[Federal Register Volume 77, Number 68 (Monday, April 9, 2012)]
[Rules and Regulations]
[Pages 20988-20991]
[FR Doc No: 2012-8391]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2012-0003; Internal Agency Docket No. FEMA-8225]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date.

DATES: The effective date of each community's scheduled suspension is
the third date (``Susp.'') listed in the third column of the following
tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59.

Accordingly, the communities will be suspended on the effective date in
the third column. As of that date, flood insurance will no longer be
available in the community. We recognize that some of these communities
may adopt and submit the required documentation of legally enforceable
floodplain management measures after this rule is published but prior
to the actual suspension date. These communities will not be suspended
and will continue their eligibility for the sale of insurance. A notice
withdrawing the suspension of the communities will be published in the
Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment under 5 U.S.C.
553(b) are impracticable and unnecessary because communities listed in
this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended, 42
U.S.C. 4022, prohibits flood insurance coverage unless an appropriate
public body adopts adequate floodplain management measures with
effective enforcement measures. The communities listed no longer comply
with the statutory requirements, and after the effective date, flood
insurance will no longer be available in the communities unless
remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.
    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

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                                                Effective date
                                                authorization/
                                  Community     cancellation of    Current effective map   Date certain Federal
       State and location            No.         sale of flood             date            assistance no longer
                                                 insurance in                               available in SFHAs
                                                   community
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           Region II

New York:
    Barton, Town of, Tioga            360832  September 2, 1975,  April 17, 2012........  April 17, 2012
     County.                                   Emerg; June 15,
                                               1982, Reg; April
                                               17, 2012, Susp.
    Berkshire, Town of, Tioga         361215  August 8, 1977,     ......do..............   Do.
     County.                                   Emerg; May 15,
                                               1985, Reg; April
                                               17, 2012, Susp.
    Candor, Town of, Tioga            360833  July 30, 1976,      ......do..............   Do.
     County.                                   Emerg; August 19,
                                               1986, Reg; April
                                               17, 2012, Susp.
    Candor, Village of, Tioga         360834  July 21, 1975,      ......do..............   Do.
     County.                                   Emerg; October 1,
                                               1991, Reg; April
                                               17, 2012, Susp.
    Newark Valley, Town of,           360835  June 25, 1973,      ......do..............   Do.
     Tioga County.                             Emerg; February
                                               3, 1982, Reg;
                                               April 17, 2012,
                                               Susp.
    Newark Valley, Village of,        360836  September 2, 1976,  ......do..............   Do.
     Tioga County.                             Emerg; February
                                               3, 1982, Reg;
                                               April 17, 2012,
                                               Susp.
    Nichols, Town of, Tioga           360837  August 6, 1975,     ......do..............   Do.
     County.                                   Emerg; February
                                               17, 1982, Reg;
                                               April 17, 2012,
                                               Susp.
    Nichols, Village of, Tioga        360838  September 2, 1976,  ......do..............   Do.
     County.                                   Emerg; September
                                               29, 1986, Reg;
                                               April 17, 2012,
                                               Susp.
    Owego, Town of, Tioga             360839  December 29, 1972,  ......do..............   Do.
     County.                                   Emerg; June 15,
                                               1977, Reg; April
                                               17, 2012, Susp.
    Owego, Village of, Tioga          360840  December 22, 1972,  ......do..............   Do.
     County.                                   Emerg; May 16,
                                               1977, Reg; April
                                               17, 2012, Susp.
    Richford, Town of, Tioga          361216  August 10, 1976,    ......do..............   Do.
     County.                                   Emerg; May 15,
                                               1985, Reg; April
                                               17, 2012, Susp.
    Spencer, Town of, Tioga           360841  October 16, 1975,   ......do..............   Do.
     County.                                   Emerg; May 15,
                                               1985, Reg; April
                                               17, 2012, Susp.

    Spencer, Village of, Tioga        361471  December 16, 1976,  ......do..............   Do.
     County.                                   Emerg; May 15,
                                               1985, Reg; April
                                               17, 2012, Susp.
    Tioga, Town of, Tioga             360842  August 15, 1975,    ......do..............   Do.
     County.                                   Emerg; May 17,
                                               1982, Reg; April
                                               17, 2012, Susp.
    Waverly, Village of, Tioga        361343  June 27, 1974,      ......do..............   Do.
     County.                                   Emerg; March 16,
                                               1983, Reg; April
                                               17, 2012, Susp.
           Region IV

