[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Pages 60985-60989]
[FR Doc No: 2017-27811]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0466; FRL-9971-10]

Product Cancellation Order for Certain Pesticide Registrations
and Amendments To Terminate Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's order for the cancellations and
amendments to terminate uses, voluntarily requested by the registrants
and accepted by the Agency, of the products listed in Table 1A, Table
1B and Table 2 of Unit II, pursuant to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). This cancellation order follows
an October 3, 2017 Federal Register Notice of Receipt of Requests from
the registrants listed in Table 3 of Unit II to voluntarily cancel and
amend to terminate uses of these product registrations. The
cancellations of products listed in Table 1B would terminate the last
Spirodiclofen products registered for use in the United States. In the
October 3, 2017 notice, EPA indicated that it would issue an order
implementing the cancellations and amendments to terminate uses, unless
the Agency received substantive comments within the 30-day comment
period that would merit its further review of these requests, or unless
the registrants withdrew their requests. The Agency received 5 comments
on the notice but none merited its further review of the requests.
Further, the registrants did not withdraw their requests. Accordingly,
EPA hereby issues in this notice a cancellation order granting the
requested cancellations and amendments to terminate uses. Any
distribution, sale, or use of the products subject to this cancellation
order is permitted only in accordance with the terms of this order,
including any existing stocks provisions.

DATES: The cancellations and amendments are applicable December 26,
2017.

FOR FURTHER INFORMATION CONTACT: Christopher Green, Information
Technology and Resources Management Division (7502P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2017-0466, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. What action is the Agency taking?

    This notice announces the cancellations and amendments to terminate
uses, as requested by registrants, of products registered under FIFRA
section 3 (7 U.S.C. 136a).
    These registrations are listed in sequence by registration number
in Tables 1A, 1B and 2 of this unit.

