[Federal Register Volume 86, Number 213 (Monday, November 8, 2021)]
[Rules and Regulations]
[Pages 61682-61687]
[FR Doc No: 2021-24075]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsor Address

AGENCY: Food and Drug Administration, (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 April, May, and June 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
and readability of the regulations.

DATES: This rule is effective November 8, 2021.

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 April, May, and June 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 April, May, and June 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
       Approval date        File No.         Sponsor              Product name              Species          Effect of the action    Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 5, 2021.............   200-697  Accord Healthcare,     Enrofloxacin           Dogs..................  Original approval as   FOI Summary.
                                       Inc., 1009 Slater      Injectable Solution                            a generic copy of
                                       Rd., Suite 210-B,      2.27%.                                         NADA 140-913.
                                       Durham, NC 27703.

April 12, 2021............   141-528  Elanco US Inc., 2500   CREDELIO CAT           Cats..................  Supplemental approval  FOI Summary.
                                       Innovation Way,        (lotilaner) Chewable                           for treatment and
                                       Greenfield, IN 46140.  Tablets.                                       control of black-
                                                                                legged tick
                                                                                infestations for one
                                                                                month in cats and
                                                                                kittens.
April 23, 2021............   200-702  Cronus Pharma          Amoxicillin and        Dogs and cats.........  Original approval as   FOI Summary.
                                       Specialties India      Clavulanate                                    a generic copy of
                                       Private Ltd., Sy No-   Potassium Tablets.                             NADA 055-099.
                                       99/1, M/s GMR
                                       Hyderabad Aviation
                                       SEZ Ltd.,
                                       Mamidipalli Village,
                                       Shamshabad Mandal,
                                       Ranga Reddy,
                                       Hyderabad,
                                       Telangana, 501218,
                                       India.
April 26, 2021............   139-189  Intervet, Inc., 2      SAFE-GUARD             Cattle................  Supplemental approval  FOI Summary.
                                       Giralda Farms,         (fenbendazole) Type                            providing for a
                                       Madison, NJ 07940.     C free-choice                                  tolerance and tissue
                                                              medicated feed                                 withdrawal periods
                                                              blocks.                                        in accordance with a
                                                                                repartitioning of
                                                                                the acceptable daily
                                                                                intake (ADI); and
                                                                                the addition of
                                                                                indications for
                                                                                4th[dash]stage
                                                                                larval forms of
                                                                                certain
                                                                                endoparasites.
May 18, 2021..............   141-452  Zoetis Inc., 333       SIMPARICA (sarolaner)  Dogs..................  Supplemental approval  FOI Summary.
                                       Portage St.,           Chewables.                                     for the prevention
                                       Kalamazoo, MI 49007.                                                  of Borrelia
                                                                                burgdorferi
                                                                                infection as a
                                                                                direct result of
                                                                                killing Ixodes
                                                                                scapularis vector
                                                                                ticks.
May 26, 2021..............   140-269  Do...................  KETOFEN (ketoprofen)   Cattle................  Supplemental approval  FOI Summary.
                                                              Injectable Solution.                           for control of
                                                                                pyrexia associated
                                                                                with bovine
                                                                                respiratory disease
                                                                                (BRD) and
                                                                                establishing a
                                                                                tolerance for
                                                                                residues of
                                                                                ketoprofen in edible
                                                                                tissues of cattle.
June 1, 2021..............   141-543  Do...................  DRAXXIN KP             Cattle................  Original approval for  FOI Summary.
                                                              (tulathromycin and                             the treatment of
                                                              ketoprofen)                                    bovine respiratory
                                                              Injectable Solution.                           disease (BRD) and
                                                                                control of pyrexia
                                                                                associated with BRD
                                                                                in certain classes
                                                                                of cattle.
June 10, 2021.............   200-700  Chanelle               PARASEDGE Multi for    Dogs..................  Original approval as   FOI Summary.
                                       Pharmaceuticals        Dogs (imidacloprid                             a generic copy of
                                       Manufacturing Ltd.,    and moxidectin)                                NADA 141-234.
                                       Loughrea, County       Topical Solution.
                                       Galway, Ireland.
June 10, 2021.............   200-701  Do...................  PARASEDGE Multi for    Cats..................  Original approval as   FOI Summary.
                                                              Cats (imidacloprid                             a generic copy of
                                                              and moxidectin)                                NADA 141-254.
                                                              Topical Solution.
June 14, 2021.............   128-620  Intervet, Inc., 2      SAFE-GUARD             ......................  Supplemental approval  FOI Summary.
                                       Giralda Farms,         (fenbendazole)                                 to establish a milk
                                       Madison, NJ 07940.     Suspension.                                    discard time in
                                                                                cattle and a goat
                                                                                tissue tolerance in
                                                                                accordance with
                                                                                repartitioning of
                                                                                the ADI.
June 14, 2021.............   200-704  Felix Pharmaceuticals  Deracoxib Chewable     Dogs..................  Original approval as   FOI Summary.
                                       PVT Ltd., 25-28        Tablets.                                       a generic copy of
                                       North Wall Quay,                                                      NADA 141-203.
                                       Dublin, 1, Ireland.
June 28, 2021.............   200-706  Do...................  Carprofen Chewable     Dogs..................  Original approval as   FOI Summary.
                                                              Tablets.                                       a generic copy of
                                                                                NADA 141-111.
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II. Change of Sponsor's Address

    Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510
has informed FDA that it has changed its address to 121 Seaport Blvd.,
Boston, MA 02210.
    Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN
55126-2910 has informed FDA that it has changed its address to 4001
Lexington Ave., North Arden Hills, MN 55126-2910.

III. Technical Amendments

    FDA is making the following amendment to improve the accuracy of
the animal drug regulations:
     21 CFR 520.304 is amended to reflect the currently
approved strengths of carprofen chewable tablets.
     21 CFR part 522 is amended to organize sections for
injectable pentobarbital drugs by their titles in alphabetic sequence.
     21 CFR 558.128 is amended to add introductory text
identifying the paragraph for medicated cattle feeds containing
chlortetracycline.
     21 CFR 558.355 is amended to add introductory text
identifying the paragraph for medicated cattle feeds containing
monensin.

