[Federal Register Volume 87, Number 95 (Tuesday, May 17, 2022)]
[Notices]
[Pages 29858-29859]
[FR Doc No: 2022-10551]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings in Existing Proceedings

    Docket Numbers: RP22-864-001.
    Applicants: ANR Pipeline Company.
    Description: Tariff Amendment: Cashout Surcharge 2022 Amendment to
be effective 6/1/2022.
    Filed Date: 5/10/22.
    Accession Number: 20220510-5178.
    Comment Date: 5 p.m. ET 5/23/22.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.

Filings Instituting Proceedings

    Docket Numbers: RP22-919-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Castleton
808116 Releases eff 5-10-22 to be effective 5/10/2022.
    Filed Date: 5/10/22.
    Accession Number: 20220510-5167.
    Comment Date: 5 p.m. ET 5/23/22.

    Docket Numbers: RP22-920-000.
    Applicants: Elba Express Company, L.L.C.
    Description: Compliance filing: Annual Cashout True-up 2022 to be
effective N/A.
    Filed Date: 5/11/22.
    Accession Number: 20220511-5026.
    Comment Date: 5 p.m. ET 5/23/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at:http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 11, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-10551 Filed 5-16-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 5, 2009 (Volume 74, Number 42)]
[Notices]
[Page 9606-9607]
[DOCID:fr05mr09-29]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-11-000]

Northern Lights 2009-2010 Zone EF Expansion Project; Notice of
Availability of the Environmental Assessment for the Proposed Northern
Lights 2009-2010 Zone EF Expansion Project

February 27, 2009.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) on the
natural gas pipeline facilities proposed by Northern Natural Gas
Company (Northern) in the above-referenced docket.
    The EA was prepared to satisfy the requirements of the National
Environmental Policy Act. The staff concludes that approval of the
proposed project, with appropriate mitigating measures, would not
constitute a major federal action significantly affecting the quality
of the human environment.
    The EA assesses the potential environmental effects of the
construction and operation of the proposed pipeline facilities
including:
     An approximately 6.37-mile-long extension of the 30-inch-
diameter Faribault-Farmington D-Line in Rice and Dakota Counties,
Minnesota;
     An approximately 6.06-mile-long extension of the 20-inch-
diameter Farmington-North Branch C-Line in Washington County,
Minnesota;
     An approximately 6.04-mile-long extension of the 20-inch-
diameter Elk River loop in Anoka County, Minnesota;
     The replacement of approximately 9.32 miles of the 3- and
2-inch-diameter Rockford Branch Line with 22.95 miles of 16-inch-
diameter pipeline in Carver, Wright, and Hennepin Counties, Minnesota;
     An approximately 11.21 miles of the 16-inch-diameter
greenfield Corcoran Branch Line in Hennepin County, Minnesota;
     A new 15,000 horsepower ISO-rated greenfield compressor
station located near Albert Lea, Minnesota in Freeborn County,
Minnesota; and
     A new meter station in Hennepin County, Minnesota.
    Northern proposes to expand the capacity of its facilities in these
areas to transport an additional 135,000 decatherms per day of natural
gas for incremental firm winter service.
    The EA has been placed in the public files of the FERC. A limited
number of copies of the EA are available for distribution and public
inspection at: Federal Energy Regulatory Commission, Public Reference
Room, 888 First Street, NE., Room 2A, Washington, DC 20426, (202) 502-
8371.
    Copies of the EA have been mailed to federal, state and local
agencies, public interest groups, interested individuals, newspapers,
and parties to this proceeding.
    Any person wishing to comment on the EA may do so. To ensure
consideration prior to a Commission decision on the proposal, it is
important that we receive your comments before the date specified
below.
    Please note that the Commission strongly encourages electronic
filing of any comments or interventions or protests to this proceeding.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site at http://www.ferc.gov under the ``e-Filing'' link and the
link to the User's Guide. Before you can file comments you will need to
create a free account which can be created by clicking on ``Sign-up.''
    If you are filing written comments, please carefully follow these
instructions to ensure that your comments are received in time and
properly recorded:
     Send an original and two copies of your comments to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First St., NE., Room 1A, Washington, DC 20426;

