[Federal Register Volume 87, Number 60 (Tuesday, March 29, 2022)]
[Rules and Regulations]
[Pages 17942-17949]
[FR Doc No: 2022-06395]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 524, 529, 556, and 558

[Docket No. FDA-2021-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during October, November, and December 2021. FDA
is informing the public of the availability of summaries of the basis
of approval and of environmental review documents, where applicable.
The animal drug regulations are also being amended to improve the
accuracy of the regulations.

DATES: This rule is effective March 29, 2022.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Approvals

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during October, November, and December
2021, as listed in table 1. In addition, FDA is informing the public of
the availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>. Persons
with access to the internet may obtain these documents at the CVM FOIA
Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
    FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

                        Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
       Approval date        File No.         Sponsor              Product name              Species          Effect of the action     Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 1, 2021...........   200-691  Virbac AH, Inc., P.O.  RAC 45 CATTLE          Cattle................  Original approval as   FOI Summary.
                                       Box 162059, Fort       (ractopamine                                   a generic copy of
                                       Worth, TX 76161.       hydrochloride Type A                           NADA 141-221.
                                                              medicated article).
October 20, 2021..........   200-604  Dechra Veterinary      Amoxicillin and        Dogs and cats.........  Original approval as   FOI Summary.
                                       Products LLC, 7015     Clavulanate                                    a generic copy of
                                       College Blvd., Suite   Potassium for Oral                             NADA 055-101.
                                       525, Overland Park,    Suspension.
                                       KS 66211.
October 28, 2021..........   200-588  Sparhawk               Florfenicol Injection  Cattle................  Original approval as   FOI Summary.
                                       Laboratories, Inc.,    (florfenicol)                                  a generic copy of
                                       12340 Santa Fe Trail   Injectable Solution.                           NADA 141-063.
                                       Dr., Lenexa, KS
                                       66215.
October 29, 2021..........   200-628  Sparhawk               Enrofloxacin 100       Cattle and swine......  Original approval as   FOI Summary.
                                       Laboratories, Inc.,    (enrofloxacin)                                 a generic copy of
                                       12340 Santa Fe Trail   Injectable Solution.                           NADA 141-068.
                                       Dr., Lenexa, KS
                                       66215.
October 29, 2021..........   141-348  Zoetis Inc., 333       SYNOVEX ONE Grower     Cattle................  Supplemental approval  FOI Summary.
                                       Portage St.,           (trenbolone acetate                            adding cattle fed in
                                       Kalamazoo, MI 49007.   and estradiol                                  confinement for
                                                              benzoate extended-                             slaughter.
                                                              release implants).
November 1, 2021..........   200-711  Ceva Sante Animale,    TULAVEN 100            Cattle and swine......  Original approval as   FOI Summary.
                                       10 Avenue de la        (tulathromycin                                 a generic copy of
                                       Ballasti[egrave]re,    injection)                                     NADA 141-244.
                                       33500 Libourne,        Injectable Solution.
                                       France.
November 3, 2021..........   200-712  Ceva Sante Animale,    TULAVEN 25             Cattle and swine......  Original approval as   FOI Summary.
                                       10 Avenue de la        (tulathromycin                                 a generic copy of
                                       Ballasti[egrave]re,    injection)                                     NADA 141-349.
                                       33500 Libourne,        Injectable Solution.
                                       France.
November 3, 2021..........   141-508  Elanco US Inc., 2500   EXPERIOR (lubabegron)  Cattle................  Supplemental approval  FOI Summary.
                                       Innovation Way,        Type A medicated                               adding tolerances
                                       Greenfield, IN 46140.  article.                                       for residues in
                                                                                edible tissues of
                                                                                cattle.
November 12, 2021.........   200-668  Virbac AH, Inc., P.O.  TULISSIN 25            Cattle and swine......  Original approval as   FOI Summary.
                                       Box 162059, Fort       (tulathromycin                                 a generic copy of
                                       Worth, TX 76161.       injection)                                     NADA 141-349.
                                                              Injectable Solution.
November 15, 2021.........   200-253  Bimeda Animal Health   PROSTAMATE (dinoprost  Cattle................  Supplemental approval  FOI Summary.
                                       Ltd., 1B The Herbert   tromethamine                                   for use with
                                       Building, The Park,    injection)                                     gonadorelin or with
                                       Carrickmines, Dublin   Injectable Solution.                           progesterone
                                       18, Ireland.                                                          intravaginal inserts.
November 15, 2021.........   200-669  Virbac AH, Inc., P.O.  TULISSIN 100           Cattle and swine......  Original approval as   FOI Summary.
                                       Box 162059, Fort       (tulathromycin                                 a generic copy of
                                       Worth, TX 76161.       injection)                                     NADA 141-244.
                                                              Injectable Solution.

November 22, 2021.........   200-695  Virbac AH, Inc., P.O.  TIA 12.5% (tiamulin    Swine.................  Original approval as   FOI Summary.
                                       Box 162059, Fort       hydrogen fumarate)                             a generic copy of
                                       Worth, TX 76161.       Liquid Concentrate.                            NADA 140-916.
November 24, 2021.........   200-714  Aurora                 BARRIER for Cats       Cats..................  Original approval as   FOI Summary.
                                       Pharmaceutical, Inc,   (imidacloprid and                              a generic copy of
                                       1196 Highway 3         moxidectin) Topical                            NADA 141-254.
                                       South, Northfield,     Solution.
                                       MN 55057-3009.
December 10, 2021.........   200-705  Elanco US Inc., 2500   ZOASHIELD (zoalene)    Chickens and turkeys..  Original approval as   FOI Summary.
                                       Innovation Way,        Type A medicated                               a generic copy of
                                       Greenfield, IN 46140.  article and BMD                                NADA 141-085.
                                                              (bacitracin
                                                              methylenedisalicylat
                                                              e) Type A medicated
                                                              article.
December 21, 2021.........   141-552  Jaguar Animal Health,  CANALEVIA-CA1          Dogs..................  Conditional approval   FOI Summary.
                                       200 Pine St., suite    (crofelemer delayed-                           for treatment of
                                       600, San Francisco,    release tablets).                              chemotherapy-induced
                                       CA 94104.                                                             diarrhea.
December 23, 2021.........   141-521  Zoetis Inc., 333       SIMPARICA TRIO         Dogs..................  Supplemental approval  FOI Summary.
                                       Portage St.,           (sarolaner,                                    for the prevention
                                       Kalamazoo, MI 49007.   moxidectin, and                                of Borrelia
                                                              pyrantel chewable                              burgdorferi
                                                              tablets) Chewable                              infection as a
                                                              Tablet.                                        direct result of
                                                                                killing Ixodes
                                                                                scapularis vector
                                                                                ticks and for the
                                                                                treatment and
                                                                                control of L4 and
                                                                                immature adult
                                                                                Ancylostoma caninum.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Change of Sponsor

    Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has
informed FDA that it has transferred ownership of, and all rights and
interest in, the NADAs and ANADAs listed below to Dechra, Ltd.,
Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire,
BD23 2RW, United Kingdom:

------------------------------------------------------------------------
             File No.                           Product name
------------------------------------------------------------------------
047-955...........................  ROMPUN (xylazine hydrochloride)
                                     Injectable (20 mg).
047-956...........................  ROMPUN (xylazine hydrochloride)
                                     Injectable (100 mg).
200-322...........................  Butorphanol Tartrate Injection.
200-408...........................  Butorphanol Tartrate Injection.
------------------------------------------------------------------------

    Thorn Bioscience LLC, 1044 East Chestnut St., Louisville, KY 40204
has informed FDA that it has transferred ownership of, and all rights
and interest in, NADA 141-319 for SUCROMATE Equine (deslorelin acetate
injection) to Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd.,
Skipton, North Yorkshire, BD23 2RW, United Kingdom.
    As provided in the regulatory text, the animal drug regulations are
amended to reflect these changes of sponsorship.

