conducted in accordance with all
applicable representations and conditions of the application. Before a
Borrowing Fund may participate in a Loan Facility, the Borrowing Fund's
board of directors or trustees (``Board''), including a majority of the
directors or trustees that are not ``interested persons'' within the
meaning of section 2(a)(19) of the Act (``Disinterested Directors''),
will determine that such participation is consistent with the Borrowing
Fund's investment objectives and policies and in the best interests of
the Borrowing Fund and its shareholders. Each Borrowing Fund's Board,
including a majority of the Disinterested Directors, will also adopt
procedures for evaluating and making certain determinations concerning
the terms of each loan transaction between the Borrowing Fund and a
Conduit.
    9. HSBC Securities states that the proposed Loan Facilities would
enable Borrowing Funds to borrow money from the Conduits at lower cost
than obtaining comparable loans from a bank. HSBC Securities states
that a Conduit's cost of funds is lower than that of banks, and this
advantage will be passed on to the Borrowing Funds.\1\
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    \1\ The rate at which a Liquidity Provider would make a loan to
a Borrowing Fund would not be as favorable as that of the Conduit,
but would be comparable to the rates on secured lines of credit from
banks. HSBC Securities anticipates that a Conduit, rather than a
Liquidity Provider, will be the lender to the Borrowing Funds under
a Loan Facility, absent extenuating circumstances.
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Applicant's Legal Analysis

    1. Section 18(f)(1) of the Act prohibits an open-end investment
company from issuing any senior security except that a company is
permitted to borrow from any bank, if immediately after the borrowing,
there is an asset coverage of at least 300% for all borrowings of the
company.\2\ Section 2(a)(5) defines ``bank'' as a depository
institution, a branch or agency of a foreign bank, a member bank of the
Federal Reserve System, a banking institution or other trust company
that, as a substantial portion of its business, receives deposits or
exercises fiduciary powers similar to those permitted to national
banks, or a receiver, conservator or liquidating agent of any of the
foregoing. Applicant states that while a Conduit engages in many of the
same business activities as banks, it is not a ``bank'' under this
definition.
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    \2\ Under section 18(g) of the Act, the term ``senior security''
includes any bond, debenture, note, or similar obligation or
instrument constituting a security and evidencing indebtedness.
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    2. Section 6(c) of the Act permits the Commission to exempt any
person or transaction or any class or classes of persons or
transactions from any provision or provisions of the Act, if and to the
extent that such exemption is necessary or appropriate in the public
interest and consistent with the protection of investors and the
purposes fairly intended by the policy and provisions of the Act. HSBC
Securities requests exemptive relief from section 18(f)(1) solely to
the extent necessary to allow a Borrowing Fund to borrow from a Conduit
that is not a bank. HSBC Securities believes that permitting the
Borrowing Funds to borrow from a Conduit is fully consistent with the
purposes and policies of section 18(f)(1) and would not implicate the
concerns underlying that provision.
    3. HSBC Securities states that section 18(f) of the Act reflects
Congressional concern about excessive borrowing and the issuance of
senior securities by open-end investment companies because these
practices could unduly increase the speculative character and
investment risk of junior securities. HSBC Securities notes that
Borrowing Funds would remain subject to the 300% asset coverage
requirement in section 18(f)(1) of the Act for all borrowings,
including those from a Conduit. HSBC Securities further represents that
Conduit loans will not impose any restrictions on a Borrowing Fund's
shareholders that are different from those imposed by a collateralized
bank loan. Finally, HSBC Securities argues that permitting a Borrowing
Fund to borrow from a Conduit rather than a bank is expected to reduce
its costs of borrowing, which should decrease the risk that a Borrowing
Fund's borrowing costs will exceed the return from securities purchased
with borrowed money and lessen any related incentive to purchase more
speculative portfolio securities to cover those costs.
    4. HSBC Securities states that section 18(f) of the Act also
limited open-end investment companies to borrowing from traditional
institutional lending sources out of a Congressional concern that
public holders of senior securities might be unaware that they were
much riskier instruments than senior securities issued by operating
companies. Senior securities of investment companies typically were
secured by assets that were subject to wide fluctuations in value.
Further, common shareholders could redeem at any time, which also might
affect an open-end investment company's ability to repay its
outstanding debt.
    5. HSBC Securities argues that the Loan Facilities do not involve
the type of senior security holder that section 18(f)(1) of the Act was
designed to protect and that the structure of the Loan Facilities and
related Conduits provide sufficient protection to the parties that face
any risk of loss by lending to an open-end investment company. A
Conduit is or will be administered by HSBC Securities, which has
extensive expertise in administering loans collateralized by financial
instruments that equals or exceeds the expertise of most banks. The
Liquidity Providers are banks as defined by the Act and thus not the
type of senior security holder that Congress believed needed
protection. HSBC Securities states that the Promissory Notes are
general obligations of a Conduit and loans to Borrowing Funds are not
expected to exceed 20% of a Conduit's assets and loans to any
individual Borrowing Fund are not expected to exceed 10% of a Conduit's
assets. Any risk of loss on the Promissory Notes posed by loans to
open-end investment companies is further reduced by HSBC Securities'
expertise, a Conduit's ability to sell the loans to the Liquidity
Providers, and the Conduit-wide liquidity sources.

    6. Applicant states that section 18(f) also reflects a concern that
complex capital structures may permit insiders to manipulate the
allocation of expenses and profits; facilitate control of the
investment company by junior security shareholders with little
investment; and make it difficult for investors in the investment
company to understand what their stock is worth. HSBC Securities states
that borrowing from Conduits would not facilitate pyramiding of control
or manipulative reallocation of expenses and profits. Further, HSBC
Securities believes that borrowings from a conduit would not be any
more difficult for shareholders of a Borrowing Fund to understand than
bank borrowings.
    7. Applicant also states that section 18(f) reflects a concern that
existed when the Act was adopted that borrowings by open-end investment
companies could be used to invest in securities without being subject
to limitations of the Board of Governors of the Federal Reserve System
(``FRB'') on the amount of credit that could be used for these purposes
(``margin requirements''). Under Regulations U and T under the
Securities Exchange Act of 1934, in effect prior to enactment of the
Act, only borrowings for such purposes made by a domestic bank or
broker-dealer were subject to margin requirements. HSBC Securities
states that a Conduit would be subject to the same credit restrictions
as a bank under Regulation U as currently in effect.
    8. Finally, Applicant believes the requested relief will benefit
Borrowing Funds by providing them with an alternative, lower-cost
source of financing. For all of these reasons and in light of the
protections afforded by the conditions set forth below, HSBC Securities
believes that permitting Borrowing Funds to borrow from the Conduits
would be in the best interests of the Borrowing Funds and their
shareholders, appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act.