Georgia:
    East Ellijay, City of,            130089  July 3, 1975,       ......do..............   Do.
     Gilmer County.                            Emerg; November
                                               3, 1999, Reg;
                                               April 17, 2012,
                                               Susp.
    Ellijay, City of, Gilmer          130090  April 22, 1975,     ......do..............   Do.
     County.                                   Emerg; August 15,
                                               1990, Reg; April
                                               17, 2012, Susp.
    Gilmer County,                    130317  October 29, 1982,   ......do..............   Do.
     Unincorporated Areas.                     Emerg; August 15,
                                               1990, Reg; April
                                               17, 2012, Susp.
Tennessee:
    Gallatin, City of, Sumner         470185  May 27, 1975,       ......do..............   Do.
     County.                                   Emerg; August 3,
                                               1981, Reg; April
                                               17, 2012, Susp.
    Goodlettsville, City of,          470287  April 21, 1975,     ......do..............   Do.
     Sumner County.                            Emerg; June 15,
                                               1981, Reg; April
                                               17, 2012, Susp.
    Hendersonville, City of,          470186  May 28, 1974,       ......do..............   Do.
     Sumner County.                            Emerg; November
                                               4, 1981, Reg;
                                               April 17, 2012,
                                               Susp.
    Millersville, City of,            470388  August 30, 1982,    ......do..............   Do.
     Sumner County.                            Emerg; June 15,
                                               1984, Reg; April
                                               17, 2012, Susp.
    Portland, City of, Sumner         470187  February 14, 1975,  ......do..............   Do.
     County.                                   Emerg; August 4,
                                               1987, Reg; April
                                               17, 2012, Susp.
    Sumner County,                    470349  August 5, 1975,     ......do..............   Do.
     Unincorporated Areas.                     Emerg; June 19,
                                               1985, Reg; April
                                               17, 2012, Susp.
    Westmoreland, Town of,            470415  N/A, Emerg; May     ......do..............   Do.
     Sumner County.                            19, 2005, Reg;
                                               April 17, 2012,
                                               Susp.
    White House, City of,             470339  May 13, 1975,       ......do..............   Do.
     Sumner County.                            Emerg; June 1,
                                               1988, Reg; April
                                               17, 2012, Susp.
            Region V
Michigan:
    Grayling, City of, Crawford       260901  May 21, 1992,       ......do..............   Do.
     County.                                   Emerg; June 25,
                                               1992, Reg; April
                                               17, 2012, Susp.
    South Branch, Township of,        261021  May 6, 1998,        ......do..............   Do.
     Crawford County.                          Emerg; N/A, Reg;
                                               April 17, 2012,
                                               Susp.
Minnesota:
    Barnesville, City of, Clay        270078  May 2, 1974,        ......do..............   Do.
     County.                                   Emerg; March 2,
                                               1981, Reg; April
                                               17, 2012, Susp.
    Center City, City of,             270685  September 5, 1975,  ......do..............   Do.
     Chisago County.                           Emerg; January
                                               28, 1983, Reg;
                                               April 17, 2012,
                                               Susp.
    Chisago, City of, Chisago         270707  June 28, 1982,      ......do..............   Do.
     County.                                   Emerg; January 7,
                                               1983, Reg; April
                                               17, 2012, Susp.
    Chisago County,                   270682  September 4, 1975,  ......do..............   Do.
     Unincorporated Areas.                     Emerg; April 18,
                                               1983, Reg; April
                                               17, 2012, Susp.
    Clay County, Unincorporated       275235  August 7, 1970,     ......do..............   Do.
     Areas.                                    Emerg; May 5,
                                               1972, Reg; April
                                               17, 2012, Susp.
    Dilworth, City of, Clay           270080  March 20, 1974,     ......do..............   Do.
     County.                                   Emerg; May 19,
                                               1981, Reg; April
                                               17, 2012, Susp.
    Georgetown, City of, Clay         270082  March 20, 1975,     ......do..............   Do.
     County.                                   Emerg; July 18,
                                               1983, Reg; April
                                               17, 2012, Susp.
    Glyndon, City of, Clay            270083  September 26,       ......do..............   Do.
     County.                                   1975, Emerg;
                                               March 2, 1981,
                                               Reg; April 17,
                                               2012, Susp.
    Hawley, City of, Clay             270084  April 22, 1974,     ......do..............   Do.
     County.                                   Emerg; March 16,
                                               1981, Reg; April
                                               17, 2012, Susp.
    Lindstrom, City of, Chisago       270683  September 4, 1975,  ......do..............   Do.
     County.                                   Emerg; January 7,
                                               1983, Reg; April
                                               17, 2012, Susp.
    Moorhead, City of, Clay           275244  March 19, 1971,     ......do..............   Do.
     County.                                   Emerg; February
                                               18, 1972, Reg;
                                               April 17, 2012,
                                               Susp.
    North Branch, City of,            270072  September 15,       ......do..............   Do.
     Chisago County.                           1987, Emerg; May
                                               19, 1997, Reg;
                                               April 17, 2012,
                                               Susp.
    Stacy, City of, Chisago           270074  October 8, 1975,    ......do..............   Do.
     County.                                   Emerg; July 6,
                                               1984, Reg; April
                                               17, 2012, Susp.
    Wyoming, City of, Chisago         270076  N/A, Emerg; August  ......do..............   Do.
     County.                                   30, 2010, Reg;
                                               April 17, 2012,
                                               Susp.
           Region VI

Arkansas:
    Russellville, City of, Pope       050178  July 17, 1970,      ......do..............   Do.
     County.                                   Emerg; July 18,
                                               1970, Reg; April
                                               17, 2012, Susp.

Oklahoma:
    Bixby, City of, Wagoner           400207  March 6, 1974,      ......do..............   Do.
     County.                                   Emerg; September
                                               28, 1979, Reg;
                                               April 17, 2012,
                                               Susp.
    Broken Arrow, City of,            400236  November 27, 1974,  ......do..............   Do.
     Wagoner County.                           Emerg; August 17,
                                               1981, Reg; April
                                               17, 2012, Susp.
    Catoosa, City of, Wagoner         400185  January 8, 1976,    ......do..............   Do.
     County.                                   Emerg; August 1,
                                               1980, Reg; April
                                               17, 2012, Susp.
    Coweta, City of, Wagoner          400216  March 21, 1978,     ......do..............   Do.
     County.                                   Emerg; September
                                               18, 1986, Reg;
                                               April 17, 2012,
                                               Susp.
    Okay, Town of, Wagoner            400217  July 8, 1977,       ......do..............   Do.
     County.                                   Emerg; September
                                               28, 1982, Reg;
                                               April 17, 2012,
                                               Susp.
    Porter, Town of, Wagoner          400434  September 28,       ......do..............   Do.
     County.                                   1977, Emerg;
                                               January 26, 1983,
                                               Reg; April 17,
                                               2012, Susp.
    Red Bird, Town of, Wagoner        400321  October 21, 1976,   ......do..............   Do.
     County.                                   Emerg; October 9,
                                               1979, Reg; April
                                               17, 2012, Susp.
    Tulsa, City of, Wagoner           405381  November 20, 1970,  ......do..............   Do.
     County.                                   Emerg; August 13,
                                               1971, Reg; April
                                               17, 2012, Susp.
    Wagoner, City of, Wagoner         400219  January 14, 1976,   ......do..............   Do.
     County.                                   Emerg; October
                                               19, 1982, Reg;
                                               April 17, 2012,
                                               Susp.
    Wagoner County,                   400215  July 15, 1981,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; December
                                               2, 1988, Reg;
                                               April 17, 2012,
                                               Susp.
Texas:
    Emory, Town of, Rains             480977  September 13,       ......do..............   Do.
     County.                                   2002, Emerg; N/A,
                                               Reg; April 17,
                                               2012, Susp.
    Point, City of, Rains             481156  September 21,       ......do..............   Do.
     County.                                   1981, Emerg;
                                               April 17, 1985,
                                               Reg; April 17,
                                               2012, Susp.
    Rains County,                     480975  January 15, 2003,   ......do..............   Do.
     Unincorporated Areas.                     Emerg; N/A, Reg;
                                               April 17, 2012,
                                               Susp.