                                         Table 1A--Product Cancellations
----------------------------------------------------------------------------------------------------------------
        Registration No.           Company No.           Product name                  Active ingredient
----------------------------------------------------------------------------------------------------------------
211-25.........................             211  Pheno Cen Germicidal          Potassium 2-benzyl-4-
                                                  Detergent.                    chlorophenate; o-Phenylphenol,
                                                                                potassium salt; & p-tert-
                                                                                Amylphenol, potassium salt.
211-32.........................             211  Pheno-Cen Spray Disinfectant/ Ethanol; & o-Phenylphenol (NO
                                                  Deodorant.                    INERT USE).
211-36.........................             211  Tri-Cen.....................  Sodium 2-benzyl-4-chlorophenate;
                                                                                o-Phenylphenol, sodium salt; & p-
                                                                                tert-Amylphenol, sodium salt.
211-62.........................             211  Low PH Phenolic 256.........  2-Benzyl-4-chlorophenol; & o-
                                                                                Phenylphenol (NO INERT USE).
769-989........................             769  AllPro Mosquito Barrier       Permethrin.
                                                  Spray.
875-183........................             875  Divosan MH..................  Iodine.
1677-22........................            1677  Mikroklene..................  Oxirane, methyl-, polymer with
                                                                                oxirane, monobutyl ether,
                                                                                compound with iodine; &
                                                                                Phosphoric acid.
1677-58........................            1677  Mikroklene DF...............  Oxirane, methyl-, polymer with
                                                                                oxirane, monobutyl ether,
                                                                                compound with iodine; &
                                                                                Phosphoric acid.
1677-89........................            1677  Bac-Flush...................  Iodine; & Phosphoric acid.
2217-617.......................            2217  Garden Weeder...............  DCPA (or chlorthal-dimethyl?).
3862-18........................            3862  Germ-I-San..................  Nonylphenoxypolyethoxyethanol-
                                                                                iodine complex; & Phosphoric
                                                                                acid.
4787-40........................            4787  Chlorpyrifos Technical......  Chlorpyrifos.
4787-41........................            4787  Nufos Technical.............  Chlorpyrifos.
4787-51........................            4787  Cheminova Abamectin           Abamectin.
                                                  Technical.
4787-62........................            4787  Chlorpyrifos Technical II...  Chlorpyrifos.
5383-114.......................            5383  Polyphase HS32..............  Propiconazole; & Carbamic acid,
                                                                                butyl-, 3-iodo-2-propynyl ester.
5383-120.......................            5383  Polyphase Micro HS30........  Propiconazole; & Carbamic acid,
                                                                                butyl-, 3-iodo-2-propynyl ester.
7616-81........................            7616  Kem Tek Spa Kem Floating      Bromochloro-5-ethyl-5-methyl-2,4-
                                                  Brominator.                   imidazolidinedione.
9480-7.........................            9480  Sani-Wipe...................  Isopropyl alcohol; & Alkyl *
                                                                                dimethyl benzyl ammonium
                                                                                chloride.* (67% C12, 25% C14, 7%
                                                                                C16, 1% C8, C10, and C18).
9688-127.......................            9688  Chemsico Total Release        MGK 264; Pyrethrins; & Piperonyl
                                                  Fogger K.                     butoxide.
10088-23.......................           10088  Spa Concentrated Swimming     Alkyl * dimethyl benzyl ammonium
                                                  Pool Algaecide-Pool Side      chloride. * (60% C14, 30% C16,
                                                  Surface Germicide.            5% C18, 5% C12); & Alkyl *
                                                                                dimethyl ethylbenzyl ammonium
                                                                                chloride * (68% C12, 32% C14).
10088-29.......................           10088  CD Cleaner Disinfectant       Alkyl * dimethyl benzyl ammonium
                                                  Deodorizer Fungicide.         chloride. * (60% C14, 30% C16,
                                                                                5% C18, 5% C12); & Alkyl *
                                                                                dimethyl ethylbenzyl ammonium
                                                                                chloride * (68% C12, 32% C14).
10088-42.......................           10088  10% Liquid Sanitizer          Alkyl * dimethyl benzyl ammonium
                                                  Disinfectant.                 chloride. * (60% C14, 30% C16,
                                                                                5% C18, 5% C12); & Alkyl *
                                                                                dimethyl ethylbenzyl ammonium
                                                                                chloride * (68% C12, 32% C14).
10088-52.......................           10088  Lemon Scented Disinfectant    Alkyl * dimethyl benzyl ammonium
                                                  Cleaner.                      chloride. * (60% C14, 30% C16,
                                                                                5% C18, 5% C12); & Alkyl *
                                                                                dimethyl ethylbenzyl ammonium
                                                                                chloride * (68% C12, 32% C14).
10088-103......................           10088  A-Plus Germicidal Spray &     Alkyl * dimethyl benzyl ammonium
                                                  Wipe Cleaner.                 chloride. * (60% C14, 30% C16,
                                                                                5% C18, 5% C12); & Alkyl *
                                                                                dimethyl ethylbenzyl ammonium
                                                                                chloride * (68% C12, 32% C14).
10088-104......................           10088  Mis-Tery Household            Ethanol; 4-tert-Amylphenol; & o-
                                                  Disinfectant and Deodorizer   Phenylphenol (NO INERT USE).
                                                  Spray.
10088-105......................           10088  C-Spray Disinfectant          Ethanol; 4-tert-Amylphenol; & o-
                                                  Deodorant.                    Phenylphenol (NO INERT USE).
10163-185......................           10163  Prokil Cryolite WDG.........  Cryolite.
10324-130......................           10324  Maquat MC1416-10% CTP.......  Alkyl * dimethyl benzyl ammonium
                                                                                chloride * (60% C14, 30% C16, 5%
                                                                                C18, 5% C12).
33955-474......................           33955  Acme Garden Weed Preventer    DCPA (or chlorthal-dimethyl?).
                                                  Granules.
33955-509......................           33955  Acme Garden Weed Preventer    DCPA (or chlorthal-dimethyl?).
                                                  Spray.

34810-8........................           34810  Wex-Cide Concentrated         2-Benzyl-4-chlorophenol; & o-
                                                  Germicidal Detergent.         Phenylphenol (NO INERT USE).
39039-15.......................           39039  Y-Tex Co-Ral Livestock Dust.  Coumaphos.
39444-9........................           39444  Micropur MP.................  Silver.
47000-91.......................           47000  TR-1 Total Release Fogger...  MGK 264; Pyrethrins; &
                                                                                Permethrin.
47000-95.......................           47000  Fly Bomb 5-1-1..............  MGK 264; Pyrethrins; & Piperonyl
                                                                                butoxide.
47000-144......................           47000  Co-Ral Coumaphos 25% Dust     Coumaphos.
                                                  Base.
51147-5........................           51147  Benzyl Benzoate.............  Benylate.
53345-3........................           53345  Ercocide C..................  Sodium chlorate.
53345-4........................           53345  Ercocide S..................  Sodium chlorate.
59820-5........................           59820  Benzyl Benzoate Miticide      Benylate.
                                                  Technical.
70385-7........................           70385  Clean Carpet Sanitizer......  2-Benzyl-4-chlorophenol; 4-tert-
                                                                                Amylphenol; & o-Phenylphenol (NO
                                                                                INERT USE).
CA-120002......................             100  Heritage Fungicide..........  Azoxystrobin.
NJ-980001......................           70506  Ziram 76DF Fungicide........  Ziram.
WA-090014......................           71297  AFxRD-038...................  1-Methylcyclopropene.
----------------------------------------------------------------------------------------------------------------