Applicant's Conditions

    The Applicant agrees that any order granting the requested relief
will be subject to the following conditions:
    1. All Borrowing Funds will comply with the asset coverage
requirements in section 18(f)(1) of the Act, including with respect to
all borrowings from a Conduit.
    2. A loan by a Conduit to a Borrowing Fund will be at an interest
rate equal to the Conduit's cost of funds (i.e., the weighted average
Promissory Note rate plus dealer commissions).
    3. Before a Borrowing Fund may participate in a Loan Facility, the
Borrowing Fund's Board, including a majority of the Disinterested
Directors, will determine that participation in the Loan Facility is
consistent with the Borrowing Fund's investment objectives and policies
and is in the best interests of the Borrowing Fund and its
shareholders. In addition, a Borrowing Fund will disclose in its
statement of additional information all material facts about its
participation in the Loan Facility.
    4. Before a Borrowing Fund may participate in a Loan Facility, its
Board, including a majority of the Disinterested Directors, will adopt
procedures governing the Borrowing Fund's participation in the Loan
Facility (``Procedures''). In addition to any other provisions the
Board may find necessary or appropriate to be included in the
Procedures, the Procedures will require that, before a Borrowing Fund
may enter into loan transactions with a Conduit, the Board, including a
majority of the Disinterested Directors, will determine that:
    a. The borrowing is in the best interests of the Borrowing Fund and
its shareholders;
    b. the borrowing and pledge of assets are consistent with the
Borrowing Fund's investment objectives and policies;
    c. the total anticipated cost of the Loan Facility (including fees
and interest) does not exceed the total anticipated costs of comparable
financing alternatives that are available to the Borrowing Fund;
    d. the Borrowing Fund's asset eligibility criteria are consistent
with its investment objectives and policies; and
    e. each Borrowing Fund's investments, consistent with the
eligibility criteria and any other requirements of participating in the
Loan Facility, will be in the best interests of the Borrowing Fund and
its shareholders.
    5. If a Conduit determines (a) to require the Liquidity Providers
to acquire from the Conduit outstanding loans made to a Borrowing Fund,
or (b) not to extend additional loans to a Borrowing Fund, the Board of
the Borrowing Fund, including a majority of the Disinterested
Directors, will be notified promptly. As soon as practicable, the
Board, including a majority of the Disinterested Directors, must
determine whether it is in the best interests of the Borrowing Fund and
its shareholders to continue to participate in the Loan Facility or to
terminate the Borrowing Fund's participation in the Loan Facility in
accordance with its terms.
    6. At each regular quarterly meeting, the Board, including a
majority of the Disinterested Directors, will (a) review a Borrowing
Fund's loan transactions under a Loan Facility during the preceding
quarter, including the terms of each transaction; and (b) determine
whether the transactions were effected in compliance with the
Procedures and the terms and conditions of the order. At least
annually, the Board, including a majority of the Disinterested
Directors, will (a) with respect to a Borrowing Fund's continued
participation in a Loan Facility, make the determinations required in
condition 3 above and (b) approve such changes to the Procedures as it
deems necessary or appropriate.
    7. A Borrowing Fund will maintain and preserve permanently in an
easily accessible place a written copy of the Procedures and any
modifications to the Procedures. The Borrowing Fund will maintain and
preserve for a period of not less than six years from the end of the
fiscal year in which any transaction with a Loan Facility occurred, the
first two years in an easily accessible place, a written record of each
transaction setting forth a description of the terms of the
transaction, including the amount, the maturity, and the rate of
interest on the loan and all information upon which the determinations
required by these conditions were made.
    8. The Applicant will not enter into a Loan Facility with any
Borrowing Fund if, at the time of such transaction, the Applicant, the
Conduit or any Liquidity Provider is an affiliated person of a
Borrowing Fund, within the meaning of section 2(a)(3) of the Act, or an
affiliated person of an affiliated person of a Borrowing Fund.

    For the Commission, by the Division of Investment Management,
under delegated authority.
 Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-8364 Filed 5-1-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3306-3313]
[FR Doc No: 2022-01139]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0049]

Revocation of Five Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection and/or Diagnosis of COVID-19;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorizations (EUAs) (the

Authorizations) issued to Cellex Inc. for the Cellex q-SARS-CoV-2 IgG/
IgM Rapid Test, BioM[eacute]rieux SA for the SARS-COV-2 R-GENE, Siemens
Healthcare Diagnostics Inc. for the Atellica IM SARS-CoV-2 IgG (COV2G),
Siemens Healthcare Diagnostics Inc. for the ADVIA Centaur SARS-CoV-2
IgG (COV2G), and Cepheid for the Xpert Omni SARS-CoV-2. FDA revoked
these Authorizations under the Federal Food, Drug, and Cosmetic Act
(FD&C Act). The revocations, which include an explanation of the
reasons for each revocation, are reprinted in this document.

DATES: The Authorization for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test
is revoked as of December 10, 2021. The Authorizations for the SARS-
COV-2 R-GENE, Atellica IM SARS-CoV-2 IgG (COV2G), and ADVIA Centaur
SARS-CoV-2 IgG (COV2G) are revoked as of December 17, 2021. The
Authorization for the Xpert Omni SARS-CoV-2 is revoked as of December
20, 2021.

ADDRESSES: Submit written requests for a single copy of the revocations
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocations may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. On April 1, 2020, FDA issued an
EUA to Cellex Inc. for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test,
subject to the terms of the Authorization. Notice of the issuance of
this Authorization was published in the Federal Register on June 5,
2020 (85 FR 34638), as required by section 564(h)(1) of the FD&C Act.
On May 6, 2020, FDA issued an EUA to BioM[eacute]rieux SA for the SARS-
COV-2 R-GENE, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
July 14, 2020 (85 FR 42407), as required by section 564(h)(1) of the
FD&C Act. On July 31, 2020, FDA issued an EUA to Siemens Healthcare
Diagnostics Inc. for the Atellica IM SARS-CoV-2 IgG (COV2G), subject to
the terms of the Authorization. Notice of the issuance of this
Authorization was published in the Federal Register on November 20,
2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C Act.
On July 31, 2020, FDA issued an EUA to Siemens Healthcare Diagnostics
Inc. for the ADVIA Centaur SARS-CoV-2 IgG (COV2G), subject to the terms
of the Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on November 20, 2020 (85 FR 74346),
as required by section 564(h)(1) of the FD&C Act. On November 27, 2020,
FDA issued an EUA to Cepheid for the Xpert Omni SARS-CoV-2, subject to
the terms of the Authorization. Notice of the issuance of this
Authorization was published in the Federal Register on April 23, 2021
(86 FR 21749), as required by section 564(h)(1) of the FD&C Act.
Subsequent updates to the Authorizations were made available on FDA's
website. The authorization of a device for emergency use under section
564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act,
be revoked when the criteria under section 564(c) of the FD&C Act for
issuance of such authorization are no longer met (section 564(g)(2)(B)
of the FD&C Act), or other circumstances make such revocation
appropriate to protect the public health or safety (section
564(g)(2)(C) of the FD&C Act).