          Region VIII

South Dakota:
    Deadwood, City of, Lawrence       460045  November 26, 1974,  ......do..............   Do.
     County.                                   Emerg; February
                                               3, 1982, Reg;
                                               April 17, 2012,
                                               Susp.
    Lawrence County,                  460094  April 30, 1974,     ......do..............   Do.
     Unincorporated Areas.                     Emerg; May 17,
                                               1990, Reg; April
                                               17, 2012, Susp.
    Lead, City of, Lawrence           460190  September 20,       ......do..............   Do.
     County.                                   1999, Emerg; N/A,
                                               Reg; April 17,
                                               2012, Susp.
    Spearfish, City of,               460046  October 30, 1974,   ......do..............   Do.
     Lawrence County.                          Emerg; September
                                               2, 1981, Reg;
                                               April 17, 2012,
                                               Susp.
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*......do =Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: March 27, 2012.
David L. Miller,
Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2012-8391 Filed 4-6-12; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Notices]
[Page 35116]
[FR Doc No: 2021-14081]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4420-DR; Docket ID FEMA-2021-0001]

Nebraska; Amendment No. 15 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster for the
State of Nebraska (FEMA-4420-DR), dated March 21, 2019, and related
determinations.

DATES: This amendment was issued May 27, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated May 27, 2021, the President amended the cost-sharing arrangements
regarding Federal funds provided under the authority of the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
et seq. (the ``Stafford Act''), in a letter to Deanne Criswell,
Administrator, Federal Emergency Management Agency, Department of
Homeland Security, under Executive Order 12148, as follows:

    I have determined that the damage in certain areas of the State
of Nebraska resulting from a severe winter storm, straight-line
winds, and flooding during the period of March 9 to July 14, 2019,
is of sufficient severity and magnitude that special cost sharing
arrangements are warranted regarding Federal funds provided under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act,
42 U.S.C. 5121 et seq. (the ``Stafford Act'').
    Therefore, I amend the declaration of March 21, 2019, to
authorize Federal funds for all categories of Public Assistance at
90 percent of total eligible costs.
    This adjustment to State and local cost sharing applies only to
Public Assistance costs and direct Federal assistance eligible for
such adjustments under the law. The Robert T. Stafford Disaster
Relief and Emergency Assistance Act specifically prohibits a similar
adjustment for funds provided for Other Needs Assistance (Section
408) and the Hazard Mitigation Grant Program (Section 404). These
funds will continue to be reimbursed at 75 percent of total eligible
costs.

(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.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-14081 Filed 6-30-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Notices]
[Pages 14539-14540]
[FR Doc No: 2022-05401]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0968]

Nayade Varona: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring Nayade Varona from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Ms. Varona was
convicted of a felony under Federal law for conduct related to the
development or approval, including the process for development or
approval, of any drug product under the FD&C Act. Ms. Varona was given
notice of the proposed permanent debarment and was given an opportunity
to request a hearing to show why she should not be debarred. As of
December 22, 2021 (30 days after receipt of the notice), Ms. Varona had
not responded. Ms. Varona's failure to respond and request a hearing
within the prescribed timeframe constitutes a waiver of her right to a
hearing concerning this action.