              Table 1B--Spirodiclofen Product Cancellations
------------------------------------------------------------------------
                                                             Active
  Registration No.      Company No.     Product name       Ingredient
------------------------------------------------------------------------
264-830.............             264  Spirodiclofen     Spirodiclofen.
                                       Technical.
264-831.............             264  Envidor 2 SC....  Spirodiclofen.
------------------------------------------------------------------------

                           Table 2--Product Registration Amendments To Terminate Uses
----------------------------------------------------------------------------------------------------------------
    Registration No.        Company No.        Product name        Active ingredient     Uses to be terminated
----------------------------------------------------------------------------------------------------------------
264-718.................             264  Spiromesifen           Spiromesifen........  Succulent shelled, edible-
                                           Technical.                                   podded & dry shelled
                                                                                beans; & bulb vegetables
                                                                                (crop group 3-07).
400-577.................             400  Belmont 2.7 FS.......  Metalaxyl...........  Seed Treatment Uses:
                                                                                Canola, mustard seed,
                                                                                rapeseed.
                                                                                Cucurbit Vegetables:
                                                                                Chayote (fruit), Chinese
                                                                                waxgourd, citron melon,
                                                                                gherkin, edible gourd
                                                                                (includes hyotan,
                                                                                cucuzza, Chinese okra,
                                                                                and hechima), momordica
                                                                                spp. (includes balsam
                                                                                apple, balsam pear,
                                                                                bitter melon, Chinese
                                                                                cucumber), muskmelon
                                                                                (includes true
                                                                                cantaloupe, cantaloupe,
                                                                                casaba, crenshaw melon,
                                                                                golden pershaw melon,
                                                                                honeydew melon, honey
                                                                                balls, mango melon,
                                                                                Persian melon, pineapple
                                                                                melon, Santa Claus
                                                                                melon, and snake melon),
                                                                                pumpkin, summer squash
                                                                                (includes crookneck
                                                                                squash, scallop squash,
                                                                                straightneck squash,
                                                                                vegetable marrow,
                                                                                zucchini), winter squash
                                                                                (includes butternut
                                                                                squash, calabaza,
                                                                                hubbard squash), cucumis
                                                                                mixtar, cucumis pepo
                                                                                (includes acorn squash,
                                                                                spaghetti squash),
                                                                                watermelon (includes
                                                                                hybrids and/or varieties
                                                                                of citrullus lanatus).
                                                                                Leafy Vegetables:
                                                                                Amaranth (leafy, Chinese
                                                                                spinach **, tampala),
                                                                                cardoon, celery
                                                                                (including Chinese),
                                                                                celtuce, chervil,
                                                                                chrysanthemum (edible-
                                                                                leaved and garland),
                                                                                corn salad, cress
                                                                                (garden and upland),
                                                                                dandelion, dock, endive,
                                                                                fennel (finochio),
                                                                                lettuce (head and leaf),
                                                                                orach, parsley, purslane
                                                                                (garden and winter),
                                                                                radicchio, rhubarb, and
                                                                                Swiss chard.
                                                                                Brassica (cole) Head,
                                                                                Stem and Leafy
                                                                                Vegetables: Broccoli
                                                                                (including Chinese and
                                                                                raab), Brussels sprouts,
                                                                                cabbage (including
                                                                                Chinese bok choy,
                                                                                Chinese napa and
                                                                                mustard), cauliflower,
                                                                                cavalo broccoli,
                                                                                collards, kale,
                                                                                kohlrabi, mizuna,
                                                                                mustard greens, mustard
                                                                                spinach, and rape
                                                                                greens.
                                                                                Fruiting Vegetables:
                                                                                Eggplant, groundcherry,
                                                                                pepino, pepper
                                                                                (including bell pepper,
                                                                                chili pepper, cooking
                                                                                pepper, pimento, sweet
                                                                                pepper), tomatillo, and
                                                                                tomato.
                                                                                Onions (dry bulb and
                                                                                green):
                                                                                Root and Tuber
                                                                                Vegetables: Arracacha,
                                                                                arrowroot, artichoke
                                                                                (Chinese and Jerusalem),
                                                                                burdock (edible), canna
                                                                                (edible), cassava
                                                                                (bitter and sweet),
                                                                                celery root, chayote,
                                                                                chervil, chicory, chufa,
                                                                                dasheen, ginger,
                                                                                ginseng, horseradish,
                                                                                leren, parsley (turnip-
                                                                                rooted), parsnip, radish
                                                                                (includes oriental
                                                                                dalkon), rutabaga,
                                                                                salsify (includes black
                                                                                and Spanish), skirret,
                                                                                sweet potato, tanier,
                                                                                turmeric, turnip, yam
                                                                                bean (jicama, manioc
                                                                                pea), yam.
5383-104................            5383  Troy Mergal K14......  5-Chloro-2-methyl-    Metal working fluids.
                                                                  3(2H)-
                                                                  isothiazolone; & 2-
                                                                  Methyl-3(2H)-
                                                                  isothiazolone.
10807-199...............           10807  Misty Dualcide P3 RTU  Permethrin..........  Adult mosquito control
                                                                                section.
19713-156...............           19713  Drexel Captan 4L       Captan..............  Turf, sod farm, golf
                                           Fungicide.                                   course, lawn seedbed,
                                                                                soil and greenhouse
                                                                                bench treatment.
19713-235...............           19713  Drexel Captan 50W....  Captan..............  Turf, sod farm, golf
                                                                                course, lawn seedbed,
                                                                                soil and greenhouse
                                                                                bench treatment.