     Label one copy of the comments for the attention of the
Gas Branch 3, PJ11.3.
     Reference Docket No. CP09-11-000; and
     Mail your comments so that they will be received in
Washington, DC on or before March 30, 2009.
    Comments will be considered by the Commission but will not serve to
make the commentor a party to the proceeding. Any person seeking to
become a party to the proceeding must file a motion to intervene
pursuant to Rule 214 of the Commission's Rules of Practice and
Procedures (18 CFR 385.214).\1\ Only intervenors have the right to seek
rehearing of the Commission's decision.
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    \1\ Interventions may also be filed electronically via the
Internet in lieu of paper. See the previous discussion on filing
comments electronically.
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    Affected landowners and parties with environmental concerns may be
granted intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which would not be
adequately represented by any other parties. You do not need intervenor
status to have your comments considered.
    Additional information about the project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC or on the
FERC Internet Web site (http://www.ferc.gov) using the eLibrary link.
Click on the eLibrary link, click on ``General Search'' and enter the
docket number excluding the last three digits in the Docket Number
field. Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-4722 Filed 3-4-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Notices]
[Page 71260]
[FR Doc No: 2021-27063]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2639-028]

Northern States Power Company--Wisconsin; Notice of Application
Tendered for Filing With the Commission and Soliciting Additional Study
Requests and Establishing Procedural Schedule for Relicensing and a
Deadline for Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 2639-028.
    c. Date filed: November 30, 2021.
    d. Applicant: Northern States Power Company--Wisconsin.
    e. Name of Project: Cornell Hydroelectric Project.
    f. Location: On the Lower Chippewa River, in the township of
Cornell, Chippewa County, Wisconsin. The project does not include any
federal lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Matthew Miller, Hydro License Compliance
Consultant, Xcel Energy, 1414 W Hamilton Ave., P.O. Box 8, Eau Claire,
WI 54702; phone:<PHONE_NUMBER>; email: [email protected]
or James Zyduck, Director Hydro Plants, Xcel Energy, 1414 W Hamilton
Ave., P.O. Box 8, Eau Claire, WI 54702.
    i. FERC Contact: Michael Davis<PHONE_NUMBER>,
[email protected].
    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See, 94 FERC ]
61,076 (2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: January 29, 2022.
    The Commission strongly encourages electronic filing. Please file
additional study requests and requests for cooperating agency status
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support
at [email protected],<PHONE_NUMBER> (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-2639-028.
    m. The application is not ready for environmental analysis at this
time.
    n. The Cornell Hydroelectric Project consists of the following
existing facilities: (1) A non-overflow concrete bulkhead with intake;
(2) a powerhouse with an integral intake, four turbine-generator units;
(3) two gated spillways; (4) a concrete non-overflow dam section; (5)
an overflow spillway with flashboards; (5) an earthen embankment; (6) a
step-up transformer; and (7) a transmission line. The project has a
storage capacity of 7,005 acre-feet at reservoir elevation of 1000.6
feet National Geodetic Vertical Datum with a surface area of about 897
acres. The project has a combined total rated capacity of 30.75
megawatts.
    o. A copy of the application may be viewed on the Commission's
website at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access the document. At this time, the Commission has
suspended access to the Commission's Public Reference Room, due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19), issued by the President on March 13,
2020. For assistance, contact FERC Online Support.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    p. Procedural schedule and final amendments: The application will
be processed according to the following preliminary schedule. Revisions
to the schedule will be made as appropriate.

Issue Deficiency Letter (if necessary) January 2022
Request Additional Information (if necessary) January 2022
Issue Scoping Document 1 for comments June 2022
Issue Scoping Document 2 (if necessary) October 2022
Issue Notice of Ready for Environmental Analysis October 2022

    Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: December 8, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-27063 Filed 12-14-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 232 (Monday, December 3, 2018)]
[Notices]
[Page 62330]
[FR Doc No: 2018-26133]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4393-DR; Docket ID FEMA-2018-0001]

North Carolina; Amendment No. 10 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 declaration
for the State of North Carolina (FEMA-4393-DR), dated September 14,
2018, and related determinations.