II. EUA Revocation Requests

    On December 7, 2021, Cellex requested withdrawal of, and on
December 10, 2021, FDA revoked, the Authorization for the Cellex q-
SARS-CoV-2 IgG/IgM Rapid Test. Because Cellex requested that FDA
withdraw the Authorization and FDA understands the product is no longer
being distributed, FDA has determined that it is appropriate to protect
the public health or safety to revoke this Authorization. On December
10, 2021, FDA received a request from BioM[eacute]rieux SA for the
revocation of, and on December 17, 2021, FDA revoked, the Authorization
for the SARS-COV-2 R-GENE. Because BioM[eacute]rieux SA notified FDA
that BioM[eacute]rieux SA has decided to no longer commercially support
the authorized product and requested FDA revoke the Authorization, FDA
has determined that it is appropriate to protect the public health or
safety to revoke this Authorization. On December 9, 2021, FDA received
a request from Siemens Healthcare Diagnostics Inc. for the voluntary
removal of, and on December 17, 2021, FDA revoked, the Authorization
for the Atellica IM SARS-CoV-2 IgG (COV2G). Because Siemens Healthcare
Diagnostics Inc. notified FDA that Siemens Healthcare Diagnostics Inc.
has decided to no longer market the authorized product and requested
FDA voluntarily remove the Atellica IM SARS-CoV-2 IgG (COV2G) from
FDA's list of authorized devices, FDA has determined that it is
appropriate to protect the public health or safety to revoke this
Authorization. On December 9, 2021, FDA received a request from Siemens
Healthcare Diagnostics Inc. for the voluntary removal of, and on
December 17, 2021, FDA revoked, the Authorization for the ADVIA Centaur
SARS-CoV-2 IgG (COV2G). Because Siemens Healthcare Diagnostics Inc.
notified FDA that Siemens Healthcare Diagnostics Inc. has decided to no
longer market the authorized product and requested FDA voluntarily
remove the ADVIA Centaur SARS-CoV-2 IgG (COV2G) from FDA's list of
authorized devices, FDA has determined that it is appropriate to
protect the public health or safety to revoke this Authorization. On
December 17, 2021, FDA received a request from Cepheid for the
revocation of, and on December 20, 2021, FDA revoked, the Authorization
for the Xpert Omni SARS-CoV-2. Because Cepheid has notified FDA that
Cepheid has not commercially distributed any of the Xpert Omni SARS-
CoV-2 product due to the current public clinical needs being met by
Cepheid's other EUA tests that are available and requested FDA revoke
the EUA for the Xpert Omni SARS-CoV-2, FDA has determined that it is
appropriate to protect the public health or safety to revoke this
Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/.

IV. The Revocations

    Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUAs for

Cellex Inc.'s Cellex q-SARS-CoV-2 IgG/IgM Rapid Test, BioM[eacute]rieux
SA's SARS-COV-2 R-GENE, Siemens Healthcare Diagnostics Inc.'s Atellica
IM SARS-CoV-2 IgG (COV2G), Siemens Healthcare Diagnostics Inc.'s ADVIA
Centaur SARS-CoV-2 IgG (COV2G), and Cepheid's Xpert Omni SARS-CoV-2.
The revocations in their entirety follow and provide an explanation of
the reasons for each revocation, as required by section 564(h)(1) of
the FD&C Act.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN21JA22.005

[GRAPHIC] [TIFF OMITTED] TN21JA22.006

[GRAPHIC] [TIFF OMITTED] TN21JA22.007

[GRAPHIC] [TIFF OMITTED] TN21JA22.008

[GRAPHIC] [TIFF OMITTED] TN21JA22.009

    Dated: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01139 Filed 1-20-22; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 78, Number 222 (Monday, November 18, 2013)]
[Notices]
[Pages 69080-69081]
[FR Doc No: 2013-27525]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14546-000]

Houtama Hydropower LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On August 14, 2013, Houtama Hydropower LLC filed an application for
a preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of the McKay Dam
Hydroelectric Project (project) to be located at McKay Dam near
Pendleton in Umatilla County, Oregon. The sole purpose of a preliminary
permit, if issued, is to grant the permit holder priority to file a
license application during the permit term. A preliminary permit does
not authorize the permit holder to perform any land-disturbing
activities or otherwise enter upon lands or waters owned by others
without the owners' express permission.
    The proposed project would utilize flows at the existing McKay
Reservoir, and would consist of the following new features: (1) A 48-
inch diameter, 60-foot-long steel penstock that extends from the
existing dam penstock to a powerhouse; (2) a 20-foot by 30-foot
powerhouse; (3) a single 2.3-megawatt turbine/generator; (4) a
switchyard with a 69 kilovolt (kV) step-up transformer; (5) an
approximately 3,000-foot-long, 69-kV transmission line interconnecting
to the Pacific Power distribution system; and (6) appurtenant
facilities. The estimated annual generation of the project would be 5
gigawatt-hours.
    Applicant Contact: Mr. William C. Hampton, CEO, Houtama Hydropower

LLC, 1044 NW 12th Drive, Pendleton, OR 97801-1268; phone: (541) 969-
2276.
    FERC Contact: Sean O'Neill; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-14546-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14546) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: November 8, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-27525 Filed 11-15-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 25, 2008 (Volume 73, Number 228)]
[Notices]
[Page 71665]
[DOCID:fr25no08-78]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1809-DR]

Missouri; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Missouri (FEMA-1809-DR), dated November 13,
2008, and related determinations.

DATES: Effective Date: November 13, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated November 13, 2008, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford
Act), as follows:

    I have determined that the damage in certain areas of the State
of Missouri resulting from severe storms, flooding, and a tornado
during the period of September 11-24, 2008, is of sufficient
severity and magnitude to warrant a major disaster declaration under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act,
42 U.S.C. 5121-5207 (the Stafford Act). Therefore, I declare that
such a major disaster exists in the State of Missouri.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and Public
Assistance in the designated areas and Hazard Mitigation throughout
the State. Consistent with the requirement that Federal assistance
be supplemental, any Federal funds provided under the Stafford Act
for Hazard Mitigation and Other Needs Assistance will be limited to
75 percent of the total eligible costs. Federal funds provided under
the Stafford Act for Public Assistance also will be limited to 75
percent of the total eligible costs, except for any particular
projects that are eligible for a higher Federal cost-sharing
percentage under the FEMA Public Assistance Pilot Program instituted
pursuant to 6 U.S.C. 777.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Michael L. Karl, of FEMA, is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Missouri have been designated
as adversely affected by this major disaster:

    Boone, Callaway, Chariton, Lewis, Lincoln, Linn, Marion, Osage,
Schuyler, St. Charles, St. Louis, Stone, Taney, Texas, and Webster
Counties and the Independent City of St. Louis, for Individual
Assistance.
    Adair, Audrain, Barry, Bollinger, Butler, Callaway, Cape
Girardeau, Carter, Chariton, Christian, Clark, Crawford, Dent,
Douglas, Dunklin, Howard, Howell, Knox, Lewis, Lincoln, Linn,
Madison, Maries, Marion, Miller, New Madrid, Oregon, Ozark, Perry,
Ralls, Ray, Reynolds, Ripley, Schuyler, Scotland, Scott, Shannon,
Shelby, St. Genevieve, Stoddard, Stone, Sullivan, Taney, Texas,
Wayne, Webster, and Wright Counties, for Public Assistance.
    All counties and the Independent City of St. Louis within the
State of Missouri are eligible to apply for assistance under the
Hazard Mitigation Grant Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-27912 Filed 11-24-08; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register: May 25, 2011 (Volume 76, Number 101)]
[Notices]
[Page 30423-30424]
[DOCID:fr25my11-145]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms, and Record keeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted regarding the Procedures for
Selecting Lines to be Covered by the Theft Prevention Standard below
has been forwarded to the Office of Management and Budget (OMB) for
review and comment. The ICR describes the nature of the information
collections and their expected burden. The Federal Register Notice with
a 60-day comment period was published on February 4, 2011 (76 FR 6512).
The agency received no comments.