19713-258...............           19713  Drexel Captan          Captan..............  Turf (golf courses), sod
                                           Technical.                                   farms, soil seedbeds and
                                                                                greenhouse bench
                                                                                treatments.
19713-268...............           19713  Drexel Kaptan 50W....  Captan..............  Turf, sod farm, golf
                                                                                course, lawn seedbed,
                                                                                soil and greenhouse
                                                                                bench treatment.
19713-362...............           19713  Drexel 80% Captan....  Captan..............  Turf, sod farm, golf
                                                                                course, lawn seedbed,
                                                                                soil and greenhouse
                                                                                bench treatment.
19713-385...............           19713  Drexel 80% Kaptan....  Captan..............  Turf, sod farm, golf
                                                                                course, lawn seedbed,
                                                                                soil and greenhouse
                                                                                bench treatment.
19713-405...............           19713  Drexel Captan 80 EDF.  Captan..............  Turf, sod farm, golf
                                                                                course, lawn seedbed,
                                                                                soil and greenhouse
                                                                                bench treatment.
19713-500...............           19713  Drexel Captan          Captan..............  Seedbeds and greenhouse
                                           Technical Two.                               bench treatments.
19713-631...............           19713  Drexel Captan          Captan..............  Turf (golf courses), sod
                                           Technical 97%.                               farms, soil seedbeds and
                                                                                greenhouse bench
                                                                                treatments.
19713-644...............           19713  DCC Captan 4L          Captan..............  Turf, sod farm, golf
                                           (Alternate name:                             course, lawn seedbed,
                                           Captan 4L).                                  soil and greenhouse
                                                                                bench treatment.
19713-646...............           19713  Drexel Captan 50W      Captan..............  Turf, sod farm, golf
                                           Fungicide.                                   course, lawn seedbed,
                                                                                soil and greenhouse
                                                                                bench treatment.
19713-652...............           19713  Drexel Captan 80 WDG.  Captan..............  Turf, sod farm, golf
                                                                                course, lawn seedbed,
                                                                                soil and greenhouse
                                                                                bench treatment.
33658-33................           33658  Reality Termiticide/   Permethrin..........  Agricultural crop use
                                           Insecticide.                                 directions section.
34704-427...............           34704  Captan 50-W..........  Captan..............  Soil and greenhouse bench
                                                                                treatment.
34704-1075..............           34704  Captan 80 WDG........  Captan..............  Grasses (ornamental in
                                                                                non-pastured areas)/turf
                                                                                (golf course), (lawn
                                                                                seedbeds)/turf (sod
                                                                                farms), soil and
                                                                                greenhouse bench
                                                                                treatment.
34704-1076..............           34704  Captan 4L............  Captan..............  Grasses (ornamentals in
                                                                                non-pastured areas and
                                                                                lawn seedbeds), soil,
                                                                                and greenhouse bench
                                                                                treatment.
42750-145...............           42750  Imazethapyr TGAI.....  Imazethapyr.........  Clearfield rice.
42750-146...............           42750  Imazeth 2SC..........  Imazethapyr,          Clearfield rice.
                                                                  ammonium salt.
64321-1.................           64321  Bio Kill Brand         Permethrin..........  Food crops.
                                           Insecticide.
66675-3.................           66675  CS 2005--(Magna-Bon..  Copper sulfate        Swimming pool, outdoor
                                          Bahama Klear)-          pentahydrate.         hot tub and spa usages,
                                           Alternate.                                   and post-harvest fruit
                                                                                and vegetable wash.
91232-3.................           91232  FD Tebuconazole 3.6F.  Tebuconazole........  Seed treatment use on
                                                                                corn.
----------------------------------------------------------------------------------------------------------------