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 Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

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, 520, 522, 524, 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), revise the entries for ``Alexion
Pharmaceuticals, Inc.'' and ``Purina Animal Nutrition LLC;'' and
0
b. In the table in paragraph (c)(2), revise the entries for ``017800''
and ``069334''.
    The revisions 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
------------------------------------------------------------------------

                              * * * * * * *
Alexion Pharmaceuticals, Inc., 121 Seaport Blvd.,                 069334
 Boston, MA 02210.......................................

                              * * * * * * *
Purina Animal Nutrition LLC, 4001 Lexington Ave., North           017800
 Arden Hills, MN 55126-2910.............................

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

    (2) * * *

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

                              * * * * * * *
017800...................  Purina Animal Nutrition LLC, 4001 Lexington
                            Ave., North Arden Hills, MN 55126-2910.

                              * * * * * * *
069334...................  Alexion Pharmaceuticals, Inc., 121 Seaport
                            Blvd., Boston, MA 02210.

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

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
4. In Sec.  520.88g, revise paragraph (b)(2) to read as follows:

Sec.  520.88g  Amoxicillin trihydrate and clavulanate potassium
tablets.

* * * * *
    (b) * * *
    (2) Nos. 026637 and 069043 for use of tablets as in paragraph (c)
of this section.
* * * * *

0
5. In Sec.  520.304, revise paragraph (b)(2) to read as follows:

Sec.  520.304  Carprofen.

* * * * *
    (b) * * *
    (2) Nos. 058198 and 086101 for use of product described in
paragraph (a)(2) as in paragraph (c) of this section.
* * * * *

0
6. In Sec.  520.538, remove paragraph (c) and redesignate paragraph (d)
as new paragraph (c); and revise paragraph (b) to read as follows:

Sec.  520.538  Deracoxib.

* * * * *
    (b) Sponsors. See Nos. 013744, 058198, and 086101 in Sec.
510.600(c) of this chapter.
* * * * *

0
7. In Sec.  520.905a, revise paragraphs (e)(2), (3), and (4) to read as
follows:

Sec.  520.905a  Fenbendazole suspension.

* * * * *
    (e) * * *
    (2) Beef and dairy cattle--(i) Amount. Administer orally 2.3 mg/lb
of body weight (5 mg/kg).
    (ii) Indications for use. For the treatment and control of:
Lungworms: Adult (Dictyocaulus viviparus); Stomach worms: Adult brown
stomach worms (Ostertagia ostertagi); adult and fourth-stage larvae
barberpole worms (Haemonchus contortus and H. placei); adult and
fourth-stage larvae small stomach worms (Trichostrongylus axei);
Intestinal worms (adult and fourth-stage larvae): Hookworms (Bunostomum
phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus),
small intestinal worms (Cooperia punctata and C. oncophora), bankrupt
worms (Trichostrongylus colubriformis), and nodular worms
(Oesophagostomum radiatum).
    (iii) Limitations. Milk taken from cows during treatment and for 48
hours

after the last treatment must not be used for human consumption. Cattle
must not be slaughtered for human consumption within 8 days following
last treatment with this drug product. Not for 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.
    (3) Beef cattle--(i) Amount. Administer orally 4.6 mg/lb of body
weight (10 mg/kg).
    (ii) Indications for use. For the treatment and control of stomach
worms (fourth-stage inhibited larvae/type II ostertagiasis), Ostertagia
ostertagi, and tapeworms, Moniezia benedeni.
    (iii) Limitations. Cattle must not be slaughtered for human
consumption within 8 days following last treatment with this drug
product. Not for 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. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
    (4) Goats--(i) Amount. Administer orally 2.3 mg/lb of body weight
(5 mg/kg).
    (ii) Indications for use. For the treatment and control of stomach
worms (adults) Haemonchus contortus and Teladorsagia circumcincta.
    (iii) Limitations. Goats must not be slaughtered for human
consumption within 6 days following last treatment with this drug
product. Because a milk discard time has not been established, do not
use in lactating goats.
* * * * *

Sec.  520.905e  [Removed]

0
8. Remove Sec.  520.905e.

0
9. In Sec.  520.1286, revise paragraph (c)(2)(ii) to read as follows:

Sec.  520.1286  Lotilaner.

* * * * *
    (c) * * *
    (2) * * *
    (ii) Indications for use. Kills adult fleas, and for the treatment
and prevention of flea infestations (Ctenocephalides felis) for 1 month
in cats and kittens 8 weeks of age and older, and weighing 2.0 pounds
or greater; and for the treatment and control of Ixodes scapularis
(black-legged tick) for 1 month in cats and kittens 6 months of age and
older, and weighing 2.0 pounds or greater.
* * * * *

0
10. In Sec.  520.2086, in paragraph (c)(2), add a sentence at the end
of the paragraph to read as follows:

Sec.  520.2086  Sarolaner.

* * * * *
    (c) * * *
    (2) * * * For the prevention of Borrelia burgdorferi infections as
a direct result of killing Ixodes scapularis vector ticks.
* * * * *

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

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

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

0
12. In Sec.  522.812, revise paragraphs (b)(1) and (e)(1)(i) to read as
follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (1) Nos. 016729, 017033, 055529, and 058198 for use of product
described in paragraph (a)(1) of this section as in paragraph (e)(1) of
this section; and
* * * * *
    (e) * * *
    (1) * * *
    (i) Amount. 2.5 mg per kilogram (/kg) of body weight (1.13 mg per
pound) as a single, intramuscular, initial dose followed by use of
tablets twice daily for 2 to 3 days beyond cessation of clinical signs
to a maximum of 30 days.
* * * * *

0
13. Revise Sec.  522.1225 to read as follows:

Sec.  522.1225  Ketoprofen.