DATES: Comments must be submitted on or before June 24, 2011.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725 17th
Street, NW., Washington, DC 20503, Attention NHTSA Desk Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Departments' estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.
    A comment to OMB is most effective if OMB receives it within 30
days of publication.

FOR FURTHER INFORMATION CONTACT: Carlita Ballard at the National
Highway Traffic Safety Administration, Office of International Policy,
Fuel Economy and Consumer Programs (NVS-131), 1200 New Jersey Ave.,
SE., West Building, Room W43-439, NVS-131, Washington, DC 20590. Ms.
Ballard's telephone number is<PHONE_NUMBER>. Please identify the
relevant collection of information by referring to its OMB Control
Number.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: Procedures for Selecting Lines to be Covered by the Theft
Prevention Standard (49 CFR 542).
    OMB Control Number: 2127-0539.
    Type of Request: Extension of a currently approved information
collection.
    Abstract: Manufacturers of light duty trucks must identify new
model introductions that are likely to be high-theft lines as defined
in 49 U.S.C. 33104. In 1984, Congress enacted the Motor Vehicle Theft
Law Enforcement

Act (the 1984 Theft Act). As a means to prevent the theft of motor
vehicles for their parts, the 1984 Theft Act required vehicle
manufacturers to mark the major parts of ``high-theft'' passenger cars
and the major replacement parts for those cars. The Anti Car Theft Act
of 1992 (ACTA) amended the 1984 Theft Act to extend its provisions to
multipurpose passenger vehicles (MPVs) and light duty trucks (LDTs).
    The 1984 Theft Act, as amended by ACTA, requires NHTSA to
promulgate a theft prevention standard for the designation of high-
theft vehicle lines. The specific lines are to be selected by agreement
between the manufacturer and the agency. If there is a disagreement of
the selection, the statute states that the agency shall select such
lines and parts, after notice to the manufacturer and an opportunity
for written comment. NHTSA's procedures for selecting high theft
vehicle lines are contained in 49 CFR part 542.
    In a final rule published on April 6, 2004, the Federal Motor
Vehicle Theft Prevention Standard was extended to include all passenger
cars and multipurpose passenger vehicles with a gross vehicle weight
rating of 6,000 pounds or less, regardless of whether they were likely
to be high or low theft, and to light duty trucks with major parts that
are interchangeable with a majority of the covered major parts of
multipurpose passenger vehicles. The final rule became effective
September 1, 2006.
    NHTSA anticipates that there are approximately 7 vehicle
manufacturers that could request a theft determination. All seven are
still active in the U.S. market and could respond on an annual basis.
We anticipate this to remain the average number of yearly responses
that could be received by the agency.
    NHTSA estimates that the average hours per submittal will be 45,
for a total annual burden of 315. The total annual burden of 315
remains the same as the current OMB inventory. NHTSA estimates that the
cost associated with the burden hours is a $57.06 per hour, for a total
cost of approximately $18,000.
    Affected Public: Motor vehicle manufacturers.
    Estimated Total Annual Burden: NHTSA estimates that there would be
no additional cost to motor vehicle manufacturers that would require it
to comply to this regulation.

Christopher J. Bonanti,
Associate Administrator for Rulemaking.
[FR Doc. 2011-12843 Filed 5-24-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Rules and Regulations]
[Pages 51485-51487]
[FR Doc No: 2014-20537]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2014-0531]
RIN 1625-AA00

Safety Zone, Lower Mississippi River Mile 94.0 to Mile 95.0; New
Orleans, LA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all waters of the Lower Mississippi River from mile marker 94.0 to mile
marker 95.0 above head of passes (AHP). This safety zone is necessary
to protect persons and vessels from potential safety hazards associated
with a barge based fireworks display in the Lower Mississippi River at
mile marker 94.4 AHP. Entry into this zone is prohibited unless
specifically authorized by the Captain of the Port (COTP) New Orleans
or a designated representative.

DATES: This rule is effective from 8:15 p.m. to 9:00 p.m. on September
13, 2014.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2014-0531]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander (LCDR) James Gatz, Sector New
Orleans, at<PHONE_NUMBER> or<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Cheryl
F. Collins, Program Manager, Docket Operations, telephone (202) 366-
9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

AHP Above Head of Passes
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
MM Mile Marker
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this final rule without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that
good cause exists for not publishing a notice of proposed rulemaking
(NPRM) with respect to this rule because it is impracticable and
unnecessary. The Coast Guard received information about this fireworks
display on or about July 25, 2014. As scheduled, the display would take
place before the full NPRM process could be completed. Because of the
dangers presented by an aerial barge based fireworks display taking
place on and over the waterway, it is in the public interest to
establish this safety zone to protect transiting vessels and mariners.
Completing the full NPRM process would delay the establishment of this
safety zone, which is necessary to protect life and property from the
possible dangers and hazards associated with a nighttime waterway based
fireworks display. Delay would also unnecessarily interfere with
possible contractual obligations. While it is in the public's best
interest to provide this safety measure, the impacts on navigation are
expected to be minimal as the safety zone will only be in effect for a
short duration.
    For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard
finds that good cause exists for making this rule

effective less than 30 days after publication in the Federal Register.
Providing a full 30 days notice is contrary to the public interest as
it would delay the effectiveness of the safety zone until after the
planned fireworks event. Immediate action is needed to protect vessels
and mariners from the safety hazards associated with an aerial
fireworks display over a waterway. The Coast Guard will notify the
public and maritime community that the safety zone will be in effect
and of its enforcement periods via broadcast notices to mariners.

B. Basis and Purpose

    Pyrotecnico, a company specializing in fireworks displays, informed
the Coast Guard of a fireworks display sponsored by Malena Badon and
planned for September 13, 2014. The fireworks will be launched from a
barge located at MM 94.4 AHP on the Lower Mississippi River. This
display will take place between 8:15 p.m. and 9:00 p.m. on September
13, 2014 in a high commercial traffic area near a tight river bend.
Therefore, the Coast Guard has determined that a safety zone is needed
to ensure safe navigation for all those in the vicinity of the
fireworks display. This safety zone is established to protect the
public, mariners, and vessels from the hazards associated with a barge
based fireworks display on and over the waterway.
    The legal basis and authorities for this rule are found in 33
U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064;
and Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to establish and define
regulatory safety zones.