    Table 3 of this unit includes the names and addresses of record for
all registrants of the products in Table 1A, Table 1B and Table 2 of
this unit, in sequence by EPA company number. This number corresponds
to the first part of the EPA registration numbers of the products
listed in Table 1A, Table 1B and Table 2 of this unit.

         Table 3--Registrants of Cancelled and Amended Products
------------------------------------------------------------------------
           EPA company No.                 Company name and address
------------------------------------------------------------------------
100.................................  Syngenta Crop Protection, LLC, 410
                                       Swing Road, P.O. Box 18300,
                                       Greensboro, NC 27419-8300.
211.................................  Central Solutions, Inc., 401
                                       Funston Road, Kansas City, KS
                                       66115.
264.................................  Bayer CropScience, LP, 2 T.W.
                                       Alexander Drive, P.O. Box 12014,
                                       Research Triangle Park, NC 27709.
400.................................  MacDermid Agricultural Solutions,
                                       Inc., C/O Arysta LifeScience
                                       North America, LLC, 15401 Weston
                                       Parkway, Suite 150, Cary, NC
                                       27513.
769.................................  Value Gardens Supply, LLC, D/B/A
                                       Value Garden Supply, Agent Name:
                                       JM Specialty Consulting, LLC, 44
                                       Pine Lane Ranch Road, Laurel, MS
                                       39443.
875.................................  Diversey, Inc., 1410 Newman Road,
                                       Racine, WI 53406.
1677................................  Ecolab, Inc., 1 Ecolab Place, St.
                                       Paul, MN 55102.
2217................................  PBI/Gordon Corp., 1217 West 12th
                                       Street, P.O. Box 014090, Kansas
                                       City, MO 64101-0090.
3862................................  ABC Compounding Co., Inc., P.O.
                                       Box 80729, Conyers, GA 30013.
4787................................  Cheminova A/S, Agent Name: FMC
                                       Corporation, 1735 Market Street,
                                       Room 1971, Philadelphia, PA
                                       19103.
5383................................  Troy Chemical Corporation, Agent
                                       Name: Troy Corporation, 8
                                       Vreeland Road, Florham Park, NJ
                                       07932.
7616................................  Kik Pool Additives, Inc., Agent
                                       Name: Delta Analytical
                                       Corporation, 12510 Prosperity
                                       Drive, Suite 160, Silver Spring,
                                       MD 20904.
9480................................  Professional Disposables
                                       International, Inc., Agent Name:
                                       Delta Analytical Corp., 12510
                                       Prosperity Drive, Suite 160,
                                       Silver Spring, MD 20904.
9688................................  Chemsico, A Division of United
                                       Industries Corp., P.O. Box
                                       142642, St. Louis, MO 63114-0642.
10088...............................  Athea Laboratories, Inc., P.O. Box
                                       240014, Milwaukee, WI 53224.
10163...............................  Gowan Company, P.O. Box 5569,
                                       Yuma, AZ 85366.
10324...............................  Mason Chemical Company, 723 W.
                                       Algonquin Rd., Suite B, Arlington
                                       Heights, IL 60005.
10807...............................  Amrep, Inc., Agent Name: Zep, Inc.
                                       C/O Compliance Services, 1259
                                       Seabord Industrial Blvd., NW,
                                       Atlanta, GA 30318.
19713...............................  Drexel Chemical Company, P.O. Box
                                       13327, Memphis, TN 38113-0327.
33658...............................  Gharda Chemicals Limited, Agent
                                       Name: IPM Resources, LLC, 4032
                                       Crockers Lake Blvd., Ste. 818,
                                       Sarasota, FL 34238.
33955...............................  PBI/Gordon Corp., 1217 West 12th
                                       Street, P.O. Box 014090, Kansas
                                       City, MO 64101-0090.
34704...............................  Loveland Products, Inc., P.O. Box
                                       1286, Greeley, CO 80632-1286.
34810...............................  Wexford Labs, Inc., 325
                                       Leffingwell Ave., Kirkwood, MI
                                       63122.