    (a) Specifications. Each milliliter of solution contains 100
milligrams (mg) ketoprofen.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter.
    (1) No. 054771 for use as in paragraphs (d)(1) and (d)(2) of this
section.
    (2) No. 061133 for use as in paragraph (d)(1) of this section.
    (c) Related tolerances. See Sec.  556.345 of this chapter.
    (d) Conditions of use--(1) Horses--(i) Amount. Administer by
intravenous injection 1.0 mg per pound (/lb) of body weight once daily
for up to 5 days.
    (ii) Indications for use. For alleviation of inflammation and pain
associated with musculoskeletal disorders in horses.
    (iii) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
    (2) Cattle--(i) Amount. Administer by subcutaneous injection 3 mg
per kilogram (1.36 mg/lb) of body weight once daily for up to 3 days.
    (ii) Indications for use. For the control of pyrexia associated
with bovine respiratory disease (BRD) in beef heifers, beef steers,
beef calves 2 months of age and older, beef bulls, replacement dairy
heifers, and dairy bulls.
    (iii) Limitations. Not for use in reproducing animals over 1 year
of age. Cattle must not be slaughtered for human consumption within 48
hours following last treatment with this drug product. Not for use in
female dairy cattle 1 year of age or older, including dry dairy cows;
use in these cattle may cause drug residues in milk and/or in calves
born to these cows or heifers. Not for 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. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.

Sec.  Sec.  522.1697, 522.1698, and 522.1704  [Redesignated]

0
14. Redesignate Sec. Sec.  522.1697, 522.1698, and 522.1704 as
Sec. Sec.  522.1700, 522.1702, and 522.1703.

0
15. Add Sec.  522.2632 to read as follows:

Sec.  522.2632  Tulathromycin and ketoprofen.

    (a) Specifications. Each milliliter of solution contains 100
milligrams (mg) tulathromycin and 120 milligrams (mg) ketoprofen.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.345 and 556.745 of this
chapter.
    (d) Conditions of use--(1) Cattle--(i) Amount. Administer as a
single subcutaneous injection 2.5 mg tulathromycin and 3 mg ketoprofen
per kilogram (1.1 mL/100 lb) of body weight.
    (ii) Indications for use. For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, Histophilus somni, and Mycoplasma bovis, and control of
pyrexia associated with BRD in beef steers, beef heifers, beef calves 2
months of age and older, beef bulls, dairy bulls, and replacement dairy
heifers.
    (iii) Limitations. Not for use in reproducing animals over 1 year
of age. Cattle must not be slaughtered for human consumption within 18
days following last treatment with this drug product. Not for use in
female dairy cattle 1 year of age or older, including dry dairy cows;
use in these cattle may cause drug residues in milk and/or in calves
born to these cows or heifers. Not for 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. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
    (2) [Reserved]

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

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

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

0
17. In Sec.  524.1146, revise paragraphs (b)(1) and (2) to read as
follows:

Sec.  524.1146  Imidacloprid and moxidectin.

* * * * *
    (b) * * *
    (1) Nos. 017030, 058198, and 061651 for use of product described in
paragraph (a)(1) of this section as in paragraph (d)(1) of this
section.
    (2) Nos. 017030, 058198, and 061651 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(2) of this
section.
* * * * *

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

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

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

0
19. In Sec.  556.275, revise paragraph (c) to read as follows:

Sec.  556.275  Fenbendazole.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  520.905a, 520.905b,
520.905c, 520.905d, and 558.258 of this chapter.

0
20. Add Sec.  556.345 to read as follows:

Sec.  556.345  Ketoprofen.

    (a) Acceptable daily intake (ADI). The ADI for total residue of
ketoprofen is 5 [micro]g/kg of body weight per day.
    (b) Tolerances. The tolerances for ketoprofen (marker residue) are:
    (1) Cattle. (i) Kidney (target tissue): 0.36 ppm.
    (ii) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  522.1225 and 522.2632
of this chapter.

0
21. In Sec.  556.745, revise paragraph (c) to read as follows:

Sec.  556.745  Tulathromycin.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  522.2630 and 522.2632
of this chapter.

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

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

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

0
23. In Sec.  558.128, revise paragraph (e)(4) introductory text to read
as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (4) Cattle. It is used as follows:
* * * * *

0
24. In Sec.  558.258, revise paragraph (e)(3)(iii) to read as follows:

Sec.  558.258  Fenbendazole.

* * * * *
    (e) * * *
    (3) * * *
    (iii) Free-choice medicated feeds--(A) Proprietary formulas (Sec.
510.455(e)(2) of this chapter). The following feeds can be manufactured
only per an approved proprietary formula and specifications:

----------------------------------------------------------------------------------------------------------------
         Amount fenbendazole                Indications for use                Limitations             Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 750 mg/lb of protein block (to     Beef cattle: For the           Feed free choice at a rate of       000061
 provide 5 mg/kg body weight (2.27 mg/  treatment and control of:      0.1 pound of block per 100
 lb)).                                  Lungworms: adult               pounds of body weight per
                                        (Dictyocaulus viviparus);      day for 3 days to deliver a
                                        Stomach worms: Adult brown     total of 2.27 mg
                                        stomach worms (Ostertagia      fenbendazole per pound of
                                        ostertagi), adult and fourth-  body weight. Cattle must not
                                        stage larvae barberpole        be slaughtered for human
                                        worms (Haemonchus              consumption within 16 days
                                        contortus), fourth-stage       following last treatment
                                        larvae barberpole worms (H.    with this drug product. Not
                                        placei), and adult and         for use in female dairy
                                        fourth-stage larvae small      cattle 20 months of age or
                                        stomach worms                  older, including dry dairy
                                        (Trichostrongylus axei);       cows. Use in these cattle
                                        Intestinal worms (adult and    may cause drug residues in
                                        fourth-stage larvae):          milk and/or in calves born
                                        Hookworms (Bunostomum          to these cows or heifers.
                                        phlebotomum), thread-necked    Not for use in beef calves
                                        intestinal worms               less than 2 months of age,
                                        (Nematodirus helvetianus),     dairy calves, and veal
                                        small intestinal worms         calves. A withdrawal period
                                        (Cooperia punctata and C.      has not been established for
                                        oncophora), bankrupt worms     this product in pre-
                                        (Trichostrongylus              ruminating calves.
                                        colubriformis), and nodular
                                        worms (Oesophagostomum
                                        radiatum).
(2) 750 mg/lb of molasses block (to    Beef cattle: For the           Feed free choice at a rate of       000061
 provide 5 mg/kg body weight (2.27 mg/  treatment and control of:      0.1 pound of block per 100
 lb)).                                  Lungworms: adult               pounds of body weight per
                                        (Dictyocaulus viviparus);      day for 3 days to deliver a
                                        Stomach worms: Adult brown     total of 2.27 mg
                                        stomach worms (Ostertagia      fenbendazole per pound of
                                        ostertagi), adult and fourth-  body weight. Cattle must not
                                        stage larvae barberpole        be slaughtered for human
                                        worms (Haemonchus              consumption within 11 days
                                        contortus), fourth-stage       following last treatment
                                        larvae barberpole worms (H.    with this drug product. Not
                                        placei), and adult and         for use in female dairy
                                        fourth-stage larvae small      cattle 20 months of age or
                                        stomach worms                  older, including dry dairy
                                        (Trichostrongylus axei);       cows. Use in these cattle
                                        Intestinal worms (adult and    may cause drug residues in
                                        fourth-stage larvae):          milk and/or in calves born
                                        Hookworms (Bunostomum          to these cows or heifers.
                                        phlebotomum), thread-necked    Not for use in beef calves
                                        intestinal worms               less than 2 months of age,
                                        (Nematodirus helvetianus),     dairy calves, and veal
                                        small intestinal worms         calves. A withdrawal period
                                        (Cooperia punctata and C.      has not been established for
                                        oncophora), bankrupt worms     this product in pre-
                                        (Trichostrongylus              ruminating calves.
                                        colubriformis), and nodular
                                        worms (Oesophagostomum
                                        radiatum).
----------------------------------------------------------------------------------------------------------------