C. Discussion of the Final Rule

    The Coast Guard is establishing a temporary safety zone on the
Lower Mississippi River from 8:15 p.m. to 9:00 p.m. on September 13,
2014. The safety zone will include the entire width of the Lower
Mississippi River in New Orleans, LA, from MM 94.0 to MM 95.0 AHP.
Entry into this zone is prohibited unless permission has been granted
by the COTP New Orleans, or a designated representative.
    The COTP New Orleans will inform the public through broadcast
notices to mariners of the enforcement period for the safety zone as
well as any changes in the planned schedule. Mariners and other members
of the public may also contact Coast Guard Sector New Orleans Command
Center to inquire about the status of the safety zone, at (504) 365-
2200.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. This safety zone will
restrict navigation on the Lower Mississippi River from MM 94.0 to MM
95.0 AHP, for approximately forty-five minutes on September 13, 2014.
Due to the limited scope and short duration of the safety zone, the
impacts on routine navigation are expected to be minimal.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. This rule will affect the following entities, some of which may
be small entities: The owners or operators of vessels intending to
transit the Lower Mississippi River from MM 94.0 to MM 95.0 AHP between
8:15 and 9:00 p.m. on September 13, 2014. The Coast Guard certifies
under 5 U.S.C. 605(b) that this rule will not have a significant
economic impact on a substantial number of small entities because it is
limited in scope and will only be in effect for approximately forty-
five minutes on one day. Before enforcement, COTP New Orleans will
issue maritime advisories widely available to users of the river and
will make notifications to the public through marine band radio when
the safety zone is being enforced. Additionally, deviation from this
rule may be requested and will be considered on a case-by-case basis by
COTP New Orleans or a COTP New Orleans designated representative.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of

their discretionary regulatory actions. In particular, the Act
addresses actions that may result in the expenditure by a State, local,
or tribal government, in the aggregate, or by the private sector of
$100,000,000 (adjusted for inflation) or more in any one year. Though
this rule will not result in such an expenditure, we do discuss the
effects of this rule elsewhere in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves establishing a temporary safety zone
for all waters of the Lower Mississippi River from MM 94.0 to MM 95.0
AHP. This rule is categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record-
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04.6, and 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.

0
2. A new temporary Sec.  165.T08-0531 is added to read as follows:

Sec.  165.T08-0531  Safety Zone, Mississippi River Mile 94-Mile 95; New
Orleans, LA.

    (a) Location. The following area is a safety zone: All waters of
the Lower Mississippi River from mile marker 94.0 to mile marker 95.0
above head of passes, New Orleans, LA.
    (b) Effective Date and Enforcement Period. This rule is effective
on September 13, 2014. The safety zone will be enforced from 8:15 p.m.
until 9:00 p.m. on September 13, 2014.
    (c) Regulations.
    (1) In accordance with the general regulations in Sec.  165.23 of
this part, entry into this zone is prohibited unless specifically
authorized by the Captain of the Port (COTP) New Orleans or designated
personnel. Designated personnel include commissioned, warrant and petty
officers of the U.S. Coast Guard assigned to units under the
operational control of USCG Sector New Orleans.
    (2) Vessels requiring deviation from this rule must request
permission from the COTP New Orleans or a COTP New Orleans designated
representative. They may be contacted on VHF-FM Channel 16 or 67, or
through Coast Guard Sector New Orleans at<PHONE_NUMBER>.
    (3) Persons and vessels permitted to deviate from this safety zone
regulation and enter the restricted area must transit at the slowest
safe speed and comply with all lawful directions issued by the COTP New
Orleans or designated representative.
    (d) Information Broadcasts. The COTP New Orleans or a COTP New
Orleans designated representative will inform the public through
broadcast notices to mariners of the enforcement period for the safety
zone as well as any changes in the planned schedule.

    Dated: August 13, 2014.
P. C. Schifflin,
Captain, U.S. Coast Guard, Captain of the Port New Orleans.
[FR Doc. 2014-20537 Filed 8-28-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Page 40633]
[FR Doc No: 2020-14546]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-2249-000]

Priogen Power 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 Priogen Power
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 20, 2020.
    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://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_ADDRESS>or call toll-free, (886) 208-
3676 or TYY,<PHONE_NUMBER>.

    Dated: June 30, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-14546 Filed 7-6-20; 8:45 am]
BILLING CODE 6717-01-P


DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 1 of 20 SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST ( ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection: Certification of Pesticide Applicators OMB No: 2070 0029 EPA No: 0155.07 1( b) Short Characterization/ Abstract This information collection request is designed to provide the Environmental Protection Agency ( EPA) with the authority to administer and oversee training and certification programs for pesticide applicators in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and to enable EPA to collect certain data regarding these programs from States, Indian tribes, and federal agencies ( collectively in this document termed " states" or " entities") with EPAapproved certification plans.

FIFRA allows the EPA to classify a pesticide as " restricted use" if the pesticide meets certain toxicity or risk criteria. Restricted use pesticides, because of their potential to harm human health or the environment, may be applied only by a certified applicator or by a person under the direct supervision of a certified applicator. A person must meet certain standards of competency to become a certified applicator. States can be delegated the certified applicator program, but it must be approved by the Agency before it can be implemented. In non participating entities, EPA administers the certification program.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection Section 3( d) of FIFRA authorizes EPA to classify registered pesticides as either generalor restricted use. Restricted use pesticides ( RUPs) are those that, absent additional regulatory restrictions, may cause unreasonable adverse effects on people or the environment. Pesticides classified as restricted use may only be used by a certified applicator, or by a person under the direct supervision of a certified applicator. A certified applicator is a person who has taken specific training in the safe handling and application of restricted use products, and who has received license ( certification) to that effect. Section 11( a) of FIFRA grants EPA the authority to prescribe standards for the certification of restricted use pesticide applicators. Section 11( a)( 2) of FIFRA establishes a certification program that allows states to implement applicator certification DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 2 of 20 after the state program has been approved by EPA. While the bulk of the certification program is implemented through the States, in non participating States or tribes, EPA has authority to directly administer certification programs. The regulations for the certification program in Title 40 part 171 of the Code of Federal Regulations also include procedures for certification programs for Federal agencies or Indian tribes who wish to develop their own plans in lieu of using State certification programs.

The authority for this information collection activity is provided under sections 3( d) and 11 of FIFRA and 40 CFR part 171.

2( b) Practical Utility/ Users of the Data The annual reports from the states are used as a monitoring tool to develop overall data on pesticide activities for OMB, Congress, and others; to distribute EPA grant funds to participating states, to target enforcement activities, and to revise certification and training program emphasis and requirements.

An application form is used to obtain vital information from applicants such as name and address, and to schedule applicators for certification or re certification.

Dealer records are necessary for EPA to ensure that access to restricted use pesticides is limited to certified applicators. State administered certification programs use State authority to require dealers to maintain records of restricted use pesticide sales.

Application records are required by EPA under federally run programs ( currently the Navajo Indian Country program) for certified commercial applicators. EPA monitors these records to assure that restricted use pesticides are used only by, or under the supervision of, certified applicators and to ensure that pesticide labeling requirements are adhered to by requiring applicators to record details of the restricted use product application. Without these records it would often be difficult to successfully enforce against misuse.

Application records are also required for certified commercial applicators under state run programs. These records are monitored to assure that restricted use pesticides are used only by, or under the supervision of, properly trained and certified applicators and to ensure that pesticide labeling requirements are adhered to by requiring the applicators to record the application ( amounts, locations, and dates) of restricted use pesticides. Without these records it would often be difficult to successfully enforce against misuse and ensure proper training and supervision of uncertified applicators. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 3 of 20 3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non duplication EPA is the only Federal agency with the authority to certify applicators of restricted use products. However, the United States Department of Agriculture ( USDA) also has regulations which impact certified applicators. In addition to providing most of the training for certified applicators under an Interagency Agreement ( IAG) with EPA, USDA has regulations which require private and commercial applicators to maintain detailed records regarding the application of restricted use pesticides. The records required by USDA under 7 CFR 110 are much more detailed than those required by EPA under 40 CFR 171.