III. Technical Amendments

    FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
     21 CFR 510.600 is amended to add Jaguar Animal Health and
remove Thorn Bioscience LLC from the list of sponsors of approved
applications.
     21 CFR 520.88h is amended to correct indications for use
in cats of an oral suspension containing amoxicillin and clavulanate.
     21 CFR 520.2455 is amended to correct a spelling error in
the limitations for use of tiamulin in drinking water of swine.
     21 CFR 522.230 is amended to add the caution that
buprenorphine injectable solution is a Schedule III opioid under the
Controlled Substances Act.
     21 CFR 522.690 is amended to reflect revised indications
for use of dinoprost tromethamine injectable solution in mares.
     21 CFR 522.1940 is amended to reflect the approved classes
of cattle and limitations for use of progesterone and estradiol
benzoate ear implants.
     21 CFR 522.2343 is amended to reflect the approved classes
of cattle and limitations for use of testosterone propionate and
estradiol benzoate ear implants.
     21 CFR 556.240 is amended to reflect the use of revised
food consumption values in establishing permitted concentrations of
residues of estradiol and related esters in edible tissues of cattle.
The basis for this action is explained in the FOI Summary for
supplemental NADA 141-348, approved October 29, 2021. The section is
also amended to reflect a cross reference for testosterone propionate
and estradiol benzoate implants, recently redesignated as 21 CFR
522.2343.
     21 CFR 558.254 is amended to reflect the approved
conditions of use for famphur in feed.
     21 CFR 558.355 is amended to reflect use of medicated
feeds containing monensin alone or in combination with bacitracin
methylenedisalicylate in revised classes of chickens.
     21 CFR 558.555 is amended to correct a spelling error in
the permitted combination use of semduramicin in medicated feed.
     21 CFR 558.633 is amended to revise expiration dates for
use of pelleted or crumbled tylvalosin medicated swine feeds.
     21 CFR 558.680 is amended to reflect the correct sponsor
of an application for use of Type C medicated turkey feeds containing
zoalene.

IV. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth

technical amendments to the regulations to codify recent actions on
approved new animal drug applications and corrections to improve the
accuracy of the regulations, and as such does not impose any burden on
regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Dairy products, Foods, Meat and meat products.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 516, 520, 522, 524, 529, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600:
0
a. In the table in paragraph (c)(1), add in alphabetical order an entry
for ``Jaguar Animal Health'' and remove the entry for ``Thorn
Bioscience LLC''; and
0
b. In the table in paragraph (c)(2), remove the entry for ``051330''
and add in numerical order an entry for ``086149''.
    The additions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
Jaguar Animal Health, 200 Pine St., Suite 600, San                086149
 Francisco, CA 94104....................................

                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
086149...................  Jaguar Animal Health, 200 Pine St., Suite
                            600,
                           San Francisco, CA 94104.

                              * * * * * * *
------------------------------------------------------------------------

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
3. The authority citation for part 516 continues to read as follows:

    Authority  21 U.S.C. 360ccc, 360ccc-2, 371.

0
4. Add Sec.  516.498 to subpart C to read as follows:

Sec.  516.498  Crofelemer.

    (a) Specifications. Each delayed-release tablet contains 125
milligrams (mg) crofelemer.
    (b) Sponsor. See No. 086149 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 1 tablet orally twice
daily for 3 days for dogs weighing <=140 pounds. Administer 2 tablets
orally twice daily for 3 days for dogs weighing >140 pounds.
    (2) Indications for use. For the treatment of chemotherapy-induced
diarrhea in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
5. The authority citation for part 520 continues to read as follows:

    Authority:  21 U.S.C. 360b.

0
6. Revise Sec.  520.88h to read as follows:

Sec.  520.88h  Amoxicillin trihydrate and clavulanate potassium for
oral suspension.

    (a) Specifications. When constituted, each milliliter (mL) of
suspension contains amoxicillin trihydrate equivalent to 50 milligrams
(mg) amoxicillin and clavulanate potassium equivalent to 12.5 mg
clavulanic acid.
    (b) Sponsors. See Nos. 017033, 054771, and 069043 in Sec.
510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 6.25 mg/lb (1 mL/10 lb
of body weight) twice a day. Skin and soft tissue infections such as
abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and
periodontal infections should be treated for 5 to 7 days or for 48
hours after all signs have subsided. If no

response is seen after 5 days of treatment, therapy should be
discontinued and the case reevaluated. Deep pyoderma may require
treatment for 21 days; the maximum duration of treatment should not
exceed 30 days.
    (ii) Indications for use. Treatment of skin and soft tissue
infections such as wounds, abscesses, cellulitis, superficial/juvenile
and deep pyoderma due to susceptible strains of the following
organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-
lactamase-producing Staphylococcus aureus, Staphylococcus spp.,
Streptococcus spp., and Escherichia coli. Treatment of periodontal
infections due to susceptible strains of both aerobic and anaerobic
bacteria.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 62.5 mg (1 mL) twice daily. Skin and soft
tissue infections such as abscesses and cellulitis/dermatitis should be
treated for 5 to 7 days or 48 hours after all symptoms have subsided,
not to exceed 30 days. If no response is seen after 3 days of
treatment, therapy should be discontinued and the case reevaluated.
Urinary tract infections may require treatment for 10 to 14 days or
longer. The maximum duration of treatment should not exceed 30 days.
    (ii) Indications for use. Treatment of skin and soft tissue
infections, such as wounds, abscesses, and cellulitis/dermatitis due to
susceptible strains of the following organisms: Beta-lactamase-
producing Staphylococcus aureus, non-beta-lactamase-producing
Staphylococcus aureus, Staphylococcus spp., Streptococcus spp.,
Escherichia coli, Pasteurella multocida, and Pasteurella spp. Urinary
tract infections (cystitis) due to susceptible strains of E. coli.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

0
7. In Sec.  520.2090, revise paragraph (c)(2) to read as follows:

Sec.  520.2090  Sarolaner, moxidectin, and pyrantel.