39039...............................  Y-Tex Corporation, 1825 Big Horn
                                       Avenue, Cody, WY 82414.
39444...............................  Katadyn Produkte, D/B/A Katadyn
                                       Products, Inc., Agent Name:
                                       Regwest Company, LLC, 8203 West
                                       20th Street, Suite A, Greeley, CO
                                       80634-4696.
42750...............................  Albaugh, LLC, P.O. Box 2127,
                                       Valdosta, GA 31604-2127.
47000...............................  Chem-Tech, Ltd., 110 Hopkins
                                       Drive, Randolph, WI 53956.
51147...............................  Vertellus, LLC, 201 N. Illinois
                                       Street, Suite 1800, Indianapolis,
                                       IN 46204.
53345...............................  Erco Worldwide, Agent Name: Lewis
                                       & Harrison, LLC, 122 C Street NW,
                                       Suite 505, Washington, DC 20001.
59820...............................  Allergopharma Joachim, Agent Name:
                                       Brazos Associates, Inc., 621 West
                                       4th Street, Cordell, OK 73632.
64321...............................  Jesmond Holding AG, Agent Name:
                                       Registrations by Design, Inc.,
                                       P.O. Box 1019, Salem, VA 24153-
                                       3805.
66675...............................  Magna-Bon II, LLC, 1531 NW 25th
                                       Drive, Okeechobee, FL 34972.
70385...............................  ProRestore Products, Agent Name:
                                       Lewis & Harrison, LLC, 122 C
                                       Street NW, Suite 505, Washington,
                                       DC 20001.
70506...............................  United Phosphorus, Inc., 630
                                       Freedom Business Center, Suite
                                       402, King of Prussia, PA 19406.
71297...............................  AgroFresh, Inc., 400 Arcola Road,
                                       P.O. Box 7000, Collegeville, PA
                                       19426.
91232...............................  Fengdeng USA, Inc., 123 Cornell
                                       Road, Bala Cynwyd, PA 19004.
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    During the public comment period provided EPA received 5 general
comments, 3 specifically concerning the chemical, Chlorpyrifos. The
Agency does not believe that the comments submitted during the comment
period merits further review or the denial of the requests for the
voluntary cancellations of products listed in Table 1A and Table 1B of
Unit II or the requests for the amendments to terminate uses in Table 2
of Unit II.

IV. Cancellation Order

    Pursuant to FIFRA section 6(f) (7 U.S.C. 136d(f)(1)), EPA hereby
approves the requested cancellations and amendments to terminate uses
of the registrations identified in Tables 1A, 1B and 2 of Unit II.
Accordingly, the Agency hereby orders that the product registrations
identified in Tables 1A, 1B and 2 of Unit II are canceled and amended
to terminate the affected uses. The effective date of the cancellations
that are subject of this notice is December 26, 2017. Any distribution,
sale, or use of existing stocks of the products identified in Tables
1A, 1B and 2 of Unit II in a manner inconsistent with any of the
provisions for disposition of existing stocks set forth in Unit VI will
be a violation of FIFRA.

V. What is the Agency's authority for taking this action?

    Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a
registrant of a pesticide product may at any time request that any of
its pesticide registrations be canceled or amended to terminate one or
more uses. FIFRA further provides that, before acting on the request,
EPA must publish a notice of receipt of any such request in the Federal
Register. Thereafter, following the public comment period, the EPA
Administrator may approve such a request. The notice of receipt for
this action was published for comment in the Federal Register of
October 3, 2017 (82 FR 46052) (FRL-9966-85). The comment period closed
on November 2, 2017.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
action. The existing stocks provision for the products subject to this
order is as follows.