DATES: This amendment was issued November 15, 2018.

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: The notice of a major disaster declaration
for the State of North Carolina is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of September 14, 2018.

    Guilford County for Public Assistance, including direct federal
assistance (already designated for Individual Assistance).
    McDowell County for Public Assistance, including direct federal
assistance.

    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.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-26133 Filed 11-30-18; 8:45 am]
 BILLING CODE 9111-11-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER
EPA Registration Division contact: Shaja Joyner, Registration Support Branch
(703) 308-3194
INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.
TEMPLATE:
Nichino America, Inc.
4550 New Linden Hill Rd., Suite 501
Wilmington, DE 19808

Pesticide Petition xxxxxx
	EPA has received a pesticide petition (PP xxxxxx) from Nichino America, Inc., 4550 New Linden Hill Rd., Suite 501, Wilmington, DE 19808, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.484 by establishing a tolerance for residues of flutolanil [N-(3-(1-methylethoxy) phenyl) -2- (trifluoromethyl) benzamide] and its metabolite, M-4, desisopropylflutolanil [N-(3-hydroxyphenyl)-2-(trifluromethyl) benzamide], expressed as 2-trifluoromethyl benzoic acid and calculated as flutolanil in or on the raw agricultural commodities cotton, seed and soybean, seed at 0.05 parts per million (ppm).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.
A. Residue Chemistry
   1. Plant metabolism.  The metabolism of flutolanil in plants is adequately understood for the purposes of the petition.  Plant metabolism studies have been conducted in rice, cucumber, and peanuts.  The metabolic profile for flutolanil was similar in all three crops.  The major route of degradation was 4-0-dealkylation to desisopropylflutolanil, followed by conjugation.  Other metabolites may occur at very low levels due to hydroxylation and oxidation of the side chain, hydroxylation of the aniline ring, and methylation of the hydroxyl groups.  These minor metabolites were also subject to conjugation.  The residues of concern in plants are the parent, flutolanil, and desisopropylflutolanil.
   2. Analytical method.  A previously submitted analytical method designated AU-95R-04 (MRID 45104001), a gas chromatography, mass spectrometry detection method has been independently validated and is adequate for enforcement purposes for flutolanil residue detection in soybean and wheat raw agricultural commodities.  A multi-residue method for flutolanil has been previously submitted.  The method is for use only by experienced chemists who have demonstrated knowledge of the principals of trace organic analysis and have proven skills and abilities to run a complex residue analytical method obtaining accurate results at the part per billion level.  Users of this method are expected to perform additional method validation prior to using the method for either monitoring or enforcement.  The method can detect gross misuse.
   3. Magnitude of residues.  Sugarbeet, cotton and soybean seeds were treated with radiolabled and formulated flutolanil at 1.64 mg a.i./gram seed, 1.22 mg/g and 1.09 mg/g respectively.  The label and target rate was 1.25 mg/g.  Specimens were harvested and total radioactive residues (TRR) were determined for sugarbeet roots and tops, cotton gin trash and seed and soybean forage, hay and seed.  TRR values determined were less than 0.01 ppb for all specimens except treated cotton gin trash (0.013 ppb treated soybean forage (0.075 ppb) and treated soybean hay (0.057 ppb).  Extraction and analysis of soybean forage and hay specimens resulted in no detection of the parent flutolanil and a metabolite profile where no single metabolite exceeded 0.035 ppm.  For cotton gin trash, very low residue of flutolanil was detected (0.001 ppm) and a metabolite profile where no single metabolite exceeded 0.004 ppm.
B. Toxicological Profile
   An extensive battery of toxicology studies has been conducted with flutolanil.  EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk.  The nature of the toxic effects caused by flutolanil is discussed in the document "Flutolanil, Human Health Risk Assessment. Requests for Inadvertent or Indirect Tolerances for use on soybean, wheat, corn and cotton, November 27, 2007" beginning on page 7 in docket ID number EPA-HQ-OPP-2007-1021.
      1.       Acute Toxicity.  [NA-Remove]
      2.       Genotoxicity.   [NA-Remove]
      3.       Reproductive and developmental toxicity.   [NA-Remove]
      4.       Subchronic toxicity.   [NA-Remove]
      5.       Chronic toxicity.  [NA-Remove]