* * * * *
    (c) * * *
    (2) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis and for the treatment and control of
roundworm (immature adult and adult Toxocara canis and adult Toxascaris
leonina) and hookworm (L4, immature adult, and adult Ancylostoma
caninum and adult Uncinaria stenocephala) infections. Kills adult fleas
(Ctenocephalides felis) and is indicated for the treatment and
prevention of flea infestations, and the treatment and control of tick
infestations with Amblyomma americanum (lone star tick), Amblyomma
maculatum (Gulf Coast tick), Dermacentor variabilis (American dog
tick), Ixodes scapularis (black-legged tick), and Rhipicephalus
sanguineus (brown dog tick) for 1 month in dogs and puppies 8 weeks of
age and older, and weighing 2.8 pounds or greater. For the prevention
of Borrelia burgdorferi infections as a direct result of killing Ixodes
scapularis vector ticks.
* * * * *

0
8. In Sec.  520.2455:
0
a. Revise paragraphs (b)(1) through (4); and
0
b. In paragraph (d)(2), remove ``semduramycin'' and in its place add
``semduramicin.''
    The revisions read as follows:

Sec.  520.2455  Tiamulin.

* * * * *
    (b) * * *
    (1) No. 058198 for products described in paragraph (a) of this
section.
    (2) No. 066104 for product described in paragraph (a)(1) of this
section.
    (3) Nos. 016592, 051311, and 061133 for product described in
paragraph (a)(2) of this section.
    (4) No. 054771 for product described in paragraph (a)(3) of this
section.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 522 continues to read as follows:

    Authority:  21 U.S.C. 360b.

0
10. In Sec.  522.246, revise paragraphs (b)(2) and (3) to read as
follows:

Sec.  522.246  Butorphanol.

* * * * *
    (b) * * *
    (2) No. 043264 for use of the product described in paragraph (a)(2)
of this section as in paragraph (d)(2) of this section.
    (3) Nos. 000061, 043264, and 059399 for use of the product
described in paragraph (a)(3) of this section as in paragraph (d)(3) of
this section.
* * * * *

Sec.  522.533  [Amended]

0
11. In Sec.  522.533, in paragraph (b)(2), remove ``051330'' and in its
place add ``043264''.

0
12. In Sec.  522.690:
0
a. Revise paragraphs (a) and (b);
0
b. Revise paragraph (d)(1) introductory text and paragraph (d)(1)(i);
0
c. Add paragraph (d)(2) introductory text;
0
d. Revise paragraph (d)(2)(ii);
0
e. Add paragraph (d)(3) introductory text;
0
f. Revise paragraph (d)(3)(ii); and
0
g. Remove paragraph (d)(4).
    The revisions and additions read as follows:

Sec.  522.690  Dinoprost.

    (a) Specifications. Each milliliter (mL) of solution contains
dinoprost tromethamine equivalent to:
    (1) 5 milligrams (mg) dinoprost; or
    (2) 12.5 mg dinoprost.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter as
follows:
    (1) Nos. 054771 and 061133 for use of product described in
paragraph (a)(1) as in paragraph (d) of this section.
    (2) No. 054771 for use of product described in paragraph (a)(2) as
in paragraph (d)(1) of this section.
* * * * *
    (d) * * *
    (1) Cattle. Administer products described in paragraph (a) of this
section as follows:
    (i) Amount. 25 mg as an intramuscular injection of the 5 mg/mL
product or as an intramuscular or subcutaneous injection of the 12.5
mg/mL product.
* * * * *
    (2) * * * Administer product described in paragraph (a)(1) of this
section as follows:
* * * * *
    (ii) Indications for use. (A) For controlling the timing of estrus
in estrous cycling mares.
    (B) For difficult-to-breed mares (clinically anestrous mares that
have a corpus luteum).
* * * * *
    (3) * * * Administer product described in paragraph (a)(1) of this
section as follows:
* * * * *
    (ii) Indications for use. For parturition induction in swine.

0
13. In Sec.  522.812, revise paragraph (b)(2) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (2) Nos. 055529, 058005, 058198, and 061133 for use of product
described in paragraph (a)(2) of this section as in paragraphs (e)(2)
and (3) of this section.
* * * * *

Sec.  522.955  [Amended]

0
14. In Sec.  522.955, in paragraph (b)(3), remove ``No. 086050'' and in
its place

add ``Nos. 058005 and 086050''; and in paragraph (d)(1)(ii)(C), remove
``No. 000061'' and in its place add ``Nos. 000061, 058005, and
086050''.

0
15. In Sec.  522.1077, revise paragraph (d)(1)(iv) to read as follows:

Sec.  522.1077  Gonadorelin.

* * * * *
    (d) * * *
    (1) * * *
    (iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this
section as provided by Nos. 054771 and 061133 in Sec.  510.600(c) of
this chapter.
* * * * *

0
16. In Sec.  522.1940, revise the paragraph (c)(1) heading, paragraph
(c)(1)(iii), the paragraph (c)(2) heading, and paragraph (c)(2)(iii) to
read as follows:

Sec.  522.1940  Progesterone and estradiol benzoate.

* * * * *
    (c) * * *
    (1) Suckling beef calves at least 45 days old and up to 400 lb of
body weight--* * *
* * * * *
    (iii) Limitations. For subcutaneous ear implantation, one dose per
animal. Do not use in beef calves less than 45 days of age, dairy
calves, and veal calves because effectiveness and safety have not been
established. Do not use in animals intended for subsequent breeding, or
in dairy cows. A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for veal.
    (2) Growing beef steers weighing 400 lb or more--* * *
* * * * *
    (iii) Limitations. For subcutaneous ear implantation, one dose per
animal. Do not use in beef calves less than 45 days of age, dairy
calves, and veal calves because effectiveness and safety have not been
established. Do not use in animals intended for subsequent breeding, or
in dairy cows. A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for veal.
* * * * *

0
17. In Sec.  522.2343, revise paragraph (c) introductory text and
paragraph (c)(3) to read as follows:

Sec.  522.2343  Testosterone propionate and estradiol benzoate.

* * * * *
    (c) Conditions of use. For implantation in growing beef heifers
weighing 400 lb or more as follows:
* * * * *
    (3) Limitations. For subcutaneous ear implantation, one dose per
animal. Not for use in dairy or beef replacement heifers. Do not use in
beef calves less than 2 months of age, dairy calves, and veal calves
because safety and effectiveness have not been established. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.

0
18. In Sec.  522.2478, redesignate paragraph (d)(3) as paragraph
(d)(4); add new paragraph (d)(3); and revise newly redesignated
paragraph (d)(4) heading and paragraph (d)(4)(i)(C) to read as follows:

Sec.  522.2478  Trenbolone acetate and estradiol benzoate.