    (B) Published formulas (Sec.  510.455(e)(1) of this chapter). The
following feeds can be manufactured only per one of the formulas and
specifications published below:
    (1) Amount. 5 mg/kg body weight (2.27 mg/lb), including the
following formulations:

------------------------------------------------------------------------
                                                           International
             Ingredient \1\                   Percent        feed No.
------------------------------------------------------------------------
(i) Free-choice, dry Type C feed:

    Salt (sodium chloride)..............           59.00        6-04-152
    Monosodium phosphate................           31.16        6-04-288
    Dried cane molasses.................            3.12        4-04-695
    Zinc sulfate........................            0.76        6-05-556
    Copper sulfate......................            0.45        6-01-720
    Fenbendazole 20% Type A article.....            5.51             n/a
(ii) Free-choice, dry Type C feed:
    Salt (sodium chloride)..............           35.93        6-04-152
    Dicalcium phosphate (18.5% P).......           32.44        6-00-080
    Calcium carbonate (38% Ca)..........           15.93        6-01-069
    Magnesium oxide (56% Mg)............           10.14        6-02-756
    Zinc sulfate........................            1.47        6-05-556
    Mineral oil.........................            1.00        8-03-123
    Dried cane molasses (46% sugars)....            0.98        4-04-695
    Potassium iodide....................            0.01        6-03-759
    Fenbendazole 20% Type A article.....            2.10             n/a
(iii) Free-choice, liquid Type C feed:
    Cane molasses \2\...................          80.902        4-13-251
    Water...............................            9.36             n/a
    Urea solution, 55%..................            7.05        5-05-707
    Phosphoric acid 75% (feed grade)....            2.00        6-03-707
    Xantham gum.........................            0.20        8-15-818
    Trace minerals......................            0.20             n/a
    Vitamin premix......................            0.01             n/a
    Fenbendazole 20% Type A article.....           0.278             n/a
------------------------------------------------------------------------
\1\ The content of any added vitamin and trace mineral may be varied;
  however, they should be comparable to those used by the manufacturer
  for other free-choice cattle feeds. Formulation modifications require
  FDA approval prior to marketing. Selenium is not approved for the free-
  choice formulations described in paragraph (e)(3)(iii) of this
  section. Free-choice cattle feeds containing selenium must comply with
  published regulations (see 21 CFR 573.920).
\2\ The percentage of cane molasses and water in the formulation may be
  adjusted as needed in order to bring the brix value of the molasses to
  the industry standard of 79.5 brix.

    (2) Indications for use. As in paragraph (e)(3)(i) of this section.
    (3) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27
mg/lb) of body weight to cattle over a 3- to 6-day period. Retreatment
may be needed after 4 to 6 weeks. Cattle must not be slaughtered within
13 days following last treatment. For dairy cattle the milk discard
time is zero hours. A withdrawal period has not been established for
this product in pre-ruminating calves. Do not use in calves to be
processed for veal.
* * * * *

0
25. In Sec.  558.355, add a heading to paragraph (f)(3) to read as
follows:

Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (3) Cattle--
* * * * *

    Dated: October 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24075 Filed 11-5-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Pages 12508-12509]
[FR Doc No: 2014-04813]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0157]

Guidance for Industry: Biologics License Applications for
Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord
Blood Intended for Hematopoietic and Immunologic Reconstitution in
Patients With Disorders Affecting the Hematopoietic System;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry: Biologics
License Applications for Minimally Manipulated, Unrelated Allogeneic
Placental/Umbilical Cord Blood Intended for Hematopoietic and
Immunologic Reconstitution in Patients With Disorders Affecting the
Hematopoietic System'' dated March 2014. The guidance document provides
recommendations for manufacturers, generally cord blood banks, to apply
for licensure of minimally manipulated, unrelated allogeneic placental/
umbilical cord blood, for hematopoietic and immunologic reconstitution
in patients with disorders affecting the hematopoietic system that are
inherited, acquired, or result from myeloablative treatment. The
guidance document is intended to assist manufacturers in obtaining a
biologics license. The guidance contains information about the
manufacture of minimally manipulated, unrelated allogeneic placental/
umbilical cord blood and how to comply with

applicable regulatory requirements. The guidance announced in this
document finalizes the draft guidance of the same title dated June 2013
and supersedes the guidance entitled ``Guidance for Industry: Minimally
Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood
Intended for Hematopoietic Reconstitution for Specified Indications''
dated October 2009.