      6.       Animal metabolism.  The metabolism of flutolanil has been extensively studied in various species of mammals. Studies in rats, ruminants and poultry suggest that flutolanil is not well absorbed following oral administration.  Once absorbed, however, it is rapidly metabolized, primarily to desisopropylflutolanil and its conjugates, and rapidly excreted via urine and feces.  The proposed metabolic pathway and corresponding chemical structures were provided previously in MRIDs 42606602 and 43452301.
      7.       Metabolite toxicology. [NA-Remove]
      8.       Endocrine disruption.  No special studies have been conducted to investigate the potential of flutolanil to induce estrogenic or other endocrine effects. The standard battery of required toxicity studies has been completed. These studies include an evaluation of the potential effects on reproduction and development and an evaluation of the pathology of the endocrine organs following repeated or long-term exposure. These studies are generally con- sidered to be sufficient to detect any endocrine effects.   However, no evidence of such effects has been observed in the subchronic, chronic or reproductive studies previously discussed.  Thus, the potential for flutolanil to cause endocrine effects is considered to be minimal.
      9.       Toxicity  endpoint selection.   Flutolanil is of low acute toxicity via all routes
      of administration and did not induce significant maternal or developmental toxicity in either rats or rabbits, even at the limit dose of 1000 mg/kg/day.  Furthermore, no evidence of toxicity was noted following repeated dosing at 1000 mg/kg/day in a 21-day dermal toxicity study.  Thus acute dietary, occupational and residential risk assessments are not considered necessary.  The Agency has identified the 2-year chronic dog as a more appropriate endpoint for the chronic RfD.  This is based on clinical signs (emesis, salivation and soft stool) at 250 mg/kg/day following 65 weeks of exposure. The flutolanil risk assessment team selected a chronic RfD of 0.5 mg/kg/day (NOAEL of 50 mg/kg/day; 10x interspecies factor; 10x intraspecies factor, 1X FQPA SF).  The Agency has also determined that the cancer classification for flutolanil should be "not likely to be carcinogenic to humans," based on the absence of significant tumor increases in two adequate rodent carcinogencity studies.
C. Aggregate Exposure
      1. Dietary exposure. Chronic dietary risk analyses were conducted to
         estimate the potential flutolanil residues in/on the following crops:  rice, peanuts, potato, wheat, corn, cottonseed (undelinted), and soybeans.    Meat, milk, poultry, and egg residues were included.  Analyses were performed using the Lifeline TM Version 3.0 which incorporates data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity.  The number of individuals simulated was 3000.  Chronic exposure estimates to food were based on tolerance levels and assumed 100% crop treatment, yielding the worst case chronic dietary exposure estimates.
         The chronic Population Adjusted Dose (cPAD) was determined to be 0.5 mg/kg/day based on an oral NOAEL of 50 mg/kg/day in the dog chronic study and an uncertainty factor of 100X for inter- and intra-species variations and an FQPA children's safety factor of 1X.
         i. Food.  An acute dietary assessment is not required as there is no acute toxicity associated with flutolanil exposure.
         The chronic dietary exposure estimated food exposure to be 0.0026 mg/kg/day for the U.S. population, which was less than 1% of the cPAD.  The highest exposure group was infants, less than 1 year old, with exposures of .006 mg/kg/day, which represented 1.2 % of the cPAD.  These are considered conservative values as all exposure was based on tolerance levels and assumed all crops were treated with flutolanil.
         ii. Drinking water.  The potential for flutolanil to leach into groundwater has been assessed in two terrestrial field dissipation studies, a long-term terrestrial field dissipation study, and an aquatic field dissipation study.  Under field conditions, the half-life of flutolanil varied from 101 to 123 days in the long-term study, which was consistent with the other field studies, and was approximately 180 days in the aquatic environment.  Flutolanil strongly adsorbs to soil following application and did not exhibit mobility under either terrestrial or aquatic conditions.  Based on these observations, the Agency concluded that the most important means of dissipation in surface water and also in ground water will most likely be dilution.  Due to the lack sufficient monitoring exposure data to complete a dietary risk assessment for flutolanil in drinking water, models that best accounted for the application of flutolanil to rice paddies were used to simulate exposure to flutolanil in drinking water.  Based on the First Approximation Rice Model and Screening Concentrations in Ground Water (SCI-GROW) model, the estimated environmental concentrations (EECs) of flutolanil for acute exposures are 3.8 parts per billion (ppb) for surface water and 0.34 ppb for ground water.  The EECs for chronic exposures are 3.8 ppb for surface water and 0.34 ppb for ground water.