* * * * *
    (d) * * *
    (3) Growing beef steers and heifers fed in confinement for
slaughter. (i) For an implant as described in paragraph (a)(2)(ii) of
this section:
    (A) Amount. 150 mg trenbolone acetate and 21 mg estradiol benzoate
in an extended-release implant.
    (B) Indications for use. For increased rate of weight gain for up
to 200 days.
    (C) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant within each separate production phase. Safety
and effectiveness following reimplantation have not been evaluated. Do
not use in beef calves less than 2 months of age, dairy calves, and
veal calves because effectiveness and safety have not been established.
Do not use in beef calves less than 2 months of age, dairy calves, and
veal calves. A withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in dairy cows or in
animals intended for subsequent breeding. Use in these cattle may cause
drug residues in milk and/or in calves born to these cows.
    (ii) [Reserved]
    (4) Growing beef steers and heifers on pasture (stocker, feeder,
and slaughter). (i) * * *
    (C) Limitations. Implant pellets subcutaneously in ear only. Not
approved for repeated implantation (reimplantation) with this or any
other cattle ear implant within each separate production phase. Safety
and effectiveness following reimplantation have not been evaluated. Do
not use in beef calves less than 2 months of age, dairy calves, and
veal calves because effectiveness and safety have not been established.
Do not use in beef calves less than 2 months of age, dairy calves, and
veal calves. A withdrawal period has not been established for this
product in preruminating calves. Do not use in dairy cows or in animals
intended for subsequent breeding. Use in these cattle may cause drug
residues in milk and/or in calves born to these cows.
* * * * *

0
19. In 522.2630, revise paragraphs (b)(1) and (2) to read as follows:

Sec.  522.2630  Tulathromycin.

* * * * *
    (b) * * *
    (1) Nos. 013744, 051311, 054771, 058198, and 061133 for use of
product described in paragraph (a)(1) as in paragraphs (d)(1)(i) and
(ii), (d)(1)(iii)(A), and (d)(2) of this section.
    (2) Nos. 013744, 051311, and 054771 for use of product described in
paragraph (a)(2) as in paragraphs (d)(1)(i), (d)(1)(ii)(B),
(d)(1)(iii)(B), and (d)(2) of this section.
* * * * *

0
20. In Sec.  522.2662, revise paragraph (b)(3) to read as follows:

Sec.  522.2662  Xylazine.

* * * * *
    (b) * * *
    (3) Nos. 043264 and 061651 for use of product described in
paragraph (a)(1) of this section as in paragraph (d)(1) of this
section; and product described in paragraph (a)(2) of this section as
in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this
section.
* * * * *

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
21. The authority citation for part 524 continues to read as follows:

    Authority:  21 U.S.C. 360b.

0
22. In Sec.  524.1146, revise paragraphs (b)(2) and (3) to read as
follows:

Sec.  524.1146  Imidacloprid and moxidectin.

* * * * *
    (b) * * *
    (2) Nos. 051072, 017030, 058198, and 061651 for use of product
described in paragraph (a)(2) of this section as in paragraph (d)(2) of
this section.
    (3) Nos. 051072 and 058198 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(3) of this
section.
* * * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
23. The authority citation for part 529 continues to read as follows:

    Authority:  21 U.S.C. 360b.

0
24. In Sec.  529.1940, revise the last sentence in paragraph
(e)(1)(iii) to read as follows:

Sec.  529.1940  Progesterone intravaginal inserts.

* * * * *
    (e) * * *
    (1) * * *
    (iii) * * * Dinoprost injection for use as in paragraphs
(e)(1)(ii)(A) and (B) of this section as in Sec.  522.690 of this
chapter, provided by Nos. 054771 and 061133 in Sec.  510.600(c) of this
chapter.
* * * * *

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
25. The authority citation for part 556 continues to read as follows:

    Authority:  21 U.S.C. 342, 360b, 371.

0
26. In 556.240, revise paragraphs (b)(1) and (c) to read as follows:

Sec.  556.240  Estradiol and related esters.

* * * * *
    (b) * * *
    (1) Cattle. (i) Muscle: 0.2 ppb.
    (ii) Liver: 0.6 ppb.
    (iii) Kidney: 1.2 ppb.
    (iv) Fat: 1.2 ppb.
* * * * *
    (c) Related conditions of use. See Sec. Sec.  522.840, 522.850,
522.1940, 522.2343, 522.2477, and 522.2478 of this chapter.

0
27. In Sec.  556.370, revise paragraph (b) to read as follows:

Sec.  556.370  Lubabegron.

* * * * *
    (b) Tolerances. The tolerances for lubabegron (marker residue) are:
    (1) Cattle. (i) Liver (target tissue): 10 ppb.
    (ii) Muscle: 3 ppb.
    (iii) Kidney: 20 ppb.
    (2) [Reserved]
* * * * *

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
28. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
29. In Sec.  558.254, revise paragraph (e) to read as follows:

Sec.  558.254  Famphur.

* * * * *
    (e) Conditions of use. It is used in cattle feed as follows:

----------------------------------------------------------------------------------------------------------------
            Famphur amount                    Indications for use                 Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
(1) To provide 1.1 milligrams per       Beef cattle and nonlactating    Feed for 30 days. Withdraw        000061
 pound (mg/lb) body weight per day.      dairy cattle: For control of    from dry dairy cows and
                                         grubs and as an aid in          heifers 21 days prior to
                                         control of sucking lice.        freshening. Withdraw 4 days
                                                                         prior to slaughter.
(2) To provide 2.3 mg/lb body weight    Beef cattle and nonlactating    Feed for 10 days. Withdraw        000061
 per day.                                dairy cattle: For control of    from dry dairy cows and
                                         grubs.                          heifers 21 days prior to
                                                                         freshening. Withdraw 4 days
                                                                         prior to slaughter.
----------------------------------------------------------------------------------------------------------------

0
30. In Sec.  558.355, revise paragraphs (d)(8)(vi) and (f)(1)(ii),
(iv), and (vi) to read as follows:

Sec.  558.355  Monensin.

* * * * *
    (d) * * *
    (8) * * *
    (vi) Not for replacement chickens intended to become broiler
breeding chickens.
* * * * *
    (f) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                            Combination in grams/
   Monensin in grams/ton             ton             Indications for use            Limitations          Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(ii) 90 to 110............                        Layer replacement          Feed continuously as the     058198
                                                   chickens: As an aid in     sole ration. Do not feed
                                                   the prevention of          to chickens over 16
                                                   coccidiosis caused by E.   weeks of age. Do not
                                                   necatrix, E. tenella, E.   feed to laying chickens.
                                                   acervulina, E. brunetti,
                                                   E. mivati, and E. maxima.

                                                  * * * * * * *
(iv) 90 to 110............  Bacitracin            Layer replacement          Feed continuously as sole    054771
                             methylenedisalicyla   chickens: As an aid in     ration. Do not feed to
                             te, 4 to 50.          the prevention of          chickens over 16 weeks
                                                   coccidiosis caused by E.   of age. Do not feed to
                                                   necatrix, E. tenella, E.   laying chickens.
                                                   acervulina, E. brunetti,   Monensin sodium provided
                                                   E. mivati, and E.          by No. 058198,
                                                   maxima, and for            bacitracin
                                                   increased rate of weight   methylenedisalicylate
                                                   gain and improved feed     provided by No. 054771
                                                   efficiency.                in Sec.   510.600(c) of
                                                                              this chapter.