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

ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Guidance for Industry: Biologics License Applications for Minimally
Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
Intended for Hematopoietic and Immunologic Reconstitution in Patients
With Disorders Affecting the Hematopoietic System'' dated March 2014.
The guidance document provides recommendations for manufacturers to
apply for licensure of minimally manipulated, unrelated allogeneic
placental/umbilical cord blood, for hematopoietic and immunologic
reconstitution in patients with disorders affecting the hematopoietic
system that are inherited, acquired, or result from myeloablative
treatment. The guidance document is intended to assist manufacturers
obtain a biologics license. The guidance contains information about the
manufacture of minimally manipulated, unrelated, allogeneic placental/
umbilical cord blood and how to comply with applicable regulatory
requirements.
    In the Federal Register of June 17, 2013 (78 FR 36196), FDA
announced the availability of the draft guidance of the same title
dated June 2013. FDA received a few comments on the draft guidance and
those comments were considered as the guidance was finalized. Minor
changes were made to improve clarity. The guidance announced in this
notice finalizes the draft guidance of the same title dated June 2013
and supersedes the guidance entitled ``Guidance for Industry: Minimally
Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood
Intended for Hematopoietic Reconstitution for Specified Indications''
dated October 2009.
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
    Elsewhere in this issue of the Federal Register, we also are
announcing the availability of another, related guidance entitled
``Guidance for Industry and FDA Staff: Investigational New Drug
Applications for Minimally Manipulated, Unrelated Allogeneic Placental/
Umbilical Cord Blood Intended for Hematopoietic and Immunologic
Reconstitution in Patients with Disorders Affecting the Hematopoietic
System.'' That guidance supersedes the document entitled ``Guidance for
Industry and FDA Staff: Investigational New Drug Applications (INDs)
for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical
Cord Blood Intended for Hematopoietic Reconstitution for Specified
Indications'' dated June 2011.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 201 have been approved under
OMB control number 0910-0572; 21 CFR part 211 have been approved under
OMB control number 0910-0139; 21 CFR part 600 have been approved under
OMB control number 0910-0308; 21 CFR parts 601 and 610, and Form FDA
356h have been approved under OMB control number 0910-0338; and 21 CFR
part 1271 have been approved under OMB control number 0910-0543.

III. Comments

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

IV. Electronic Access

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

    Dated: February 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04813 Filed 3-4-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4193-4194]
[FR Doc No: 2018-01700]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Number: PR18-25-000.
    Applicants: Corning Natural Gas Corporation.
    Description: Tariff filing per 284.123(b),(e)/: 2018 Rate Changes
to be effective 1/22/2018.
    Filed Date: 1/19/18.
    Accession Number:<PHONE_NUMBER>49.
    Comments/Protests Due: 5 p.m. ET 2/9/18.

    Docket Numbers: RP18-264-001.
    Applicants: Destin Pipeline Company, L.L.C.
    Description: Tariff Amendment: Amended Fuel Retention Adjustment to
be effective 1/1/2018.
    Filed Date: 1/16/18.
    Accession Number: 20180116-5225.
    Comments Due: 5 p.m. ET 1/29/18.

    Docket Numbers: RP18-348-000.
    Applicants: East Tennessee Natural Gas, LLC.

    Description: Sec.  4(d) Rate Filing: Duke K410135 Release for 2018-
01-13 to be effective 1/13/2018.
    Filed Date: 1/16/18.
    Accession Number: 20180116-5072.
    Comments Due: 5 p.m. ET 1/29/18.

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

    Dated: January 24, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-01700 Filed 1-29-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 187 (Thursday, September 30, 2021)]
[Notices]
[Pages 54213-54215]
[FR Doc No: 2021-21328]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0981]

Fee Rate for Using a Tropical Disease Priority Review Voucher in
Fiscal Year 2022

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rates for using a tropical disease priority review
voucher for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the Food and Drug Administration
Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect
priority review user fees for certain applications for review of drug
and biological products when those applications use a tropical disease
priority review voucher. These vouchers are awarded to the sponsors of
certain tropical disease product applications submitted after September
27, 2007, the enactment date of FDAAA, upon FDA approval of such
applications. The amount of the fee submitted to FDA with applications
using a tropical disease priority review voucher is determined each
fiscal year based on the difference between the average cost incurred
by FDA to review a human drug application designated as priority review
in the previous fiscal year and the average cost incurred in the review
of an application that is not subject to priority review in the
previous fiscal year. This notice establishes the tropical disease
priority review fee rate for FY 2022 and outlines the payment
procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Andrew Bank, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
62019A, Beltsville, MD, 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1102 of FDAAA (Pub. L. 110-85) added section 524 to the
FD&C Act (21 U.S.C. 360n). In section 524, Congress encouraged
development of new drug and biological products for prevention and
treatment of tropical diseases by offering additional incentives for
obtaining FDA approval of such products. Under section 524, the sponsor
of an eligible human drug application submitted after September 27,
2007, for a tropical disease (as defined in section 524(a)(3) of the
FD&C Act) shall receive a priority review voucher upon approval of the
tropical disease product application (as defined in section 524(a)(4)
of the FD&C Act), assuming other criteria are met. The recipient of a
tropical disease priority review voucher may either use the voucher for
a future human drug application submitted to FDA under section
505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351(a) of
the Public Health Service Act (PHS Act) (42 U.S.C. 262), or transfer
(including by sale) the voucher to another party. The voucher may be
transferred repeatedly until it ultimately is used for a human drug
application submitted to FDA under section 505(b)(1) of the FD&C Act or
section 351(a) of the PHS Act. A priority review is a review conducted
with a Prescription Drug User Fee Act (PDUFA) goal date of 6 months
after the receipt or filing date, depending upon the type of
application. Information regarding the PDUFA goals is available at:
https://www.fda.gov/media/99140/download.
    The sponsor that uses a priority review voucher is entitled to a
priority review but must pay FDA a priority review user fee in addition
to any other fee required by PDUFA. FDA published guidance on its
website about how this tropical disease priority review voucher program
operates (available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tropical-disease-priority-review-vouchers).
    This notice establishes the tropical disease priority review fee
rate for FY 2022 as $1,266,651 and outlines FDA's process for
implementing the collection of the priority review user fees. This rate
is effective on October 1, 2021, and will remain in effect through
September 30,

2022, for applications submitted with a tropical disease priority
review voucher.