      2.  Non-Dietary Exposure.  As a professional use turf and ornamental fungicide flutolanil is used primarily (>95%) on golf courses for control of brown patch disease (Rhizoctonia solani) as Prostar 50WP (EPA Reg No. 45639-153.  Very limited use of Prostar 50WP may occur on commercial ornamental turf by professional lawn care applicators or on sod farms.  The risk of flutolanil to these non-occupational handlers were assessed for inhalation risk.  The MOE's for these scenarios range from 1.4x10[3] to 4.4 x 10[4] for handlers.
      Post-application inhalation exposure following turfgrass treatment is considered negligible and was not assessed.  Because certain flutolanil products are registered for use on residential lawns, postapplication exposure to infants may result in their hand-to-mouth activities on treated turf.  The MOE's for these scenarios ranged from 6.7 x 10[2] to 1.4 x 10[3].  These MOEs are greater than the LOC of 100 and above the Agency's level of concern.
D. Cumulative Effects
      Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to flutolanil and any other substances and flutolanil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that flutolanil has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's web site at  http://www.epa.gov/ pesticides/cumulative/.
      Flutolanil has demonstrated only minimal toxicity in animal studies.  The mechanism of this toxicity is not known.  Furthermore, there are no available data to indicate that flutolanil has a common mechanism of toxicity with other substances.  Thus, only the potential risks from flutolanil are being considered in this document.
E. Safety Determination
      1.       U.S. Population.  The (cPAD) was determined to be 0.5 mg/kg/day based on an oral NOAEL of 50 mg/kg/day in the dog chronic study and an uncertainty factor of 100X for inter- and intra-species variations and an FQPA children's safety factor of 1X.  Based on the existing tolerances in rice, peanuts and secondary commodities plus the proposed tolerances in soybean and cotton  commodities, the chronic food exposure is estimated to be 0.0026 mg/kg/day for the U.S. population in general.  There is generally no concern for exposures below 100% of the cPAD since the cPAD represents the exposure level at or below which daily exposure over a lifetime will not pose any appreciable risks to human health.  Therefore, there is a reasonable certainty that no harm will result to the U.S. population in general from aggregate exposure to flutolanil.
      i. Acute Risk.  An acute risk assessment is not required as there is no acute toxicity associated with flutolanil exposure.
      ii.Chronic Risk.  Based on the toxicology data base and available information on anticipated residues, the chronic dietary exposure to the U.S. Population (total) was estimated to be 0.0026 mg/kg/day, which was less than 1% of the cPAD. In addition, there is potential for chronic dietary exposure to flutolanil in drinking water.  The DWLOC for the general population is 3 x 104 and for infants less than one year old 8.6 x 10[3].  Based on the use pattern, chronic residential exposure to residues of flutolanil in not expected.  In addition there is potential for chronic dietary exposure to flutolanil in drinking water.  After calculation DWLOCs and comparing them to the EECs for surface and ground water, the EPA concluded that the aggregate exposure to not exceed 100% of the cPAD.   The MOE's scenarios for the non-dietary exposure ranged from 6.7 x 10[2] to 1.4 x 10[3].  These MOEs are greater than the LOC of 100 and are above the Agency's level of concern.  Therefore, these three routes of exposure, when aggregated, present a certainty of no harm to the population.
      2.        Infants and children.  Chronic exposure to infants, less than 1 year old, the highest exposed population subgroup, was 0.006 mg/kg/day, which represented 1.2 % of the cPAD.  Data from reproductive and developmental toxicity studies are generally used to assess the potential for increased sensitivity of infants and children.  No evidence of developmental toxicity was evident.  Therefore, there is no reason to believe there is an increased sensitivity in infants and children. The FQPA safety factor was determined to be 1x.
      3.        Short-term risk.  Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).   EPA has determined that although residential exposure could occur with the use of flutolanil, no toxicological effects have been identified for short-term dermal toxicity. Incidental oral exposure to adult residential handlers is expected to be insignificant and is therefore not assessed. Incidental oral exposure to infants eating treated turf is assessed below under intermediate-term aggregate risk.
F. International Tolerances.
      Canada, Codex, and Mexico do not have maximum residue limits (MRLs) for flutolanil or desisopropyl-flutolanil residues on soybean, seed or cotton, seed.