                                                  * * * * * * *
(vi) 90 to 110............  Bacitracin            Broiler and layer          Feed continuously as sole    054771
                             methylenedisalicyla   replacement chickens: As   ration. Do not feed to
                             te, 50.               an aid in the prevention   chickens over 16 weeks
                                                   of coccidiosis caused by   of age. Do not feed to
                                                   E. necatrix, E. tenella,   laying chickens.
                                                   E. acervulina, E.          Monensin sodium provided
                                                   brunetti, E. mivati, and   by No. 058198,
                                                   E. maxima, and for         bacitracin
                                                   improved feed              methylenedisalicylate
                                                   efficiency, and as an      provided by No. 054771
                                                   aid in the prevention of   in Sec.   510.600(c) of
                                                   necrotic enteritis         this chapter.
                                                   caused or complicated by
                                                   Clostridium spp. or
                                                   other organisms
                                                   susceptible to
                                                   bacitracin.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
31. In Sec.  558.500, revise paragraphs (b) and (e)(2)(i), (iii), and
(vi) to read as follows:

Sec.  558.500  Ractopamine.

* * * * *
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this
chapter.
    (1) No. 058198: Type A medicated articles containing 9 or 45.4
grams per pound (g/lb) ractopamine hydrochloride.

    (2) Nos. 016592, 051311, and 054771: Type A medicated articles
containing 45.4 g/lb ractopamine hydrochloride.
* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combination in grams/
    Ractopamine in grams/ton              ton             Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8.2 to 24.6................                         Cattle fed in           Feed continuously as      016592
                                                         confinement for         sole ration during       051311
                                                         slaughter: For          the last 28 to 42        054771
                                                         increased rate of       days on feed. Not for    058198
                                                         weight gain and         animals intended for
                                                         improved feed           breeding.
                                                         efficiency during the
                                                         last 28 to 42 days on
                                                         feed.

                                                  * * * * * * *
(iii) 9.8 to 24.6..............                         Cattle fed in           Feed continuously as      016592
                                                         confinement for         sole ration during       051311
                                                         slaughter: For          the last 28 to 42        054771
                                                         increased rate of       days on feed. Not for    058198
                                                         weight gain, improved   animals intended for
                                                         feed efficiency, and    breeding.
                                                         increased carcass
                                                         leanness during the
                                                         last 28 to 42 days on
                                                         feed.

                                                  * * * * * * *
(vi) Not to exceed 800; to       .....................  Cattle fed in           Top dress ractopamine     016592
 provide 70 to 400 mg/head/day.                          confinement for         at a minimum of 1.0      051311
                                                         slaughter: For          lb/head/day of           054771
                                                         increased rate of       medicated feed           058198
                                                         weight gain and         continuously during
                                                         improved feed           the last 28 to 42
                                                         efficiency during the   days on feed. Not for
                                                         last 28 to 42 days on   animals intended for
                                                         feed.                   breeding..

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

Sec.  558.555  [Amended]

0
32. In Sec.  558.555, in paragraph (f), remove ``Semduramycin'' and in
its place add ``Semduramicin''.

0
33. In Sec.  558.633, revise paragraph (d)(3) to read as follows:

Sec.  558.633  Tylvalosin.

* * * * *
    (d) * * *
    (3) Pelleted Type C medicated feeds must bear an expiration date of
30 days after the date of manufacture. Crumbled Type C medicated feeds
must bear an expiration date of 7 days after the date of manufacture.
* * * * *

0
34. In Sec.  558.680, revise paragraphs (d)(1)(iii), (iv), (vii), and
(viii) and (d)(2) to read as follows:

Sec.  558.680  Zoalene.

* * * * *
    (d) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                 Combination in grams/
      Zoalene in grams/ton                ton             Indications for use         Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(iii) 36.3 to 113.5............  Bacitracin             Replacement chickens:   Feed continuously as      054771
                                  methylenedisalicylat   For development of      the sole ration as in    058198
                                  e, 50.                 active immunity to      the subtable in item
                                                         coccidiosis; and as     (i). Grower ration
                                                         an aid in the control   not to be fed to
                                                         of necrotic enteritis   birds over 14 weeks
                                                         caused or complicated   of age. Bacitracin
                                                         by Clostridium spp.     methylenedisalicylate
                                                         or other organisms      as provided by No.
                                                         susceptible to          054771 in Sec.
                                                         bacitracin.             510.600(c) of this
                                                                                chapter.
(iv) 36.3 to 113.5.............  Bacitracin             Replacement chickens:   Feed continuously as      054771
                                  methylenedisalicylat   For development of      sole ration as in the    058198
                                  e, 100 to 200.         active immunity to      subtable in item (i).
                                                         coccidiosis; and as     To control necrotic
                                                         an aid in the control   enteritis, start
                                                         of necrotic enteritis   medication at first
                                                         caused or complicated   clinical signs of
                                                         by Clostridium spp.     disease; vary
                                                         or other organisms      bacitracin dosage
                                                         susceptible to          based on the severity
                                                         bacitracin.             of infection;
                                                                                administer
                                                                                continuously for 5 to
                                                                                7 days or as long as
                                                                                clinical signs
                                                                                persist, then reduce
                                                                                bacitracin to
                                                                                prevention level (50
                                                                                g/ton). Bacitracin
                                                                                methylenedisalicylate
                                                                                as provided by No.
                                                                                054771 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.