II. Tropical Disease Priority Review User Fee Rate for FY 2022

    FDA interprets section 524(c)(2) of the FD&C Act as requiring that
FDA determine the amount of the tropical disease priority review user
fee each fiscal year based on the difference between the average cost
incurred by FDA in the review of a human drug application subject to
priority review in the previous fiscal year and the average cost
incurred by FDA in the review of a human drug application that is not
subject to priority review in the previous fiscal year.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. As described in the PDUFA goals letter, FDA has committed
to reviewing and acting on 90 percent of the applications granted
priority review status within this expedited timeframe. Normally, an
application for a human drug or biological product will qualify for
priority review if the product is intended to treat a serious condition
and, if approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation receives a standard review. As described in the PDUFA goals
letter, FDA has committed to reviewing and acting on 90 percent of
standard applications within 10 months of the receipt or filing date,
depending on the type of application. A priority review involves a more
intensive level of effort and a higher level of resources than a
standard review.
    FDA is setting a fee for FY 2022, which is to be based on standard
cost data from the previous fiscal year, FY 2021. However, the FY 2021
submission cohort has not been closed out yet, thus the cost data for
FY 2021 are not complete. The latest year for which FDA has complete
cost data is FY 2020. Furthermore, because FDA has never tracked the
cost of reviewing applications that get priority review as a separate
cost subset, FDA estimated this cost based on other data that the
Agency has tracked. The Agency expects all applications that received
priority review would contain clinical data. The application categories
with clinical data for which FDA tracks the cost of review are: (1) New
drug applications (NDAs) for a new molecular entity (NME) with clinical
data and (2) biologics license applications (BLAs).
    The total cost for FDA to review NME NDAs with clinical data and
BLAs in FY 2020 was $227,248,467. There was a total of 86 applications
in these two categories (53 NME NDAs with clinical data and 33 BLAs).
(Note: these numbers exclude the President's Emergency Plan for AIDS
Relief NDAs; no investigational new drug review costs are included in
this amount.) Of these applications 55 (35 NDAs and 20 BLAs) received
priority review and the remaining 31 (18 NDAs and 13 BLAs) received
standard reviews. Because a priority review compresses a review that
ordinarily takes 10 months into 6 months, FDA estimates that a
multiplier of 1.67 (10 months divided by 6 months) should be applied to
non-priority review costs in estimating the effort and cost of a
priority review as compared to a standard review. This multiplier is
consistent with published research on this subject, which supports a
priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). Using
FY 2020 figures, the costs of a priority and standard review are
estimated using the following formula:

(55 [alpha] x 1.67) + (31 [alpha]) = $227,248,467

where ``[alpha]'' is the cost of a standard review and ``[alpha] times
1.67'' is the cost of a priority review. Using this formula, the cost
of a standard review for NME NDAs and BLAs is calculated to be
$1,849,804 (rounded to the nearest dollar) and the cost of a priority
review for NME NDAs and BLAs is 1.67 times that amount, or $3,089,173
(rounded to the nearest dollar). The difference between these two cost
estimates, or $1,239,369, represents the incremental cost of conducting
a priority review rather than a standard review.
    For the FY 2022 fee, FDA will need to adjust the FY 2020
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2021, to adjust the FY 2020 amount
for cost increases in FY 2021. That adjustment, published in the
Federal Register on August 16, 2021 (see 86 FR 45732), setting FY 2022
PDUFA fees, is 2.2013 percent for the most recent year, not compounded.
Increasing the FY 2020 incremental priority review cost of $1,239,369
by 2.2013 percent (or 0.022013) results in an estimated cost of
$1,266,651 (rounded to the nearest dollar). This is the tropical
disease priority review user fee amount for FY 2022 that must be
submitted with a priority review voucher for a human drug application
in FY 2022, in addition to any PDUFA fee that is required for such an
application.

III. Fee Rate Schedule for FY 2022

    The fee rate for FY 2022 is set out in table 1:

     Table 1--Tropical Disease Priority Review Schedule for FY 2022
------------------------------------------------------------------------
                                                         Priority review
                      Fee category                         fee rate for
                                                             FY 2022
------------------------------------------------------------------------
Application submitted with a tropical disease priority       $1,266,651
 review voucher in addition to the normal PDUFA fee....
------------------------------------------------------------------------

IV. Implementation of Tropical Disease Priority Review User Fee

    Under section 524(c)(4)(A) of the FD&C Act, the priority review
user fee is due upon submission of a human drug application for which
the priority review voucher is used. Section 524(c)(4)(B) of the FD&C
Act specifies that the application will be considered incomplete if the
priority review user fee and all other applicable user fees are not
paid in accordance with FDA payment procedures. In addition, FDA may
not grant a waiver, exemption, reduction, or refund of any fees due and
payable under section 524 of the FD&C Act (see section 524(c)(4)(C)),
and FDA may not collect priority review voucher fees ``except to the
extent provided in advance in appropriation Acts.'' (Section
524(c)(5)(B) of the FD&C Act.)
    The tropical disease priority review fee established in the new fee
schedule must be paid for any application that is received on or after
October 1, 2021, and is submitted with a priority review voucher. This
fee must be paid in addition to any other fee due under PDUFA. Payment
should be made in U.S. currency by electronic check, check, bank draft,
wire transfer, credit card, or U.S. postal money order payable to the
order of the Food and Drug Administration. The preferred payment method
is online using electronic check (Automated Clearing

House (ACH) also known as eCheck). Secure electronic payments can be
submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. (Note: only full payments are accepted. No
partial payments can be made online). Once you search for your invoice,
select ``Pay Now'' to be redirected to Pay.gov. Note that electronic
payment options are based on the balance due. Payment by credit card is
available for balances that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments should
be made using U.S. bank accounts as well as U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after the
user fee identification (ID) number is generated.
    If paying by paper check, the user fee ID number should be included
on the check, followed by the words ``Tropical Disease Priority
Review.'' All paper checks should be in U.S. currency from a U.S. bank
made payable and mailed to: Food and Drug Administration, P.O. Box
979107, St. Louis, MO 63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only.) If you have any
questions concerning courier delivery, contact the U.S. Bank at 314-
418-4013. (This telephone number is only for questions about courier
delivery.) The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
    If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. The originating financial
institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required to add that
amount to the payment to ensure that the invoice is paid in full. The
account information is as follows: U.S. Dept. of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY 10045, Account Number: 75060099,
Routing Number: 021030004, SWIFT: FRNYUS33.