DATES: This order is applicable March 15, 2022.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application if FDA finds that the individual has been convicted of a
felony under Federal law for conduct relating to the development or
approval, including the process of development or approval, of any drug
product under the FD&C Act. On August 11, 2021, Ms. Varona was
convicted as defined in section 306(l)(1) of the FD&C Act in the U.S.
District Court for the Southern District of Florida, Miami Division,
when the court accepted her plea of guilty and entered judgment against
her for one count of Conspiracy to Defraud the United States in
violation of 18 U.S.C. 371.
    The factual basis for this conviction is as follows: As contained
in the Information, entered into the docket on March 16, 2021, and the
Factual Proffer in Support of Ms. Varona's guilty plea, entered into
the docket on June 8, 2021, both from her case, Ms. Varona was employed
as an assistant study coordinator at Tellus Clinical Research (Tellus).
Tellus was a medical clinic that conducted clinical trials on behalf of
pharmaceutical company sponsors. A drug manufacturer (Sponsor)
initiated a clinical trial concerning a new investigational drug
intended to treat patients suffering from irritable bowel syndrome
(Study or IBS Trial). The Sponsor retained a Contract Research
Organization (CRO) to manage various aspects of the IBS Trial. CRO
entered into a contract with Tellus and Martin Valdes, a medical doctor
serving as a clinical investigator for clinical trials conducted at
Tellus and as the clinical investigator for the IBS Trial. The study
protocol for the IBS Trial required subjects to make periodic scheduled
visits to the clinical trial site for which they were paid $100 per
visit. During some of these visits, subjects were required to provide
blood samples for pharmacokinetic analysis, receive physical exams by
clinical trial staff, and undergo electrocardiograms. Subjects were
also required to use an ``e-diary'' system to report their daily
experience with the Study drugs. They would do this by making daily
phone calls to a number maintained by a third party and answering
automated questions nonverbally by touch-tone buttons.
    In her role as an assistant study coordinator, Ms. Varona was
responsible for administering procedures to subjects in the Study and
creating written records reflecting the participation in the Study.
However, Ms. Varona and her co-conspirators engaged in an effort to
impair, impede, and obstruct FDA's legitimate function of regulating
clinical trials of drugs in order to obtain money. Ms. Varona and her
co-conspirators did this by fabricating medical records to portray
persons as legitimate Study subjects when they were not. She and her
co-conspirators falsified these records to make it appear that the
Study subjects had consented to participating in the Study, satisfied
the Study's eligibility criteria, appeared for scheduled visits at the
Study's site, taken Study drugs as required, and received checks as
payment for site visits, among other things. For example, Ms. Varona
represented that she had seen a purported Study subject, spoken to her
about her dietary habits, lifestyle, and exercise regimen, collected a
urine sample, taken vital signs, and dispensed the Study drug to her
when Ms. Varona well knew that the individual was not a Study subject
and that these representations were false. Ms. Varona also knew that
one or more of her co-conspirators placed telephone calls to the e-
diary system for the purposes of reporting fabricated data on behalf of
purportedly legitimate Study subjects.
    As a result of this conviction, FDA sent Ms. Varona by certified
mail on November 8, 2021, a notice proposing to permanently debar her
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(a)(2)(A) of the FD&C Act, that Ms. Varona
was convicted, as set forth in section 306(l)(1) of the FD&C Act, of a
felony under Federal law for conduct relating to the development or
approval, including the process of development or

approval, of any drug product under the FD&C Act. The proposal also
offered Ms. Varona an opportunity to request a hearing, providing her
30 days from the date of receipt of the letter in which to file the
request, and advised her that failure to request a hearing constituted
an election not to use the opportunity for a hearing and a waiver of
any contentions concerning this action. Ms. Varona received the
proposal on November 22, 2021. She did not request a hearing within the
timeframe prescribed by regulation and has, therefore, waived her
opportunity for a hearing and any contentions concerning her debarment
(21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(A) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Ms.
Varona has been convicted of a felony under Federal law for conduct
relating to the development or approval, including the process of
development or approval, of any drug product under the FD&C Act.
    As a result of the foregoing finding, Ms. Varona is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(A) and 306(c)(2)(A)(ii) of the FD&C Act, (21
U.S.C. 355a(2)(A) and 335a(c)(2)(A)(ii))). Any person with an approved
or pending drug product application who knowingly employs or retains as
a consultant or contractor, or otherwise uses the services of Ms.
Varona in any capacity during her debarment, will be subject to civil
money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Ms. Varona provides services in any capacity to a
person with an approved or pending drug product application during her
period of debarment, she will be subject to civil money penalties
(section 307(a)(7) of the FD&C Act). In addition, FDA will not accept
or review any abbreviated new drug application from Ms. Varona during
her period of debarment, other than in connection with an audit under
section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act).
Note that, for purposes of sections 306 and 307 of the FD&C Act, a
``drug product'' is defined as a drug subject to regulation under
section 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, 382) or
under section 351 of the Public Health Service Act (42 U.S.C. 262)
(section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))).
    Any application by Ms. Varona for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2021-N-0968 and sent to the Division of Dockets
Management (see ADDRESSES). The public availability of information in
these submissions is governed by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: March 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05401 Filed 3-14-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 28, 2008 (Volume 73, Number 82)]
[Notices]
[Page 22966-22967]
[DOCID:fr28ap08-68]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

Agency Information Collection Activities: Proposed Collection;
Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 60-day notice and request for comments; revision of a
currently approved collection, OMB No. 1660-0044, FEMA Form 95-56.

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SUMMARY: The Federal Emergency Management Agency (FEMA), as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed continuing information collection. In
accordance with the Paperwork Reduction Act of 1995, this notice seeks
comments concerning the need to conduct a continuous evaluation of
emergency management training programs as it relates to the knowledge
and skills gained by participants through various courses.

SUPPLEMENTARY INFORMATION: Title 44 CFR part 360 implements the
Emergency Management Training Program, designed to increase States'
emergency management capabilities through training of personnel with
responsibilities over preparedness, response, and recovery from all
types of disasters. The Robert T. Stafford Disaster Relief and
Emergency Assistance Act (Pub. L. 93-288) as amended, authorizes
training programs for emergency preparedness for State, local and
tribal government personnel. In response to the Government Performance
and Results Act (GPRA), the information obtained from the Emergency
Management Institute ``Follow-up Evaluation Survey,'' will be a follow-
up tool used to evaluate the knowledge and/or skills participants
obtained at EMI during training courses, and to improve Emergency
Management Institute courses. The information is critical to determine
if the Emergency Management Institute is meeting strategic goals and
objectives established by FEMA in order to fulfill its mission.

Collection of Information

    Title: Emergency Management Institute Follow-up Evaluation Survey.
    Type of Information Collection: Revision of a currently approved
collection.
    OMB Number: 1660-0044.
    Form Numbers: FEMA Form 95-56, Follow-Up Evaluation Survey.
    Abstract: FEMA Form 95-56 is a continuous self-assessment
qualitative tool used to identify trainees'

knowledge and skills gained through emergency management-related
courses and the extent to which they have been beneficial and
applicable in the conduct of their official positions. The information
collected is primarily used to review course content and offerings for
program planning and management purposes. Results are combined with
other program metrics to document performance per GPRA mandates.
    Affected Public: Individuals or households, State, local or tribal
governments.
    Estimated Total Annual Burden Hours: 950 burden hours.