[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Notices]
[Pages 41543-41545]
[FR Doc No: 2015-17299]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75411; File No. SR-ISE-2015-22]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Extend the SPY Pilot Program

July 9, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 6, 2015, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The ISE proposes to amend its rules to extend the pilot program
that eliminated position and exercise limits for physically-settled
options on the SPDR S&P ETF Trust (``SPY'') (``SPY Pilot Program'').
The text of the proposed rule change is available on the Exchange's Web
site (http://www.ise.com), at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Supplementary Material .01 to Rule
412 and Supplementary Material .01 to Rule 414 to extend the duration
of the SPY Pilot Program through July 12, 2016. This filing does not
propose any substantive changes to the SPY Pilot Program. In proposing
to extend the SPY Pilot Program, the Exchange reaffirms its
consideration of several factors that supported the original proposal
of the SPY Pilot Program, including (1) the liquidity of the option and
the underlying security, (2) the market capitalization of the
underlying security and the related index, (3) the reporting of large
positions and requirements surrounding margin, and (4) financial
requirements imposed by ISE and the Commission.
    With this proposed extension to the SPY Pilot Program, the Exchange
has submitted a report to the Commission reflecting the trading of
standardized SPY options without position limits from January through
May 2015. The report was prepared in the manner specified in the filing
extending the SPY Pilot Program to the current pilot end date of July
12, 2015. The Exchange notes that it is unaware of any problems created
by the SPY Pilot Program and does not foresee any as a result of the
proposed extension. The proposed extension will allow the Exchange and
the Commission to further evaluate the SPY Pilot Program and the effect
it has on the market.
    The Exchange represents that, should the Exchange propose to extend
the pilot program, adopt on a permanent basis the pilot program or
terminate the pilot program, it will submit a new pilot report at least
thirty (30) days before the end of the extended SPY Pilot Program,
which will cover the extended pilot period. The Pilot Report will
detail the size and different types of strategies employed with respect
to positions established as a result of the elimination of position
limits in SPY. In addition, the Pilot Report will note whether any
problems resulted due to the no limit approach and any other
information that may be useful in evaluating the effectiveness of the
SPY Pilot Program. The Pilot Report will compare the impact of the SPY
Pilot Program, if any,

on the volumes of SPY options and the volatility in the price of the
underlying SPY shares, particularly at expiration. In preparing the
report the Exchange will utilize various data elements such as volume
and open interest. In addition the Exchange will make available to
Commission staff data elements relating to the effectiveness of the SPY
Pilot Program.
    Conditional on the findings in the Pilot Report, the Exchange will
file with the Commission a proposal to extend the pilot program, adopt
the pilot program on a permanent basis or terminate the pilot. If the
SPY Pilot Program is not extended or adopted on a permanent basis by
the expiration of the extended pilot, the position limits for SPY would
revert to limits that were in effect prior to the commencement of the
SPY Pilot Program.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6(b) of the Act.\3\ In
particular, the proposal is consistent with Section 6(b)(5) of the
Act,\4\ because it is designed to promote just and equitable principles
of trade, to remove impediments to and perfect the mechanisms of a free
and open market and a national market system and, in general, to
protect investors and the public interest.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that extending the SPY Pilot Program promotes
just and equitable principles of trade by permitting market
participants, including market makers, institutional investors and
retail investors, to establish greater positions when pursuing their
investment goals and needs. The Exchange also believes that
economically equivalent products should be treated in an equivalent
manner so as to avoid regulatory arbitrage, especially with respect to
position limits. Treating SPY and SPX options differently by virtue of
imposing different position limits is inconsistent with the notion of
promoting just and equitable principles of trade and removing
impediments to perfect the mechanisms of a free and open market. At the
same time, the Exchange believes that the elimination of position
limits for SPY options would not increase market volatility or
facilitate the ability to manipulate the market.