FIFRA prohibits EPA from requiring private applicators to keep records or make reports, so there is no duplication with regard to private applicators. In addition, although both USDA and EPA appear to impose record keeping requirements on commercial applicators, EPA's requirements are only a subset of USDA's requirements and consist mostly of information that is already maintained by commercial applicators as part of their ordinary and customary business practices. As such there is no contradiction or practical duplication.

To prevent duplication and facilitate State reporting, EPA permits States to use grant reports in lieu of the separate annual reports, and States may amend their plan with an addendum.

3( b) Public Notice Required Prior to ICR Submission to OMB Pursuant to 5 CFR 1320.8( d), EPA will publish a Federal Register notice soliciting comments on this information collection activity and EPA's intent to renew the OMB approval of this ICR. Comments received will be considered in the preparation of the final ICR renewal.

3( c) Consultations The regulations under 40 Code of Federal Regulations, Part 171 ( 40 CFR 171) were published in the Federal Register in 1974, 1975 and 1978 with minor modifications in 1983 and 1984. All sections of the regulations provided a comment period for interested parties prior to promulgation. The comments received were evaluated by the Agency prior to issuance of the final rule. Continuous consultation and/ or dialogue between industry and the Agency occurs on an informal, on going, " as needed" basis, primarily during the submission and review of reports. The certified applicator base has become stable over the years.

In addition, during preparation of this ICR renewal, EPA staff will contact representatives from a cross section of respondents by e mail and telephone to seek feedback on the burden estimates in the ICR, the clarity of instructions provided, the feasibility of reporting the data by DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 4 of 20 electronic means, and other questions pertaining to the requirements of the program.

3( d) Effects of Less Frequent Collection Only annual reports from participating States are submitted to EPA on a routine basis. Annually is considered a minimal reporting period. As described earlier, most annual reporting information required under the regulation is contained in the annual grant report, and can be submitted as a joint package. In the future, states will be able to provide their annual reports electronically via the C& T Template. Budget requests and the distribution of cooperative agreement funds are done on an annual basis. The annual report data is used to support budget requests and to apportion cooperative agreement funds. Less frequent collection of information would not allow the Agency to distribute these funds in the most equitable manner, as data demonstrating need would not be accurate.

3( e) General Guidelines Pursuant to 5 CFR 1320.6, the Agency seeks OMB approval of EPA Form 8500 17 for use whenever the Agency administers the Certified Pesticide Applicator program in the place of a State administered program. The Agency's use of such a form under these circumstances is required by FIFRA section 11( a)( 1). This information collection activity does not exceed any other of the Paperwork Reduction Act guidelines contained at 5 CFR 1320.6.

3( f) Confidentiality The activities or records proposed in this regulation will not involve any confidentiality concerns or information.

3( g) Sensitive Questions The activities proposed in this regulation will not involve any sensitive questions.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ NAICS codes The North American Industrial Classification System ( NAICS) code for respondents participating in the data collection activity are noted here: DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 5 of 20 Farms:

11 Crop Production 112 Animal Production Commercial Services:

561710 Exterminating and Pest Control Services Administration of Certification Programs by States/ Tribal Lead Agencies:

924110 Environmental protection program administration 926140 Pest control programs, agricultural, governmental Pesticide Dealers ( only for EPA administered programs)

444220 Retail Nursery, Lawn, and Garden Supply stores 424910 Agricultural chemicals merchant wholesalers 4( b) Information Requested i. Data items, including recordkeeping requirements A. Annual Reports Annual reports are required from States, Indian tribes, and Federal agencies with EPA approved certification plans. These entities are required to develop reports based on the requirements in the regulations, including information on their respective program activity, such as the number of applicators certified and any significant changes to their plans.

B. Application for certification in EPA administered programs ( Colorado and Navajo Indian Country)

Currently, EPA administers the private applicator certification program in one state, Colorado. The regulations require, in EPA administered programs, an application form be completed for persons seeking certification or re certification. The forms are necessary for EPA to schedule certification and re certification, and to obtain vital information such as name and address.

EPA is implementing a certified applicator program in the Navajo Indian Country. Both commercial and private applicators will be covered by this program, and a form to apply will DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 6 of 20 be required. Applicators with current certification from New Mexico, Utah, and Arizona will be eligible for certification in the Navajo Indian Country with proof of certification and a completed form. There are currently 40 applicators that will need certification in Navajo Indian Country, and we expect that all will apply in the first year of the program.

The regulations do not require States to use the EPA's application form, they may use similar forms developed to meet their specific needs. A copy of EPA's application form for requesting certification is attached.

C. Dealer record keeping in EPA administered programs ( Colorado and Navajo Indian Country)

The regulations require dealers under EPA administered programs to keep records of the sale of restricted use products for 24 months. Dealer records are maintained at the pesticide dealership, and are not routinely submitted to EPA; however they may be collected as part of an investigation or enforcement action. This is necessary for EPA to ensure that access to restricted use pesticides is limited to certified applicators, or those under their supervision. Without the ability to limit access to restricted use pesticides, there would be little purpose in certifying workers or classifying pesticides for restricted use. This provision is solely intended to provide EPA with the authority to impose dealer record keeping in entities with EPA administered programs. State administered programs must use State authority to require dealers to maintain records of restricted use pesticide sales.

In Colorado, dealers of pesticide products are required to create and maintain records; however, there are currently no pesticide dealers in Navajo Indian Country.

D. Commercial Applicator Records  EPA managed programs Commercial applicators under EPA administered programs must keep records on the kinds, amounts, uses, dates and places of restricted use pesticide applications immediately after the application is complete. Records must be retained for two years. Records are not required to be submitted, but they must be made available to EPA or State officials upon request. Records collected may become part of an enforcement action or investigation.

E. Commercial Applicator Records  State managed programs Commercial applicators under State administered programs must keep records on the kinds, amounts, uses, dates and places of restricted use pesticide applications immediately after the application is complete. Records must be retained for two years. Records are not required to be submitted, but they must be made available to EPA or State officials upon request. Records collected may become part of an enforcement action or investigation. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 7 of 20 ii. Respondent Activities A typical respondent will perform the following activities:

Read rules or other instructions Read applicable regulations, 40 CFR 171, grant requirements, and other applicable requirements Receive Training Administered by EPA approved program or EPA Create information Document activities/ applications Gather information Collect records needed to develop annual report Review Review information for accuracy Complete written forms or other instruments Extract data from records and compile into reporting format Record, disclose, display, or report the information Compile report and submit. Record maintenance for preparation of the next annual report, such as grant reports and hard copy and computer records of data required in the annual report.

Store, file, or maintain information. Store and retain records. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 8 of 20 5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities In continuing this collection, EPA will:

Prepare report ( Region 9 for Navajo Indian Country) Region 9 will submit report for this federallyimplemented plan Answer respondent questions Answer respondent questions Review data Review data submissions Record data Record submissions Maintain data Develop/ maintain a master data base for data submissions Reformat data Reformat and distribute data Store data Store data 5( b) Collection Methodology and Management Dealer and commercial applicator records are not routinely collected. Annual reports from EPA approved certified programs are required. The Agency allows respondents to utilize their end of year grant reports to fulfill the annual report requirement under this program to the extent that information contained in such grant reports satisfies Part 171 requirements. Certain minor reporting elements which may be outside the scope of the grant reports may be provided in whatever fashion the respondent finds most convenient and least burdensome. The information required under this program was generally included in the grants reports as a 2 3 page addendum to that report.