                                                  * * * * * * *
(vii) 113.5....................  Bacitracin             Broiler chickens: For   Feed continuously as      054771
                                  methylenedisalicylat   prevention and          the sole ration.         058198
                                  e, 50.                 control of              Bacitracin
                                                         coccidiosis; and as     methylenedisalicylate
                                                         an aid in the           as provided by No.
                                                         prevention of           054771 in Sec.
                                                         necrotic enteritis      510.600(c) of this
                                                         caused or complicated   chapter.
                                                         by Clostridium spp.
                                                         or other organisms
                                                         susceptible to
                                                         bacitracin.
(viii) 113.5...................  Bacitracin             Broiler chickens: For   Feed continuously as      054771
                                  methylenedisalicylat   prevention and          sole ration. To          058198
                                  e,.                    control of              control necrotic
                                 100 to 200...........   coccidiosis; and as     enteritis, start
                                                         an aid in the control   medication at first
                                                         of necrotic enteritis   clinical signs of
                                                         caused or complicated   disease; vary
                                                         by Clostridium spp.     bacitracin dosage
                                                         or other organisms      based on the severity
                                                         susceptible to          of infection;
                                                         bacitracin.             administer
                                                                                continuously for 5 to
                                                                                7 days or as long as
                                                                                clinical signs
                                                                                persist, then reduce
                                                                                bacitracin to
                                                                                prevention level (50
                                                                                g/ton). Bacitracin
                                                                                methylenedisalicylate
                                                                                as provided by No.
                                                                                054771 in Sec.
                                                                                510.600(c) of this
                                                                                chapter.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
     Zoalene in grams/ton           grams/ton          Indications for use           Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5 to 170.3...........                       Growing turkeys: For      Feed continuously as        054771
                                                     prevention and control    sole ration. For           058198
                                                     of coccidiosis.           turkeys grown for meat
                                                                               purposes only. Not to
                                                                               be fed to laying birds.
(ii) 113.5 to 170.3..........  Bacitracin           Growing turkeys: For      Feed continuously as        054771
                                methylenedisalicyl   prevention and control    sole ration until 14 to    058198
                                ate, 4 to 50.        of coccidiosis; and for   16 weeks of age. For
                                                     increased rate of         turkeys grown for meat
                                                     weight gain and           purposes only. Not to
                                                     improved feed             be fed to laying birds.
                                                     efficiency.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: March 21, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs,
U.S. Food and Drug Administration.
[FR Doc. 2022-06395 Filed 3-28-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 5, 2010 (Volume 75, Number 192)]
[Notices]
[Page 61483-61485]
[DOCID:fr05oc10-95]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-AO-2010-EPA-HQ-AO-2010-0739 FRL-9210-4]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Regulatory Pilot Projects (Renewal); EPA ICR No.
1755.09; OMB Control No. 2010-0026

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on March 31, 2011. Before submitting the ICR to OMB
for review and approval, EPA is soliciting comments on specific aspects
of the proposed information collection as described below.

DATES: Comments must be submitted on or before December 6, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-AO-
2010-0739 by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: OA Docket, EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460.
     Hand Delivery: Office of the Administrator Docket in the
EPA Docket Center (EPA/DC), EPA West, Room

3334, 1301 Constitution Avenue, NW, Washington, DC.
    Such deliveries are only accepted during the Docket's normal hours
of operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-AO-2010-
0739 EPA's policy is that all comments received will be included in the
public docket without change and may be made available online at http:/
/www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-
mail. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://
www.regulations.gov your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Gerald Filbin, Office of Policy
(1807T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
566-2220; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How can i access the docket and/or submit comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-AO-2010-0739 which is available for online viewing at http:/
/www.regulations.gov, or in person viewing at the Office of the
Administrator Docket in the EPA Docket Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Reading
Room is<PHONE_NUMBER>, and the telephone number for the Office of the
Administrator Docket is<PHONE_NUMBER>.
    Use www.regulations.gov to obtain a copy of the draft collection of
information, submit or view public comments, access the index listing
of the contents of the docket, and to access those documents in the
public docket that are available electronically. Once in the system,
select ``search,'' then key in the docket ID number identified in this
document.

What information is EPA interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What should i consider when i prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What information collection activity or ICR does this apply to?

    Affected Entities: Entities potentially affected by this action are
primarily state environmental agencies that have received EPA State
Innovation Grants in the seven (7) competitions that occurred from
2002-2009 that must report to EPA on their performance on those
assistance agreements. In some cases this means that these state
environmental agencies must gather and report on aspects of
environmental performance from multiple regulated facilities
participating in funded projects. State Agencies with State innovation
Grant Assistance Agreements must report their progress to EPA on a
quarterly basis and for the preparation of project final reports.
Twenty (20) of the thirty-nine (39) projects funded under the program
remain active. These state environmental agencies request performance
information from facilities participating in or whose participation is
being solicited for pilot projects to test innovation in environmental
permitting. Other parties affected by this request may include
industrial facilities and state agencies that have been participants in
Project XL in circumstances where projects are being completed or
terminated and information characterizing the outcomes of those
projects is being sought by EPA to close out those individual projects.
In addition, state environmental agencies that wish to respond to a
request for consultation with EPA on innovative practices that may be
pilot tested and evaluated to better address emerging environmental
issues (e.g., climate change adaptation) may be affected.
    Title: Regulatory Reinvention Pilots (Renewal).
    ICR Numbers: EPA ICR No. 1755.09, OMB Control No. 2010-0026.
    ICR Status: This ICR is currently scheduled to expire on March 31,
2011. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control

number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register when approved, are
listed in 40 CFR part 9, are displayed either by publication in the
Federal Register or by other appropriate means, such as on the related
collection instrument or form, if applicable. The display of OMB
control numbers in certain EPA regulations is consolidated in 40 CFR
part 9.
    Abstract: This is an information collection request renewal that
will allow for the continued information collection related to
innovative pilot projects conducted under EPA's project XL and State
Innovation grant Programs and to allow EPA and state environmental
agencies supported under cooperative agreements for these programs to
continue their commitments to monitor the results of remaining pilot
tests of regulatory innovation initiated under these programs. While
both the EPA State Innovation Grant Program and Project XL no longer
accept new project proposals or initiate new projects, the renewal of
this ICR is important as it will allow the Agency to continue to assess
performance outcomes of remaining regulatory innovation piloting
projects and to identify the broader applicability of those pilot
projects. Both Project XL and the State Innovation Grant Program have
stopped accepting new innovation project proposals but states
implementing existing innovative regulatory pilot tests in projects
funded by a State Innovation Grant are required to report on progress
during the operation of a project and to provide a final project report
summarizing outcomes and major findings of each project. EPA's policy
on performance measurement in assistance agreements is an
implementation outcome under the Government Performance and Results Act
(GPRA Sec.  1115 (a)(4) and Sec.  1116(c)). EPA's innovation piloting
efforts are multi-media in nature and include programs authorized under
the full range of authorizing legislation (e.g., the Clean Air Act,
Section 103(b)(3) (42 U.S.C. 7403(b)(3)) the Clean Water Act, Section
104(b)(3) (33 U.S.C. 1254(b)(3)); the Solid Waste Disposal Act, Section
8001 (42 U.S.C. 6981); the Toxic Substances Control Act, Section 10 (15
U.S.C. 2609); the Federal Insecticide, Fungicide, and Rodenticide Act,
Section 20 (7 U.S.C. 136r); and the Safe Drinking Water Act, Sections
1442 (a) and (c) (42 U.S.C. 1(a) and (c)).
    Responses related to the grant program are required to achieve the
quarterly and final project reporting stipulated in the grant awards.
Responses related to Project XL are voluntary. EPA remains interested
in collaborating with states, tribes and localities for the purpose of
testing and evaluating innovative practices, both regulatory and
voluntary that lead to better environmental results, particularly as
they apply to emerging environmental issues. The measurement of results
in these pilot tests and the evaluation of success, efficiency, and
broader application are key to EPA's interest in producing better
environmental results through innovation.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 100
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential annual respondents: 20.
    Frequency of response: 20 quarterly; 85 annually.
    Estimated total average number of responses for each respondent:
4.1.
    Estimated total annual burden hours: 4820.
    Estimated total annual costs: $367,131. This includes an estimated
burden cost of $367,131 and an estimated cost of $0 for capital
investment or maintenance and operational costs.