                                                                   Annual Hour Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual         Total annual
              Data collection activity/instrument                   Number of       Frequency of     Hour burden per   responses (D) =   burden hours (C
                                                                 respondents (A)    responses (B)     response (C)         (A x B)            x D)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FF 95-56......................................................              3800                 1               .25              3800               950
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................              3800               950
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Cost: The estimated annualized cost to respondents based
on wage rate categories is estimated to be $22,344 annually. The
estimated annual cost to the Federal Government is $26,480.
    Comments: Written comments are solicited to (a) evaluate whether
the proposed data collection is necessary for the proper performance of
the agency, including whether the information shall have practical
utility; (b) evaluate the accuracy of the agency's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (c) enhance the
quality, utility, and clarity of the information to be collected; and
(d) minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. Comments must be submitted on or before June
27, 2008.

ADDRESSES: Interested persons should submit written comments to Office
of Management, Records Management Division, Federal Emergency
Management Agency, 500 C Street, SW., Washington, DC 20472, Mail Drop
Room 301, 1800 S. Bell Street, Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: Contact Jennifer Ogle, Training
Specialist, Emergency Management Institute,<PHONE_NUMBER> for
additional information. You may contact the Records Management Branch
for copies of the proposed collection of information at facsimile
number<PHONE_NUMBER> or e-mail address: FEMA-Information-
<EMAIL_ADDRESS>
    Dated: April 21, 2008.
John A. Sharetts-Sullivan,
Director, Records Management Division, Office of Management, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. E8-9238 Filed 4-25-08; 8:45 am]

BILLING CODE 9110-17-P


[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Rules and Regulations]
[Pages 12491-12493]
[FR Doc No: 2012-4667]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2012-0020; FRL-9634-3]

Revisions to the California State Implementation Plan, Antelope
Valley Air Quality Management District and San Joaquin Valley Unified
Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve revisions to the
Antelope Valley Air Quality Management District (AVAQMD) and San
Joaquin Valley Unified Air Pollution Control District (SJVUAPCD)
portions of the California State Implementation Plan (SIP). These
revisions concern negative declarations for volatile organic compound
(VOC) and oxides of sulfur source categories for the AVAQMD and
SJVUAPCD. We are approving these negative declarations under the Clean
Air Act as amended in 1990 (CAA or the Act).

DATES: This rule is effective on April 30, 2012 without further notice,
unless EPA receives adverse comments by April 2, 2012. If we receive
such comments, we will publish a timely withdrawal in the Federal
Register to notify the public that this direct final rule will not take
effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2012-0020, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region
IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Cynthia Allen, EPA Region IX, (415)
947-4120<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What negative declarations did the State submit?
    B. Are there other versions of these negative declarations?
    C. What is the purpose of the submitted negative declarations?
II. EPA's Evaluation and Action.
    A. How is EPA evaluating the negative declarations?
    B. Do the negative declarations meet the evaluation criteria?
    C. Public Comment and Final Action
III. Administrative Requirements

I. The State's Submittal

A. What negative declarations did the State submit?

    Table 1 lists the negative declarations we are approving with the
dates that they were adopted by the AVAQMD and SJVUAPCD and submitted
by the California Air Resources Board (CARB).

                                         Table 1--Negative Declarations
----------------------------------------------------------------------------------------------------------------
                 Local agency                                    Title                    Adopted     Submitted
----------------------------------------------------------------------------------------------------------------
AVAQMD........................................  Petroleum Coke Calcining Operations--      01/18/11     06/20/11
                                                 Oxides of Sulfur.
SJVUAPCD......................................  Synthesized Pharmaceutical Products        04/16/09     06/18/09
                                                 Manufacturing.
SJVUAPCD......................................  Coating Operations at Shipbuilding/        04/16/09     06/18/09
                                                 Ship Repair Facilities.
SJVUAPCD......................................  Manufacture of Pneumatic Rubber Tire..     12/16/10     06/20/11
----------------------------------------------------------------------------------------------------------------

    On December 11, 2009, EPA determined that the SJVUAPCD Negative
Declarations submitted on June 18, 2009, meet the completeness criteria
in 40 CFR Part 51 Appendix V, which must be met before formal EPA
review.
    On December 20, 2011, the submittal for Antelope Valley AQMD and
SJVUAPCD Negative Declarations submitted on June 20, 2011, was deemed
by operation of law to meet the completeness criteria in 40 CFR Part 51
Appendix V, which must be met before formal EPA review.

B. Are there other versions of these negative declarations?

    There are no previous versions of these negative declarations.

C. What is the purpose of the submitted negative declarations?

    For SJVUAPCD, the negative declarations were submitted to meet the
requirements of CAA section 182(b)(2). Nonattainment areas are required
to adopt volatile organic compound (VOC) regulations for the published
Control Techniques Guidelines (CTG) categories. If a nonattainment area
does not have stationary sources covered under a CTG, then the area is
required to submit a negative declaration. The negative declarations
were submitted because there are no applicable sources within the
SJVAPCD jurisdiction.
    For AVAQMD, the negative declaration was submitted to rescind Rule
1119 because there are no sources within the jurisdiction of AVAQMD
subject to the provisions of the rule.
    EPA's technical support document (TSD) has more information about
these negative declarations.