The applicator certification form is used as an initial reference point for potential certified applicators in EPA administered programs. The form requires only basic information such as name and address. For EPA administered programs the respective Regions compile and maintain data on program operations. The public may access the data by contacting the appropriate EPA Regional offices. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 9 of 20 5( c) Small Entity Flexibility These regulations apply specifically to individuals who are certified applicators. EPA believes that the records required of certified pesticide applicators and their employees are minimal and would generally be kept for the applicators' own use even in the absence of this regulation. In Colorado and Navajo Indian Country, where EPA administers the certification program, dealers are also required to keep records. EPA does not require the submission of dealer records, but rather requires that the dealer furnish records for inspection and copying upon request.

There are currently no dealers in the Navajo Indian Country.

5( d) Collection Schedule There is not a collection schedule per se. Commercial applicators must generate records on the kinds, amounts, uses, dates, and locations of restricted use pesticide applications immediately after pesticide application, and are required to maintain these records for two years. Although the records are maintained locally and are not required to be submitted to EPA or the State, they must be made available for State or EPA officials upon request. Records collected may become part of an investigation or enforcement action.

6. ESTIMATING THE BURDEN AND COST OF COLLECTION 6( a) Estimating Respondent Burden In estimating the average respondent burden related to the information collection components of the Agency's certification system, the Agency based the burden hour estimates on the Office of Pesticide Programs' extensive experience and knowledge of the Certification and Training Program, Regional contacts and budget staffing records of the Regional offices, and information obtained from USDA, State Agencies, and other resources. The total annual burden for EPA's State, Federal, and Tribal partners to report is estimated to be 4,412 hours, with an average burden of 77.4 hours for each of the 57 participating entities. The average per State burden is based on several estimates that were provided to EPA by participating States.

The total annual burden for certifying applicators where EPA implements the certification program in Colorado for private applicators and for commercial and private applicators in the Navajo Indian Country is estimated to be 517 hours, with an average burden estimate of 0.17 hours per respondent. This burden is based on completing applications. Since the Federal Program is actually managed by Agency personnel, this burden estimate is based on the experience of the personnel running the program in EPA's Region 8. The total annual burden and cost of pesticide DRAFT FOR PUBLIC COMMENT February 10, 2004 1 Source: US Bureau of Labor Statistics, Office of Employment and Unemployment Statistics, ES 202 Program, 1989. Wage Rates of State Government Workers. Non published data. Adjusted for current year with inflation factors.

Page 10 of 20 dealers' record keeping in Colorado is estimated to be an annual burden of 1,330 hours with an average per respondent burden of 5 hours. These estimates were derived from contacts within the State of Colorado, in conjunction with discussions with the EPA Regional office personnel that run the other half of the program in Colorado.

The total annual burden for record keeping by commercial applicators where EPA implements the certification program in the Navajo Indian Country is estimated to be 108.5 hours, with an average burden estimate of 3.1 hours per respondent.

Commercial applicators and firms under state administered programs are also subject to certain record keeping requirements, the information that EPA requires to maintain them under 40 CFR 171. Specifically, EPA requires commercial applicators to record the following information: the name and address of the person for whom the pesticide was applied; the location of the application; the target pest( s); the specific crop or commodity, as appropriate; the name and registration number of the pesticide applied; the amount applied and percent active ingredient per unit of pesticide used; and the type and amount of leftover pesticide disposed of with the method and location of disposal. The Agency estimates that 421,000 commercial applicators will be subject to the record keeping requirements for a total annual respondent burden of 1,305,000 hours. The average per respondent burden is 3.1 hours.

6( b) Estimating Respondent Costs Respondent costs are based on technical, managerial, and clerical burden hours estimated at $ 73, $ 61, and $ 47 per hour, respectively, for states. These labor rates were supplied by the Bureau of Labor Statistics1, and represent loaded labor rates, i. e. salary and overhead costs. There are no managerial or clerical costs associated with this ICR for respondents representing pesticide dealers in Colorado. However, the technical cost for these respondents is estimated at $ 19 per hour. The cost of $ 19 per hour was based on figures given by owners of small retail stores ($ 10 per hour plus 10% overhead plus 15% benefits indexed to 1998 dollars and corrected using inflation factors). The burden hour estimates were derived from knowledge of the Certification and Training Program. This program is run out of EPA Region 8, thus staffing requirements are well known. There are no capital expenditures associated with this information collection activity.

The following tables illustrate the estimated burden and costs associated with the information collection activities of this program. Using the hourly rates mentioned above, the estimated average cost per participating State is $ 4,080, with the total cost for States under this DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 11 of 20 requirement estimated to be $ 232,560. The estimated average cost for certifying private applicators in Colorado and commercial and private applicators in the Navajo Indian Country is $ 3.20 per respondent, with the total cost estimated to be $ 9,728. The total estimated cost for the record keeping requirements of Colorado's pesticide dealers is $ 25,270; averaging $ 95 per response.

The annual respondent cost for commercial applicator record keeping in Navajo Indian Country is estimated at $ 2,065, with an average per respondent cost of $ 59. Commercial applicator programs run under State authority have an estimated cost of nearly $ 25 million, based on 2001 commercial applicator count of 421,000. Again, the per respondent cost is estimated at $ 59. See Tables 4 and 5 for further details. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 12 of 20 Table 1. Annual Respondent Cost/ Burden Estimates for state Annual Reports on Certification and Training Programs Annual Burden Hours TOTALS Collection Activities Tech. $ 61/ hr Clerical $ 47/ hr Hours Cost $

Read/ hear rule or any collective instrument instruction ( incl. compliance determination) 0.25 0 0.25 15 Create information 5 0 5 305 Gather information 5 0 5 305 Process, compile, review info for accuracy 1 0 1 61 Complete written forms or other instruments 0.5 0.5 1 54 Record, disclose, display, or report the information 20 45 65 3335 Store, file, or maintain the information 0 0.1 0.1 5 TOTAL 31.75 45.6 77.35 4080 Annual Burden: Hr Total ( 77.4) x No. of respondents ( 57) = 4,412 hrs Annual Cost: Cost Total ($ 4080) x No. of respondents ( 57) = $ 232,560 DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 13 of 20 Table 2. Annual Respondent Burden Estimates for Certified Applicators in Federal Programs ( Colorado and Navajo Indian Country) for Completion of EPA Application Forms ( private and commercial applicators in Navajo Indian Country; private only in Colorado)

Collection Activities Tech. $ 19/ hr Hours Cost $

Read/ hear rule or any collective instrument instruction ( incl. compliance determination) 0.07 0.07 1.30 Complete written forms or other instruments 0.10 0.10 1.90 TOTAL 0.17 0.17 3.20 Annual Burden: Hr Total ( 0.17) x No. of respondents 3,040 = 517 hrs Annual Cost: Cost Total ($ 3.20) x No. of respondents 3,040 = $ 9728.00 There are approximately 12,000 private applicators in Colorado; they must be re certified every 4 years ( 3,000 recertified annually, on average). In Navajo Indian Country, 35 commercial and 5 private applicators will need to complete application forms to apply for certification.