Are there changes in the estimates from the last approval?

    There is an increase of 318 hours in the total estimated respondent
burden compared with that identified in the ICR currently approved by
OMB. This reflects the need to collect information on project
performance and outcomes in the form of quarterly reporting and final
project reporting for current projects only not addressed in other
ICRs.

What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: September 27, 2010.
Elizabeth A. Shaw,
Director, Office of Strategic Environmental Management.
[FR Doc. 2010-24926 Filed 10-4-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 24 (Thursday, February 5, 2015)]
[Notices]
[Pages 6563-6565]
[FR Doc No: 2015-02252]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74180; File No. SR-NYSEMKT-2015-07]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending the NYSE Amex
Options Fee Schedule To Make a Change to the Amex Customer Engagement
Program in Section I.E. of the Fee Schedule

January 30, 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 January 28, 2015, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. 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 Substance
of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Amex Options Fee Schedule
(``Fee Schedule'') to make a change to the Amex Customer Engagement
(``ACE'') Program in section I.E. of the Fee Schedule. The Exchange
proposes to implement the change on February 2, 2015. The text of the
proposed rule change is available on the Exchange's Web site at
www.nyse.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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to make a change to the ACE Program in
section I.E. of the Fee Schedule. The Exchange proposes to implement
the change on February 2, 2015.
    Section I.E. of the Fee Schedule describes the ACE Program,\3\
which features four tiers expressed as a percentage of total industry
Customer equity and ETF option average daily volume (``ADV'').\4\
Specifically, the ACE Program consists of a four-tiered schedule of per
contract credits payable to an Order Flow Provider (``OFP'') solely for
Electronic Customer volume that the OFP, as agent, submits to the
Exchange.\5\ The ACE Program offers the following two methods for OFPs
to receive credits:
---------------------------------------------------------------------------

    \3\ See NYSE Amex Options Fee Schedule, dated January 14, 2015,
available here, https://www.theice.com/publicdocs/nyse/markets/amex-options/NYSE_Amex_Options_Fee_Schedule.pdf.
    \4\ In calculating ADV, the Exchange will utilize monthly
reports published by the OCC for equity options and ETF options that
show cleared volume by account type. See OCC Monthly Statistics
Reports, available here, http://www.theocc.com/webapps/monthly-volume-reports (including for equity options and ETF options volume,
subtotaled by exchange, along with OCC total industry volume). The
Exchange will calculate the total OCC volume for equity and ETF
options that cleared in the Customer account type and divide this
total by the number of trading days for that month (i.e., any day
the Exchange is open for business). For example, in a month having
21 trading days where there were 252,000,000 equity option and ETF
option contracts that cleared in the Customer account type, the
calculated ADV would be 12,000,000 (252,000,000/21 = 12,000,000).
    \5\ Electronic Customer volume is volume executed electronically
through the Exchange System, on behalf of an individual or
organization that is not a Broker-Dealer and who does not meet the
definition of a Professional Customer.
---------------------------------------------------------------------------

    1. By calculating, on a monthly basis, the average daily Customer
contract volume an OFP executes Electronically on the Exchange as a
percentage of total industry Customer equity and ETF options ADV; \6\
or
---------------------------------------------------------------------------

    \6\ See supra n. 4.
---------------------------------------------------------------------------

    2. By calculating, on a monthly basis, the average daily contract
volume an OFP executes Electronically in all participant types (i.e.,
Customer, Firm, Broker-Dealer, NYSE Amex Options Market Maker, Non-NYSE
Amex Options Market Maker, and Professional Customer) on the Exchange,
as a percentage of total industry Customer equity and ETF options
ADV,\7\ of which at least 20% must be Customer volume executed
Electronically.
---------------------------------------------------------------------------

    \7\ Id.
---------------------------------------------------------------------------

    The Exchange has received questions regarding qualification for
credits under

method 2 of the ACE Program and proposes changes to the level of
Customer volume required to qualify for credits under method 2.
Specifically, the Exchange proposes to revise method 2 by replacing the
clause ``of which at least 20% must be Customer volume executed
Electronically'' with the clause ``with the further requirement that a
specified percentage of the minimum volume required to qualify for the
Tier must be Customer volume.'' \8\ In addition, proposed language
changes are shown in the table below, with underlining used to denote
new language.
---------------------------------------------------------------------------

    \8\ As proposed, an OFP qualifies for credits under method 2
``[b]y calculating, on a monthly basis, the average daily contract
volume an OFP executes Electronically in all participant types
(i.e., Customer, Firm, Broker-Dealer, NYSE Amex Options Market
Maker, Non-NYSE Amex Options Market Maker, and Professional
Customer) on the Exchange, as a percentage of total average daily
industry Customer equity and ETF option volume, with the further
requirement that a specified percentage of the minimum volume
required to qualify for the Tier must be Customer volume.''

                                                   Amex Customer Engagement Program--Standard Options
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       ACE program--Standard options                       Credits payable on customer volume only
                                        ----------------------------------------------------------------------------------------------------------------
                                                                          Total electronic ADV (of
                                                                          which 20% or greater of
                  Tier                    Customer electronic ADV          the minimum volume for                      1 year enhanced   3 year enhanced
                                             as a % of industry      OR      each tier must be       Customer volume   customer volume   customer volume
                                          customer equity and ETF           customer) as a % of          credits           credits           credits
                                                options ADV               industry customer equity
                                                                            and ETF options ADV
--------------------------------------------------------------------------------------------------------------------------------------------------------
1......................................  0.00% to 0.75%...........  ...  N/A......................           $0.00             $0.00             $0.00
2......................................  >0.75% to 1.00%..........  ...  N/A......................          ($0.13)           ($0.13)           ($0.13)
3......................................  >1.00% to 2.00%..........  ...  1.50% to 3.50% of which            ($0.14)           ($0.16)           ($0.18)
                                                                          20% or greater of 1.50%
                                                                          must be Customer.
4......................................  >2.00%...................  ...  >3.50% of which 20% or             ($0.14)           ($0.16)           ($0.20)
                                                                          greater of 3.5% must be
                                                                          Customer.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The Exchange's current Fee Schedule requires, under method 2 for
qualifying for the credits under the ACE Program, that at least 20% of
an OFP's Electronic volume \9\ be comprised of Customer volume.
However, because method 2 does not fix the 20% Customer volume
requirement at a specified, minimum level, the more volume that an OFP
executes, the more Customer volume required to qualify for credits
under method 2. This condition to receiving ACE Program credits under
method 2 could create the unintended incentive for an OFP that has a
proportional reduction in its Customer volume (i.e., if its overall
volume of Non-Customer increases, but its Customer volume does not) to
reduce its trading of Non-Customer Electronic volume on the Exchange in
order to satisfy the 20% Customer volume condition and receive the
credits available under method 2.
---------------------------------------------------------------------------