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

    The Exchange believes the proposal is consistent with Section
6(b)(8) of the Act \5\ in that it does not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The proposed rule change is not designed to
address any aspect of competition, whether between the Exchange and its
competitors, or among market participants. Instead the proposed rule
change is designed to allow the SPY Pilot Program to continue as all
other self-regulatory organizations currently participating in the SPY
Pilot Program are expected to extend it for an additional year.
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    \5\ 15 U.S.C. 78f(b)(8).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

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

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6) thereunder.\6\
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    \6\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \7\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \8\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay. The
Exchange believes that waiver of the operative delay is consistent with
the protection of investors and the public interest because it will
allow the SPY Pilot Program to continue uninterrupted. The Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest. Therefore, the
Commission hereby waives the operative delay and designates the
proposed rule change operative upon filing.\9\
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    \7\ 17 CFR 240.19b-4(f)(6).
    \8\ 17 CFR 240.19b-4(f)(6)(iii).
    \9\ For purposes only of waiving the 30-day operative delay, the
Commission has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2015-22 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2015-22. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the

Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street NE., Washington, DC 20549 on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
such filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-ISE-2015-22, and should be submitted on or before August
5, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-17299 Filed 7-14-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 28, 2009 (Volume 74, Number 17)]
[Notices]
[Page 4955-4956]
[DOCID:fr28ja09-39]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

January 16, 2009.
    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).

    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the eLibrary link. Enter the docket number, excluding the last three
digits, in the docket number field to access the document. For
assistance, please contact FERC, Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

                                                     Exempt
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                Docket No.                  File date                    Presenter or requester
----------------------------------------------------------------------------------------------------------------
1. CP07-62-000, CP07-63-000..............      1-13-09  Hon. C.A. Dutch Ruppersberger.
                                           ...........  Hon. Barbara A. Mikulski.
                                           ...........  Hon. Ben Cardin.
                                           ...........  Hon. Elijah E. Cummings.
                                           ...........  Hon. John P. Sarbanes.
2. P-2197-000............................      1-14-09  Kara Weishaar (Hon. Richard Burr).
----------------------------------------------------------------------------------------------------------------

Kimberly D. Bose,
Secretary.
[FR Doc. E9-1769 Filed 1-27-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: September 11, 2006 (Volume 71, Number 175)]
[Notices]
[Page 53443-53444]
[DOCID:fr11se06-69]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
To Intervene, Protests, and Comments

August 30, 2006.
    Take notice that the following hydroelectric application has been
filed