II. EPA's Evaluation and Action

A. How is EPA evaluating the negative declarations?

    The negative declarations are submitted as SIP revisions and must
be consistent with Clean Air Act requirements for Reasonably Available
Control Technology (RACT) (see section 182(b)(2)) and SIP relaxation
(see sections 110(1) and 193.) To do so, the submittal should provide
reasonable assurance that no sources subject to Rule 1119 and the CTG
requirements currently exist or are planned for the AVAQMD and
SJVUAPCD.

B. Do the negative declarations meet the evaluation criteria?

    We believe these negative declarations are consistent with the
relevant policy and guidance regarding RACT and SIP relaxations. The
TSD has more information on our evaluation.

C. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, EPA is fully
approving the submitted negative declarations as additional information
to the SIP because we believe they fulfill all relevant requirements.
We do not think anyone will object to this approval, so we are
finalizing it without proposing it in advance. However, in the Proposed
Rules section of this Federal Register, we are simultaneously proposing
approval of these negative declarations. If we receive adverse comments
by April 2, 2012, we will publish a timely withdrawal in the Federal
Register to notify the public that the direct final approval will not
take effect and we will address the comments in a subsequent final
action based on the proposal. If we do not receive timely adverse
comments, the direct final approval will be effective without further
notice on April 30, 2012.

III. Administrative Requirements

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not interfere with Executive Order 12898 (59 FR 7629
(Feb. 16, 1994)) because EPA lacks the discretionary authority to
address environmental justice in this rulemaking.
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by April 30, 2012. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the Proposed
Rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action may

not be challenged later in proceedings to enforce its requirements (see
section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds, oxides of
sulfur.

    Dated: February 9, 2012.
Jared Blumenfeld,
Regional Administrator, Region IX.
    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52 [AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.222 is amended by adding paragraphs (a)(6)(ix)
    and (a)(8) to read as follows:

Sec.  52.222  Negative declarations.

    (a) * * *
    (6) * * *
    (ix) Petroleum Coke Calcining Operations--Oxides of Sulfur
submitted on June 20, 2011 and adopted on January 18, 2011.
* * * * *
    (8) San Joaquin Valley Unified Air Pollution Control District.
    (i) Synthesized Pharmaceutical Products Manufacturing and Coating
Operations at Shipbuilding/Ship Repair Facilities submitted on June 18,
2009 and adopted on April 16, 2009.
    (ii) Rubber Tire Manufacturing submitted on June 20, 2011 and
adopted on September 20, 2010.
* * * * *

[FR Doc. 2012-4667 Filed 2-29-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 181 (Wednesday, September 20, 2023)]
[Notices]
[Pages 64909-64910]
[FR Doc No: 2023-20380]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0067; FRL-10578-08-OCSPP]

Pesticide Product Registration; Receipt of Applications for New
Uses (August 2023)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received applications to register new uses for
pesticide products containing currently registered active ingredients.
Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), EPA is hereby providing notice of receipt and opportunity to
comment on these applications.

DATES: Comments must be received on or before October 20, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0067, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division
(RD) (7505T), main telephone number:<PHONE_NUMBER>, email address:
[email protected]. The mailing address for each contact person is
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001. As part of the mailing
address, include the contact person's name, division, and mail code.
The division to contact is listed at the end of each application
summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Registration Applications

    EPA has received applications to register new uses for pesticide
products containing currently registered active ingredients. Pursuant
to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
is hereby providing notice of receipt and opportunity to comment on
these applications. Notice of receipt of these applications does not
imply a decision by the Agency on these applications.

Notice of Receipt--New Uses

    File Symbol: 524-AAL. Docket ID number: EPA-HQ-OPP-2023-0379.
Applicant: Bayer CropScience LP, 700 Chesterfield Parkway West,
Chesterfield, MO 63017. Active ingredient: GA20ox_SUP miRNA. Product
type: Plant-incorporated Protectant. Proposed use: Plant Growth
Regulator. Contact: OPP-BPPD-ETB.
    EPA Registration Numbers: 100-739 and 100-1602. Docket ID number:
EPA-HQ-OPP-2023-0395. Applicant: Syngenta Crop Protection, LLC, 410 S
Swing Rd., Greensboro, NC 27409. Active ingredient: Difenoconazole.
Product type: Fungicide. Proposed use: Tobacco. Contact: RD.
    EPA Registration Numbers: 100-1609 and 100-1602. Docket ID number:
EPA-HQ-OPP-2023-0394. Applicant: Syngenta Crop Protection, LLC, 410 S
Swing Rd., Greensboro, NC 27409. Active ingredient: Pydiflumetofen.
Product type: Fungicide. Proposed use: Tobacco. Contact: RD.
    EPA Registration Number: 71512-11. Docket ID number: EPA-HQ-OPP-
2023-0269. Applicant: ISK Biosciences Corporation, 7470 Auburn Road,
Suite A, Concord, Ohio 44077. Active ingredient: Flazasulfuron. Product
type: Herbicide. Proposed use: Avocado. Contact: RD.
    EPA Registration Number: 71512-18. Docket ID number: EPA-HQ-OPP-
2023-0269. Applicant: ISK Biosciences

Corporation, 7470 Auburn Road, Suite A, Concord, Ohio 44077. Active
ingredient: Flazasulfuron. Product type: Herbicide. Proposed use:
Avocado. Contact: RD.
    Authority: 7 U.S.C. 136 et seq.

    Dated: September 14, 2023.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2023-20380 Filed 9-19-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 55 (Wednesday, March 22, 2023)]
[Notices]
[Pages 17289-17291]
[FR Doc No: 2023-05874]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2022-0084]

Advancing High-Speed Rail Projects Intended for Operations Over
160 Miles Per Hour Through Domestic Sourcing Plans and Buy America
Compliance

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice.