A. For Products 211-25, 211-32, 211-36, 211-62 and 34810-8

    The registrant has requested to the Agency via letter to sell
existing stocks for an 18-month period for products 211-25, 211-32,
211-36, 211-62 and 34810-8.

B. For the Products Listed in Table 1b, 264-830 and 264-831

    As there are no risk concerns for these products, after December
31, 2020, the registrant will be prohibited from producing, selling, or
distributing existing stocks of products containing Spirodiclofen.

C. For Products 47000-91, 47000-95 and 47000-144

    The registrant has requested to the Agency via letter to
manufacture and/or distribute existing stocks for a 24-month period
starting the date of the request which was April 25, 2017 for products
47000-91 and 47000-95, and June 28, 2017 for product 47000-144.
    For all other voluntary product cancellations identified in Table
1A of Unit II, the registrants may continue to sell and distribute
existing stocks of the products listed in Table 1A until December 26,
2018, which is December 26, 2018 .
    Thereafter, the registrants are prohibited from selling or
distributing the products listed in Table 1A of Unit II, except for
export in accordance with FIFRA section 17 (7 U.S.C. 136o) or for
proper disposal.
    Now that EPA has approved product labels reflecting the requested
amendments to terminate uses for the products listed in Table 2 of Unit
II, registrants are permitted to sell or distribute the products listed
in Table 2 of Unit II, under the previously approved labeling until
June 26, 2019, unless other restrictions have been imposed. Thereafter,
registrants will be prohibited from selling or distributing the
products whose labels include the terminated uses identified in Table 2
of Unit II, except for export consistent with FIFRA section 17 or for
proper disposal.
    Persons other than the registrant may sell, distribute, or use
existing stocks of canceled products and products whose labels include
the terminated uses until supplies are exhausted, provided that such
sale, distribution, or use is consistent with the terms of the
previously approved labeling on, or that accompanied, the canceled
products and terminated uses.

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

    Dated: December 5, 2017.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2017-27811 Filed 12-22-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31050-31051]
[FR Doc No: 2015-13104]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1659]

Established Conditions: Reportable Chemistry, Manufacturing, and
Controls Changes for Approved Drug and Biologic Products; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Established
Conditions: Reportable CMC Changes for Approved Drug and Biologic
Products.'' The purpose of this guidance is to provide applicants of
new drug applications, abbreviated new drug applications, and biologic
license applications with FDA's current thinking on established
conditions (i.e., the chemistry, manufacturing, and controls (CMC)
information in a submission that would require reporting to FDA if
changed for approved drug and biologic products, per the current
regulations). This guidance also describes those sections of a common
technical document formatted application that typically contain
information that meets the definition of established conditions, and
provides considerations for managing changes to established conditions
over the life cycle of an approved product.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 31, 2015.

ADDRESSES: Submit written requests for single copies of the draft
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; or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research (CBER), Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist the office in processing your requests. The draft guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-
7800. See the SUPPLEMENTARY INFORMATION section for electronic access
to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ashley Boam, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>; or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Established Conditions: Reportable CMC Changes for Approved
Drug and Biologic Products.'' The current regulations for drugs and
biologics require applicants with approved drug or biologic products to
notify FDA about each change in each condition established in the
approved application beyond the variations already provided for in the
application (see 21 CFR 314.70) or each change in the product,
production process, quality controls, equipment, facilities,
responsible personnel, or labeling established in the approved license
application (see 21 CFR 601.12). FDA guidance documents clarify the
recommended reporting mechanism (i.e., supplement, annual report) for
postapproval CMC changes. This draft guidance has been developed to
address the lack of clarity with respect to what CMC information in an
application constitutes an established condition.
    A better understanding of which elements of the CMC information
constitute established conditions to FDA and where in an application
these are generally expected to be described will allow for a more
effective postapproval submission strategy (e.g., effective use of risk
management

principles in the International Conference on Harmonisation (ICH) Q9,
and knowledge management as defined in ICH Q10) by the regulated
industry. This will also provide the FDA pathways to better regulate
postapproval changes by utilizing more flexibility and risk-based
principles, as envisioned by the pharmaceutical product quality
initiatives laid out in FDA's ``Pharmaceutical Current Good
Manufacturing Practices (cGMPs) for the 21st Century--A Risk Based
Approach'' (see http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM071836).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Established
Conditions: Reportable CMC Changes for Approved Drug and Biologic
Products.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 211, 314, and 601
have been approved under OMB control numbers 0910-0139, 0910-0001, and
0910-0338, respectively.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: May 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13104 Filed 5-29-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61008-61009]
[FR Doc No: 2020-21455]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1824]