V. Reference

    The following reference is on display with the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD, 20852,<PHONE_NUMBER>, and is available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
it is not available electronically at https://www.regulations.gov as
this reference is copyright protected. FDA has verified the website
address, as of the date this document publishes in the Federal
Register, but websites are subject to change over time.

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006, available at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.25.2.313.

    Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21328 Filed 9-29-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 21, 2010 (Volume 75, Number 98)]
[Notices]
[Page 28602]
[DOCID:fr21my10-69]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-2-001]

PELICO Pipeline, LLC; Notice of Compliance Filing

May 13, 2010.
    Take notice that on April 26, 2010, PELICO Pipeline, LLC (PELICO),
filed its Statement of Operating Conditions (SOC) in compliance with
the March 23, 2010 Letter Order and pursuant to section 284.123(e) of
the Commission's regulations. PELICO states that it made revisions to
the SOC including a stand-alone statement of rates and incorporating
the Settlement terms as required by the March 23rd Order.
    Any person desiring to participate in this proceeding must file a
motion to intervene or a protest in accordance with Rules 211 and 214
of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and
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 date as indicated below. Anyone filing an intervention or
protest must serve a copy of that document on the Applicant. Anyone
filing an intervention or protest on or before the intervention or
protest date need not 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 Thursday, May 27, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-12233 Filed 5-20-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Page 73618]
[FR Doc No: 2014-29024]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket No. FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1359]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency; DHS.

ACTION: Notice; correction.

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SUMMARY: On January 30, 2014, FEMA published in the Federal Register a
proposed flood hazard determination notice at 79 FR 4950 that contained
a table which included a Web page address through which the Preliminary
Flood Insurance Rate Map (FIRM), and where applicable, the Flood
Insurance Study (FIS) report for the communities listed in the table
could be accessed. The information available through the Web page
address has subsequently been updated. The table provided here
represents the proposed flood hazard determinations and communities
affected for King and Queen County, Virginia, and Incorporated Areas.

DATES: Comments are to be submitted on or before March 11, 2015.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the table below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1359, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER> or (email)
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed in the table below, in
accordance with Section 110 of the Flood Disaster Protection Act of
1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own, or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are also used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP may only be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://www.floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The communities affected by the flood hazard determinations are
provided in the table below. Any request for reconsideration of the
revised flood hazard determinations shown on the Preliminary FIRM and
FIS report that satisfies the data requirements outlined in 44 CFR
67.6(b) is considered an appeal. Comments unrelated to the flood hazard
determinations will also be considered before the FIRM and FIS report
are made final.

Correction

    In the proposed flood hazard determination notice published at 79
FR 4950 in the January 30, 2014, issue of the Federal Register, FEMA
published a table titled ``King and Queen County, Virginia, and
Incorporated Areas.'' This table contained a Web page address through
which the Preliminary FIRM, and where applicable, FIS report for the
communities listed in the table could be accessed online. A Revised
Preliminary FIRM and/or FIS report have subsequently been issued for
some or all of the communities listed in the table. The information
available through the Web page address listed in the table has been
updated to reflect the Revised Preliminary information and is to be
used in lieu of the information previously available.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: November 24, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
         King and Queen County, Virginia, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Unincorporated Areas of King and Queen   King and Queen County Complex
 County.                                  Building, County
                                          Administrator's Office, 242
                                          Allens Circle, Suite L, King
                                          and Queen Court House, VA
                                          23085.
------------------------------------------------------------------------

[FR Doc. 2014-29024 Filed 12-10-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 86, Number 89 (Tuesday, May 11, 2021)]
[Notices]
[Pages 25891-25892]
[FR Doc No: 2021-09950]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2006-0042]

CSA Group Testing & Certification Inc.: Grant of Expansion of
Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for CSA Group Testing & Certification Inc. for
expansion of recognition as a Nationally Recognized Testing Laboratory
(NRTL).

DATES: The expansion of the scope of recognition becomes effective on
May 11, 2021.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor by phone<PHONE_NUMBER> or
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor by phone
(202) 693-2110 or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of CSA Group Testing & Certification Inc. (CSA) as a NRTL.
CSA's expansion covers the addition of four test standards to the NRTL
scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
properly approved by the NRTL to meet OSHA standards that require
testing and certification of the products.
    The agency processes an application by a NRTL for initial
recognition and for an expansion or renewal of this recognition,
following requirements in Appendix A, 29 CFR 1910.7. This appendix
requires that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides the preliminary finding. In the second notice,
the agency provides the final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational web page for each NRTL,
including CSA, which details the NRTL's scope of recognition. These
pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    CSA submitted an application, dated July 17, 2019 (OSHA-2006-0042-
0018), to expand their recognition to include four additional test
standards. OSHA staff performed a detailed analysis of the application
packet and reviewed other pertinent information. OSHA did not perform
any on-site reviews in relation to this application.
    OSHA published the preliminary notice announcing CSA's expansion
application in the Federal Register on February 23, 2021 (86 FR 11004).
The agency requested comments by March 10, 2021, but it received no
comments in response to this notice. OSHA is now proceeding with this
final notice to grant expansion of CSA's scope of recognition.
    To obtain or review copies of all public documents pertaining to
the CSA's application, go to http://www.regulations.gov or contact the
Docket Office, Occupational Safety and Health Administration, Docket
No. OSHA-2006-0042 contains all materials in the record concerning
CSA's recognition. Please note: Due to the COVID-19 pandemic, the
Docket Office is closed to the public at this time but can be contacted
at<PHONE_NUMBER>.

II. Final Decision and Order

    OSHA staff examined CSA's expansion application, its capability to
meet the requirements of the test standards, and other pertinent
information. Based on its review of this evidence, OSHA finds that CSA
meets the requirements of 29 CFR 1910.7 for expansion of its
recognition, subject to the limitations and conditions listed in this
notice. OSHA, therefore, is proceeding with this final notice to grant
CSA's scope of recognition. OSHA limits the expansion of CSA's
recognition to testing and certification of products for demonstration
of conformance to the test standards listed below in Table 1.