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

SUMMARY: The Federal Railroad Administration (FRA) is issuing this
notice to encourage development of high-speed rail (HSR) system
projects intended for operations over 160 miles per hour by
establishing a streamlined process for reviewing domestic sourcing and
workforce plans. Specifically, this notice summarizes FRA's intent to
invite HSR project sponsors to voluntarily submit for review, in
advance of receipt of DOT funding, their domestic sourcing and
workforce plans. This notice provides further clarification to the
December 7, 2022, Notice of Funding Opportunity for the Federal-State
Partnership for Intercity Passenger Rail Program, which stated that FRA
expects all applicants to comply with Buy America requirements without
needing a waiver. However, to obtain a waiver, an applicant must be
prepared to demonstrate how they will maximize the use of domestic
goods, products, and materials in constructing their project.
    If an applicant anticipates it may need a waiver, the applicant
should indicate the need in its application and submit materials
necessary for such requests together with its application. This notice
provides further detail on the recommended content of these materials.
This notice also serves as an RFI to assist with planning a U.S.
domestic content High Speed Rail Industry Exchange Day (Industry Day).

DATES: Applicable on March 22, 2023.

ADDRESSES: Comments should refer to docket number FRA-2022-0084 and be
submitted at https://www.regulations.gov. Search by using

the docket number and follow the instructions for submitting comments.
    Instructions: All submissions must include the agency name and
docket number (FRA-2022-0084) for this Notice and subsequent RFI to
assist with planning a U.S. domestic content High Speed Rail Industry
Exchange Day.
    Note: All comments received, including any personal information,
will be posted without change to the docket and will be accessible to
the public at https://www.regulations.gov. You should not include
information in your comment that you do not want to be made public.
Input submitted online via https://www.regulations.gov is not
immediately posted to the site. It may take several business days
before your submission is posted.

FOR FURTHER INFORMATION CONTACT: For questions about this notice,
please contact Mr. David Valenstein, Office of Railroad Development,
Federal Railroad Administration, 1200 New Jersey Avenue SE, Room W38-
314, Washington, DC 20590; email: [email protected]; 202-493-
6368; Mr. Ryan Arbuckle, Office of Rail Program Development, Federal
Railroad Administration, email: [email protected];<PHONE_NUMBER>;
Mr. John Johnson, Office of Chief Counsel, 1200 New Jersey Avenue SE,
Room W31-208, Washington, DC 20590; email: [email protected]; 202-
384-2421.

SUPPLEMENTARY INFORMATION: FRA is inviting sponsors of high-speed,
steel wheel on steel rail electrically powered passenger railroad
projects intended for operations over 160 miles per hour to voluntarily
submit for review their domestic sourcing and workforce plans
associated with FRA's Buy America requirements \1\ under 49 U.S.C.
22905(a) and section 70914 of the Build America, Buy America Act
included in the Infrastructure Investment and Jobs Act (Pub. L. 117-
58). Project sponsors may begin working with FRA regarding the plans in
connection with applying for federal financial assistance, including
the Federal-State Partnership for Intercity Passenger Rail Program
(FSP-National), Railroad Rehabilitation and Improvement Financing
(RRIF), or other applicable USDOT programs. FRA recognizes that the
domestic manufacturing ecosystem for high-speed rail will require
investment and HSR project sponsors may plan to seek a waiver for
certain goods, products, and materials used in safety- and performance-
critical HSR technology systems (e.g., track, power supply, train
control, rolling stock). Typically, project sponsors wait until after
their project has been selected for award before requesting potential
Buy America waivers. However, the complexity and size of HSR projects
necessitates aligning any waiver and associated implementation plan
with application evaluation processes. In the FSP-National NOFO, FRA
indicated that if an applicant to that program anticipates it may need
a waiver, the applicant should indicate the need in its application and
submit materials necessary for such requests with its application. FRA
has followed a similar approach with certain RRIF applicants such that
Buy America waivers have been considered early in the loan application
process. This notice provides clarification on what materials should be
submitted to support parallel review of a grant application and waiver
request.
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    \1\ Buy America requirements include both FRA Buy America
requirements and Buy America, Build America requirements.
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    FRA's ``Buy America: Answers to Frequently Asked Questions'' (FAQs)
describe FRA's procedures for applying Buy America, including issuing
waivers, to programs such as FSP-National and RRIF (https://railroads.dot.gov/legislation-regulations/buy-america/buy-america-fras-high-speed-intercity-passenger-rail-program). On January 25, 2021,
President Biden signed Executive Order 14005, Ensuring the Future Is
Made in All of America by All of America's Workers, to ensure that
federal financial assistance awards maximize the use of goods,
products, and materials produced in the United States. On April 18,
2022, the Office of Management and Budget issued Initial Implementation
Guidance on Application of Buy America Preference in Federal Financial
Assistance Programs for Infrastructure (M-22-11). This guidance states
that to the greatest extent possible, waivers should be issued at the
project level and be product specific. Also, the guidance encourages
agencies to use the principles of time-limited, targeted, and
conditional for any necessary waivers so that federal financial
assistance drives increasing demand for production of domestically
manufactured goods and products. In accordance with the Build America,
Buy America Act, Executive Order, OMB Guidance, and FRA's FAQs, FRA
will expect potential applicants to FRA- and USDOT-funded financial
assistance programs to:
     Comply with Build America, Buy America Act and FRA Buy
America requirements, including final assembly in the United States and
appropriate domestic content thresholds.
     Maximize the use of domestically produced goods, products,
and materials. Where domestically produced goods, products, and
materials are not currently available in sufficient quantities or of an
acceptable quality to meet demand, applicants are expected to provide
robust evidence of non-availability or unreasonable cost.
     Prepare and implement a domestic sourcing plan for their
HSR projects. The plan should describe how recipients will maximize the
use of available domestic content, or, if such content does not
currently exist, how they will work with suppliers to build production
capacity and the plan should provide justification regarding the use of
the imported goods, products, and materials. If a waiver is needed, the
applicant should describe the associated implementation plan and
expected timeline to reach full FRA Buy America and BABA compliance.
The plan may include--
    [cir] Detail on the extent to which HSR system goods, products, and
materials are not available in the United States; the extent to which
the goods, products, and materials for the HSR project can be sourced
domestically; and the justification for imported items supported by
robust evidence and analysis of industry supply relative to project
demand.
    [cir] An explanation of how the recipient anticipates meeting full
FRA Buy America and BABA compliance.
    [cir] An explanation of how the recipient anticipates using
domestic sources for maintenance and replacement of initially imported
goods and materials used in the project and/or how the recipient will
scale domestic content over time by supporting new or expanded domestic
production of initially imported goods and materials.
    [cir] An explanation of how the applicant, and, if applicable, its
domestic suppliers, plan to support the creation of high-quality
American jobs consistent with Good Jobs Principles. The Department
intends to use the HSR program to support the creation of good-paying
jobs with the free and fair choice to join a union and the
incorporation of strong labor standards and training and placement
programs consistent with Executive Order 14025, Worker Organizing and
Empowerment (86 FR 22829), and Executive Order 14052, Implementation of
the Infrastructure Investment and Jobs Act (86 FR 64335). These
provisions will be considered in conjunction with domestic sourcing
plans so that, when taken together, the domestic sourcing and workforce
plans present a commitment to create high-quality jobs for the
communities in which the project will operate.