The cost of $ 19 was based on figures given by owners of small retail stores ($ 10/ hour plus 10% overhead plus 15% benefits indexed to 1998 dollars, with an inflation factor of 1.21). The burden hour estimates were derived from knowledge of the certification and training program. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 14 of 20 Table 3. Annual Respondent Cost/ Burden Estimates for Pesticide Dealers for Record keeping Requirements for Restricted Use Pesticide Certification ( Colorado)

Collection Activities Tech. $ 19/ hr Hours Cost $

Read/ hear rule or any collective instrument instruction ( incl. compliance determination) 0.5 0.5 9.50 Process, compile, review info for accuracy 1 1 19 Complete written forms or other instruments 2.5 2.5 47.50 Record, disclose, display, or report the information 0.5 0.5 9.50 Store, file, or maintain the information 0.5 0.5 9.50 TOTAL 5 5 95 Annual Burden: Hr Total ( 5) x No. of respondents ( 266) = 1,330 hrs Annual Cost: Cost Total ($ 95) x No. of respondents ( 266) = $ 25,270 There are 266 pesticide dealers in Colorado. The cost of $ 19 was based on figures given by owners of small retail stores ($ 10/ hour plus 10% overhead plus 15% benefits indexed to 1998 dollars, with an inflation factor of 1.21). The burden hour estimates were derived from knowledge of the certification and training program. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 15 of 20 Table 4. Annual Respondent Burden Estimates for Commercial Applicators  record keeping in Navajo Indian Country Collection Activities Tech. $ 19/ hr Hours Cost $

Read/ hear rule or any collective instrument instruction ( incl. compliance determination) 0.2 0.2 3.80 Create information 2 2 38 Store, file, or maintain the information 0.9 0.9 17 TOTAL 3.1 3.1 59 Annual Burden: Hr Total ( 3.1) x No. of respondents ( 35) = 109 hrs Annual Cost: Cost Total ($ 59) x No. of respondents ( 35) =$ 2065 The cost of $ 19 was based on figures given by owners of small retail stores ($ 10/ hour plus 10% overhead plus 15% benefits indexed to 1998 dollars, with an inflation factor of 1.21). The burden hour estimates were derived from knowledge of the certification and training program. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 16 of 20 Table 5. Annual Respondent Burden Estimates for Commercial Applicators and Firms for Recordkeeping under State authority Collection Activities Tech. $ 19/ hr Hours Cost $

Read/ hear rule or any collective instrument instruction ( incl. compliance determination) 0.2 0.2 3.80 Create information 2 2 38 Store, file, or maintain the information 0.9 0.9 17 TOTAL 3.1 3.1 59 Annual Burden: Hr Total ( 3.1) x No. of respondents ( 421,000) = 1,305,100 hrs Annual Cost: Cost Total ($ 59) x No. of respondents ( 421,000) =$ 24,839,000 The cost of $ 19 was based on figures given by owners of small retail stores ($ 10/ hour plus 10% overhead plus 15% benefits indexed to 1998 dollars, with an inflation factor of 1.21). The burden hour estimates were derived from knowledge of the certification and training program. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 17 of 20 ( c) Estimating Agency Burden and Cost The Agency normally estimates the annual burden to the federal government to review the submissions. The Agency's total burden associated with the certification of pesticide applicators program is estimated at 1857 hours. The total cost to the Agency is estimated at $ 63,753.

The previous ICR estimated a significantly higher burden, based on proposed changes to the regulations. However, these proposed changes did not take place and the burden calculated here reflects the current process.

Table 6a. Annual Agency Burden/ Cost Estimates  burden to Regional Offices Collection Activities Mgmnt hours ($ 46) Tech. hours ($ 33) Clerical hours ($ 18) Total Hours Cost Prepare Report  Region 9 for Navajo Plan 0 104 0 104 3,432 Answer respondent questions 7.1 228 0 235.1 7,851 Audit/ review submissions 18.8 798 0 816.8 27,199 Record/ enter submissions 0 200 0 200 6,600 Reformat and distribute data 0 91.2 0 91.2 3,009 Store, file, or maintain the information 0 68.4 11.4 79.8 2,462 TOTAL 25.9 1489.6 11.4 1526.9 50,553 The salaries used for management, technical, and clerical were GS 13 step 8, GS 12 step 2, and GS 6 step 4, respectively. These burden hours are estimated based on information provided by four regional offices, and wages are adjusted with an inflation factor. Total hours result in aggregate of 0.72 FTE. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 18 of 20 Table 6b. Annual Agency Burden/ Cost Estimates  Headquarters estimates for Review of submitted reports Collection Activities Tech. Hours @ $ 40/ hr Cost $

Answer respondent questions 100 4,000 Audit/ review submissions 100 4,000 Record/ enter submissions 80 3,200 Reformat and distribute data 40 1,600 Store, file, or maintain the information 10 400 TOTAL 330 13,200 The total Federal burden for the review of the submissions and development of the Navajo Indian Country report is estimated at $ 63,753 and 1857 hours, or approximately 0.9 FTE. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 19 of 20 ( d) Bottom Line Burden Hours and Cost Table Table 7. Bottom Line Burden Hours and Cost Table ( i) Respondent Tally Total Burden Hours Total Cost ($)

States ( Table 1) 4,412 232,560 Federal program  certified applicators ( Tables 2 and 4) 517 109 9,728 2,065 State administered programs  certified applicators 1,305,000 24,839,000 Pesticide Dealers ( Table 3) 1,330 25,270 Bottom Line Respondent total 1,311,368 25,108,623 ( ii) Agency Tally 1,857 63,753 ( e) Reasons for Change in Burden The previous ICR included substantial federal burden for implementing significant changes to the regulation. Those changes were not realized, therefore, the anticipated increases in the federal burden are not included in this ICR.

The public burden compared to the previous ICR has increased slightly, from 1,285,865 to 1,311,368 hours, due to an increase in the number of certified commercial applicators. Burden from programs administered by EPA increased, as the Navajo Indian Country plan for applicators is expected to initiate soon, and the number of applicators certifying is increased in the counts. The cost burden has risen as well, primarily as a result of inflation, from $ 21,456,058 to $ 25,108,623.

( f) Burden Statement The annual burden for this collection is estimated to average 5 hours for pesticide dealer record keeping in Colorado, 0.17 hours for certifying applicators in Colorado and in the Navajo Indian Country, and 77.4 hours for each state to submit annual reports. Certified commercial applicators have an annual average burden of 3.1 hours for preparing and maintaining required records. DRAFT FOR PUBLIC COMMENT February 10, 2004 Page 20 of 20 According to the Paperwork Reduction Act, " burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose, or provide information to or for a Federal agency. For this collection, it is the time reading the regulations, planning the necessary data collection activities, analyzing data, generating reports and completing other required paperwork, and storing, filing, and maintaining the data. The 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. The OMB control number for this information collection appears at the beginning and end of this document. In addition OMB control numbers for EPA's regulations, after initial display in the final rule, are listed in 40 CFR part 9.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OPP 2003 0357, which is available for public viewing at the OPP Docket in the Public Information and Records Integrity Branch, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805.

An electronic version of the public docket for this ICR renewal is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID No. OPP 2003 0357 and OMB Control No. 2070 0029 in any correspondence.