Assessing COVID-19-Related Symptoms in Outpatient Adult and
Adolescent Subjects in Clinical Trials of Drugs and Biological Products
for COVID-19 Prevention or Treatment; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Assessing
COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects
in Clinical Trials of Drugs and Biological Products for COVID-19
Prevention or Treatment.'' Sponsors may encounter challenges in
identifying methods to assess the numerous and heterogeneous
Coronavirus Disease 2019 (COVID-19)-related symptoms across subjects
when designing clinical trials of drugs to treat or prevent COVID-19 in
adult and adolescent outpatient subjects. To assist sponsors, this
guidance describes an example with a set of common COVID-19-related
symptoms as well as an approach to their measurement for use in
clinical trials. Given the public health emergency presented by COVID-
19, this guidance document is being implemented without prior public
comment because FDA has determined that prior public participation is
not feasible or appropriate, but it remains subject to comment in
accordance with the Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal
Register on September 29, 2020. The guidance document is immediately in
effect, but it remains subject to comment in accordance with the
Agency's good guidance practices.

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-2020-D-1824 for ``Assessing COVID-19-Related Symptoms in Outpatient
Adult and Adolescent Subjects in Clinical Trials of Drugs and
Biological Products for COVID-19 Prevention or Treatment.'' 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the 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; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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 document.

FOR FURTHER INFORMATION CONTACT: Elektra Papadopoulos, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6445, Silver Spring, MD 20993-0002, 301-
796-0967; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903

New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Assessing COVID-19-Related Symptoms in Outpatient Adult and
Adolescent Subjects in Clinical Trials of Drugs and Biological Products
for COVID-19 Prevention or Treatment.'' Sponsors may encounter
challenges in identifying methods to assess the numerous and
heterogeneous COVID-19-related symptoms across subjects when designing
clinical trials of drugs to treat or prevent COVID-19 in adult and
adolescent outpatient subjects. In many instances, daily assessment of
all COVID-19-related symptoms may not be feasible.
    To assist sponsors, the guidance describes an example with a set of
common COVID-19-related symptoms derived from information provided by
the Centers for Disease Control and Prevention as of August 28, 2020,
as well as an approach to their measurement for use in clinical trials.
    The guidance also includes considerations and recommendations for
handling data and for standardizing other COVID-19-related clinical
trial assessments for trial subjects.
    In light of the public health emergency related to COVID-19
declared by the Secretary of the Department of Health and Human
Services (HHS), FDA has determined that prior public participation for
this guidance is not feasible or appropriate and is issuing this
guidance without prior public comment (see section 701(h)(1)(C)(i) of
the FD&C Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR 10.115(g)(2)). This
guidance document is being implemented immediately, but it remains
subject to comment in accordance with the Agency's good guidance
practices. FDA will review comments, and the guidance will be updated
accordingly.
    This guidance is intended to remain in effect for the duration of
the public health emergency related to COVID-19 declared by HHS,
including any renewals made by the Secretary in accordance with section
319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).
However, the recommendations and processes described in the guidance
are expected to assist the Agency more broadly in its efforts to
provide sponsors with considerations for the assessment of COVID-19-
related symptoms in outpatient adult and adolescent subjects in
clinical trials evaluating drugs to treat or prevent COVID-19 beyond
the termination of the COVID-19 public health emergency and reflect the
Agency's current thinking on this issue. Therefore, within 60 days
following the termination of the public health emergency, FDA intends
to revise and replace this guidance with any appropriate changes based
on comments received on this guidance and the Agency's experience with
implementation.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Assessing COVID-19-Related Symptoms in
Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs
and Biological Products for COVID-19 Prevention or Treatment.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001; the collections of information in 21 CFR parts 312
and 320 have been approved under OMB control number 0910-0014; the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338; the collections of information in 21 CFR
parts 50 and 56 have been approved under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or
https://www.regulations.gov.

    Dated: September 18, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21455 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P