    FRA acknowledges that domestic sourcing plans may contain material
the submitter considers to be confidential commercial information or
trade secrets (collectively, CCI), and not customarily released to the
public. Project sponsors should indicate as such domestic sourcing
plans they consider to be CCI and not customarily released to the
public, and request that the information be protected from release. To
the extent permitted by law, FRA will not release such information. FRA
will handle subsequent Freedom of Information Act, 5 U.S.C. 552,
requests for the information according to the regulatory process
described at 49 CFR part 7.

Industry Day

    High speed rail manufacturing, assembly, installation, and
maintenance all have the potential to not only support policies on
sustainability and climate, but also to create good-paying, union jobs
in the United States. DOT is interested in hearing from the public,
including stakeholders (such as State and local agencies, the rail
manufacturing industry, component suppliers, labor unions, related
associations, and transportation advocates), to gather information on
manufacturing and assembly processes in the United States for high-
speed rail.

    Issued in Washington, DC.
Amitabha Bose,
Administrator.
[FR Doc. 2023-05874 Filed 3-21-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 151 (Friday, August 5, 2011)]
[Notices]
[Pages 47577-47578]
[FR Doc No: 2011-19941]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13135-002]

City of Watervliet; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On July 1, 2011, the City of Watervliet filed an application for a
successive preliminary permit, pursuant to section 4(f) of the Federal
Power Act (FPA), proposing to study the feasibility of the Delta
Hydroelectric Project to be located at Delta Dam on the Mohawk River in
Oneida County, New York. 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 consist of: (1) The existing 1,016-foot-
long, 76-foot-high Delta Dam, owned by the New York State Canal
Corporation, (2) an existing impoundment having a surface area of 2,700
acres and a storage capacity of 63,200 acre-feet and normal water
surface elevation of 550 feet mean sea level, (3) a proposed powerhouse
containing two generating units with a total installed capacity of 5.0
megawatts, (4) a proposed 17,000-foot-long, 13.2-kilovolt underground
generator lead, and (5) appurtenant facilities. The project would have
an annual generation of 14.1 gigawatt hours.
    Applicant Contact: Mark Gleason, General Manager, City of
Watervliet,

City Hall, Watervliet, NY 12189; phone:<PHONE_NUMBER>.
    FERC Contact: Monir Chowdhury; 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. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site 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>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13135-002) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: August 1, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-19941 Filed 8-4-11; 8:45 am]
BILLING CODE 6717-01-P


Memo to section 316( b) Phase III record Re: downtime unlikely at large manufacturer with multiple intakes Date: August 12, 2004 From: Paul Shriner Contents of original email message For certain compliance technology options, EPA estimates that the intakes may need to be shut down for a period of time. The survey indicates your facility normally operates 24/ 7 365 days per year. Does your facility ever shut down for maintenance activities such that the intake( s) would not be needed for a period of time? If so, how often and for how long? If you had to shut down one or more intakes for a non emergency retrofit lasting days or weeks, how would you do it in order to minimize economic impacts due to lost production? Is the information you provide unique to this facility or is it somewhat representative of other similar facilities? Thank You, John Sunda Science Applications International Corporation 11251 Roger Bacon Drive Reston, VA 20190 Responses Q: Does your facility ever shut down for maintenance activities such that the intake( s) would not be needed for a period of time? A: Our facility is operational 24 hours a day, 7 days a week. Only when maintenance is necessary do we take a portion out of service for a very brief time.

Q: If so, how often and for how long? A: We never completely shut down.

Q: If you had to shut down one or more intakes for a non emergency retrofit lasting days or weeks, how would you do it in order to minimize economic impacts due to lost production? A: Our facility includes approximately 80 facilities and numerous research and development facilities. Our intake structures are equipped with multiple pumps to ensure continuous operation. A retrofit would cause a significant interruption to our facilities. Even though we would not shut down everything at once, it would result in a significant economic loss. We have never shut down everything at once. We would need to engineer a solution to shut down for a retrofit, if it were required. The cost estimate for the engineering and resulting facilities impact would be part of the engineering package. I would not want to guess at the cost without additional engineering studies.

Q: Is the information you provide unique to this facility or is it somewhat representative of other similar facilities? A: I do not believe this is unique to facilities of our size.