with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12722-000.
    c. Date filed: July 31, 2006.
    d. Applicant: UEK Corporation.
    e. Name of Project: Piscataqua Tidal Energy Hydroelectric Project.
    f. Location: The project would be located in the Piscataqua River,
in Rockingham County, New Hampshire.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contacts: Mr. Philippe Vauthier, UEK Corporation, Box
3124 Annapolis, Maryland 21403, phone:<PHONE_NUMBER>.
    i. FERC Contact: Chris Yeakel,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would consist of:
(1) Up to 120 Bi-Directional Hydro Turbine Assembly for Tidal
Deployment units consisting of, (2) two horizontal axis turbines 17
feet in diameter, 32 feet-wide, and 20 feet-long, (3) integrated
generators with a capacity of 336.8 kW each, (4) biological protection
screens and deterrent systems, (5) anchoring systems, (6) mooring
lines, and (7) interconnection transmission lines. The project is
estimated to have an annual generation of 221.79 gigawatt-hours per-
year, which would be sold to a local utility
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street, NE., Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>. This filing may
also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', ``COMPETING APPLICATION'' or
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. Any of the above-
named documents must be filed by providing the original and the number
of copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
[FR Doc. E6-14952 Filed 9-8-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 72 (Tuesday, April 14, 2020)]
[Notices]
[Pages 20694-20696]
[FR Doc No: 2020-07751]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of final guidances for industry entitled ``Guidance on
Chloroquine Phosphate'' and ``Guidance on Hydroxychloroquine Sulfate.''
These guidances provide product-specific recommendations on, among
other things, the design of bioequivalence (BE) studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
June 11, 2010, FDA announced the availability of a guidance for
industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific guidances available to the public on FDA's website.
The guidance entitled ``Guidance on Hydroxychloroquine Sulfate'' was
developed using the process described in that guidance and finalizes
the draft guidance of the same title issued in April 2011. The guidance
entitled ``Guidance on Chloroquine Phosphate'' is being implemented
without prior public comment because FDA has determined that prior
participation for

this guidance is not feasible or appropriate in light of the
Coronavirus Disease 2019 (COVID-19) public health emergency but remains
subject to comment in accordance with the Agency's good guidance
practices.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Guidances; Guidance for
Industry; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance documents.

FOR FURTHER INFORMATION CONTACT: Mara Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4709C, Silver Spring, MD 20993-0002, 301-
796-0683.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website and announced periodically in the Federal Register. The public
is encouraged to submit comments on those recommendations within 60
days of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on March 3, 2020. This notice announces final
product-specific guidances that are posted on FDA's website.
    The guidance entitled ``Guidance on Hydroxychloroquine Sulfate''
was developed using the process described in that guidance and
finalizes the draft guidance of the same title issued in April 2011.
    The guidance entitled ``Guidance on Chloroquine Phosphate'' is
being implemented without prior public comment because FDA has
determined that prior participation for this guidance is not feasible
or appropriate (see 21 CFR 10.115(g)(2)). This document is being
implemented immediately but remains subject to comment in accordance
with the Agency's good guidance practices, and FDA intends to revise
the guidance as warranted and appropriate after reviewing any public
comment we receive.
    There is currently an outbreak of respiratory disease caused by a
novel coronavirus. The virus has been named ``SARS-CoV-2'' and the
disease it causes has been named ``Coronavirus Disease 2019'' (COVID-
19). On January 31, 2020, the Department of Health and Human Services
(HHS) issued a

declaration of a public health emergency related to COVID-19 and
mobilized the Operating Divisions of HHS.\1\ In addition, on March 13,
2020, the President declared a national emergency in response to COVID-
19.\2\ Due to the need to act quickly and efficiently to respond to the
COVID-19 public health emergency, the guidance entitled ``Guidance on
Chloroquine Phosphate'' is being issued as a final guidance and not as
a draft guidance as is usual under the guidance for industry entitled
``Bioequivalence Recommendations for Specific Products.''
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    \1\ Secretary of Health and Human Services Alex M. Azar II,
Determination that a Public Health Emergency Exists. (Jan. 31,
2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx).
    \2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020),
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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II. Drug Products for Which New Final Product-Specific Guidances are
Available

    FDA is announcing the availability of new final product-specific
guidances for industry for drug products containing the following
active ingredients:

       Table 1--Final Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Chloroquine phosphate
Hydroxychloroquine sulfate
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These final guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These final guidances,
represent the current thinking of FDA on, among other things, the
product-specific design of BE studies to support ANDAs. They do not
establish any rights for any person and are not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons with access to the internet may obtain the guidances at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.
    The guidances also are available at FDA's web page titled ``COVID-
19-Related Guidance Documents for Industry, FDA Staff, and Other
Stakeholders'' (https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page titled
``Search for FDA Guidance Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: April 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07751 Filed 4-13-20; 8:45 am]
 BILLING CODE 4164-01-P