    \9\ The Fee Schedule describes how the Exchange calculates an
OFP's Electronic volume for purposes of the ACE Program. See Section
I.E of the Fee Schedule. In particular, ``the Exchange will exclude
volume resulting from Mini Options and QCC trades;'' and will
likewise exclude ``any volume attributable to orders routed to
another exchange in connection with the Options Order Protection and
Locked/Crossed Market Plan referenced in Rule 991NY.'' The Exchange
will include in its calculation of an OFP's Electronic volume for
purposes of the ACE Program, ``[v]olume resulting from CUBE Auction
executions'' and ``will include the activity of Affiliates [i.e.,
entities with 70% common ownership] of the OFP, such as when an OFP
has an Affiliated NYSE Amex Options Market Making firm.'' Id. The
Exchange notes that any day the Exchange is open, regardless of
length, will count as a full day when calculating ADV.
---------------------------------------------------------------------------

    To avoid the potential that the 20% Customer volume requirement
could induce OFPs to reduce their activity on the Exchange to avoid
disqualifying themselves for potential credits under method 2 of the
ACE Program, the Exchange proposes to modify method 2 to specify that
the Customer volume component for each Tier is 20% of the minimum
volume for that Tier. Specifically, as proposed, to qualify for credits
under Tier 3, an OFP's Customer volume would have to be at least 20% of
volume required to satisfy the 1.50% of total average daily industry
Customer equity and ETF option volume that an OFP must execute
Electronically on the Exchange.\10\ Similarly, as proposed, to qualify
for Tier 4, an OFP's Customer volume would have to be 20% of volume
required to satisfy the 3.50% of total average daily industry Customer
equity and ETF option volume that an OFP must execute Electronically on
the Exchange.\11\
---------------------------------------------------------------------------

    \10\ An OFP's Customer volume would need to be 0.3% (i.e., 1.50%
x 20%) of the total average daily industry Customer equity and ETF
option volume.
    \11\ An OFP's Customer volume would need to be 0.7% (i.e., 3.50%
x 20%) of the total average daily industry Customer equity and ETF
option volume.
---------------------------------------------------------------------------

    For example, as noted above,\12\ in a month having 21 trading days
where the OCC reported 252,000,000 equity and ETF option contracts
clearing in the Customer range, the calculated ADV is 12,000,000
(252,000,000/21 = 12,000,000). The ACE Program tiers are based on the
ADV an OFP executes Electronically on the Exchange. Under method 2, the
ADV associated with Tier 3 credits ranges from 1.5% to 3.5% of industry
Customer equity option and ETF option ADV (1.5% of 12,000,000 = 180,000
and 3.5% of 12,000,000 = 420,000). Under the current Fee Schedule, to
qualify for the Tier 3 credits, an OFP with total Electronic ADV of
180,000 contracts would be required to have at least 20% of that
volume, or 36,000 contracts (20% of 180,000 = 36,000) conducted as
Customer. However, an OFP that has total electronic ADV of 420,000
contracts would be required to have at least 84,000 contracts (20% of
420,000 = 84,000) as Customer volume to qualify for Tier 3 credits.
---------------------------------------------------------------------------

    \12\ See supra n. 4.
---------------------------------------------------------------------------

    As proposed, to qualify for Tier 3 credits, both OFPs in the above
example would be required to have 36,000 contracts as Customer volume.
In other words, Tier 3 credits would be available to any OFP with total
Electronic ADV of between 1.50% and 3.50% of Industry Customer Equity
and ETF Options ADV, provided that the OFP conducted at least 0.3% of
industry Customer equity and ETF option ADV as Customer volume (1.50%
of 12,000,000 = 180,000 and 20% of 180,000 = 36,000, which is the same
as 0.3% of 12,000,000 = 36,000). Continuing the example, under the
proposed change, an OFP with total electronic ADV greater than 3.5% of
industry Customer equity option and

ETF option ADV would qualify for the Tier 4 credits provided the OFP
also had Customer ADV of at least 0.7% of Industry Customer equity and
ETF option ADV (3.50% of 12,000,000 = 420,000 and 20% of 420,000 =
84,000, which is the same as 0.7% of 12,000,000 = 84,000).
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Securities Exchange Act of 1934 (the
``Act''),\13\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\14\ in particular, because it would
provide for the equitable allocation of reasonable dues, fees, and
other charges among its members, issuers and other persons using its
facilities and does not unfairly discriminate between customers,
issuers, brokers or dealers.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(4) and 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that specifying a minimum volume amount to
meet the 20% Customer volume component for each Tier under method 2 of
the ACE Program is reasonable, equitable and not unfairly
discriminatory because it is designed to reduce the potential that OFPs
divert Non-Customer order flow away from the Exchange, which may
increase volume and liquidity on the Exchange to the benefit of all
market participants by providing tighter quoting and better prices, all
of which perfects the mechanism for a free and open market and national
market system. The Exchange believes that the proposal is not unfairly
discriminatory as it applies equally to all OFPs, enabling each OFP to
qualify under method 2 of the ACE Program upon achieving a set minimum
threshold for Customer volume based on ADV. The Exchange also believes
that the proposal is reasonable, equitable and not unfairly
discriminatory because specifying a minimum volume amount to meet the
20% Customer volume component for each Tier under method 2 of the ACE
Program would add clarity to the Fee Schedule and aid in market
participants' comprehension as to how to qualify for the credits under
the ACE Program.

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the ACE Program will continue to encourage Customer order flow to be
directed to the Exchange. By incentivizing OFPs to route Customer
orders, the Exchange desires to attract liquidity to the Exchange,
which in turn benefits all market participants.
    Given the robust competition for volume among options markets, many
of which offer the same products, implementing programs to attract
order flow similar to the one being proposed in this filing, are
consistent with the above-mentioned goals of the Act. The Exchange
notes that it operates in a highly competitive market in which market
participants can readily favor competing venues. In such an
environment, the Exchange must continually review, and consider
adjusting, its fees and credits to remain competitive with other
exchanges. For the reasons described above, the Exchange believes that
the proposed rule change reflects this competitive environment.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \15\ of the Act and subparagraph (f)(2) of Rule
19b-4 \16\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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 under
Section 19(b)(2)(B) \17\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSEMKT-2015-07 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2015-07. 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 offices 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-NYSEMKT-2015-
07, and should be submitted on or before February 26, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-02252 Filed 2-4-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Notices]
[Pages 76455-76456]
[FR Doc No: 2010-30754]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL11-6-000]

Alta Wind I, LLC; Notice of Petition for Declaratory Order

December 1, 2010.
    Take notice that on November 19, 2010, Alta Wind I, LLC filed a
Petition for Declaratory Order requesting that the Federal Energy
Regulatory Commission (Commission) disclaim jurisdiction, under section
201 of the Federal Power Act, over owner lessors and owner participants
associated with a sale and leaseback transaction related to a
generation project under development.

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 8, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-30754 Filed 12-7-10; 8:45 am]
BILLING CODE 6717-01-P