 Table 1--List of Appropriate Test Standards for Inclusion in CSA's NRTL
                          Scope of Recognition
------------------------------------------------------------------------
             Test standard                     Test standard title
------------------------------------------------------------------------
UL 2271................................  Standard for Batteries for Use
                                          in Light Electric Vehicle
                                          (LEV) Applications.
UL 9540................................  Standard for Energy Storage
                                          Systems and Equipment.
UL 2054................................  Standard for Household and
                                          Commercial Batteries.
UL 1973................................  Standard for Batteries for Use
                                          in Stationary, Vehicle
                                          Auxiliary Power and Light
                                          Electric Rail (LER)
                                          Applications.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before using them in the
workplace. Consequently, if a test standard also covers any products
for which OSHA does not require such testing and certification, a
NRTL's scope of recognition does not include these products.
    The American National Standards Institute (ANSI) may approve the
test standards listed above as American National Standards. However,
for convenience, we may use the designation of the standards-developing
organization for the standard as opposed to the ANSI designation. Under
the NRTL Program's policy (see OSHA Instruction CPL 1-0.3, Appendix C,
paragraph XIV), any NRTL recognized for a particular test standard may
use either the proprietary version of the test standard or the ANSI
version of that standard. Contact ANSI to determine whether a test
standard is currently ANSI-approved.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
CSA must abide by the following conditions of the recognition:
    1. CSA must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. CSA must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. CSA must continue to meet the requirements for recognition,
including all previously published conditions on CSA's scope of
recognition, in all areas for which it has recognition.

    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of CSA as a NRTL, subject to the limitations and
conditions specified above.

III. Authority and Signature

    James S. Frederick, Principal Deputy Assistant Secretary of Labor
for Occupational Safety and Health, 200 Constitution Avenue NW,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the agency is issuing this notice pursuant to Section 29
U.S.C. 655(6)(d), Secretary of Labor's Order No. 8-2020 (85 FR 58393;
Sept. 18, 2020), and 29 CFR 1905.11.

    Signed at Washington, DC, on April 8, 2021.
James S. Frederick,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2021-09950 Filed 5-10-21; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: October 1, 2007 (Volume 72, Number 189)]
[Notices]
[Page 55850-55852]
[DOCID:fr01oc07-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56504; File No. SR-NASD-2007-055]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc. (n/k/a Financial Industry Regulatory Authority, Inc.);
Order Approving Proposed Rule Change Relating to Interpretative
Material 9216, Violations Appropriate for Disposition Under Plan
Pursuant to SEC Rule 19d-1(c)(2)

 September 24, 2007.

I. Introduction

    On July 24, 2007, the National Association of Securities Dealers,
Inc. (``NASD'') (n/k/a Financial Industry Regulatory Authority, Inc.
(``FINRA'')) \1\ filed with the Securities and Exchange Commission
(``Commission'' or ``SEC'') pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Exchange Act'') \2\ and Rule 19b-4
thereunder,\3\ a proposed rule change to amend Interpretative Material
9216 (Violations Appropriate for Disposition Under Plan Pursuant to SEC
Rule 19d-1(c)(2)) (``IM-9216'') to expand the list of violations
eligible for disposition under NASD's Minor Rule Violation Plan
(``MRVP''). The proposed rule change was published for comment in the
Federal Register on August 7, 2007.\4\ The Commission received no
comment letters on the proposed rule change. This order approves the
proposed rule change.
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    \1\ On July 26, 2007, the Commission approved a proposed rule
change filed by NASD to amend NASD's Certificate of Incorporation to
reflect its name change to the Financial Industry Regulatory
Authority, Inc., or FINRA, in connection with the consolidation of
the member firm regulatory functions of NASD and NYSE Regulation,
Inc. See Securities Exchange Act Release No. 56146 (July 26, 2007).
    \2\ 15 U.S.C. 78s(b)(1).
    \3\ 17 CFR 240.19b-4.
    \4\ See Securities Exchange Act Release No. 56175 (July 31,
2007), 72 FR 44201 (``Notice'').
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II. Description of the Proposed Rule Change

    In connection with the recently approved plan to consolidate the
member regulation operations of NASD and the NYSE Group, Inc. into a
single organization (``Transaction''),\5\ NASD proposed to amend IM-
9216 to expand the list of violations eligible for

disposition under NASD's MRVP to include certain NYSE rules that
pertain to the regulation of member firm conduct. \6\ The proposed rule
change would amend NASD's MRVP to include those Incorporated NYSE Rules
currently enumerated in NYSE's MRVP. This would permit FINRA, during
the interim period until the adoption of a consolidated rulebook, to
impose a fine for minor rule violations by a Dual Member of the
Incorporated NYSE Rules in lieu of commencing disciplinary proceedings.
As discussed in Release No. 34-56147, NASD is not proposing to
incorporate, among other rules, the NYSE disciplinary rules or related
interpretations, including NYSE's MRVP as set forth in NYSE Rule 476A
(Imposition of Fines for Minor Violation(s) of Rules). \7\
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    \5\ On July 26, 2007, the Commission approved amendments to
NASD's By-Laws to implement governance and related changes to
accommodate the consolidation of the member firm regulatory
functions of NASD and NYSE Regulation, Inc. See Securities Exchange
Act Release No. 56145 (July 26, 2007). The date of closing of the
Transaction was July 30, 2007.
    \6\ Until the adoption of a consolidated rulebook that would
reduce to one the two sets of rules currently applicable to members
of both the NASD and NYSE (``Dual Members''), NASD has proposed to
incorporate into FINRA's rulebook certain NYSE Rules that pertain to
the regulation of member firm conduct (``Incorporated NYSE Rules'').
See Securities Exchange Act Release No. 56147 (July 26, 2007) (SR-
NASD-2007-054, Exhibit 5) (incorporating certain NYSE Rules relating
to member firm conduct into FINRA's rulebook) (``Release No. 34-
56147''). As noted in Release No. 34-56147, the Incorporated NYSE
Rules apply solely to FINRA members that are Dual Members on or
after the date of closing of the Transaction. NASD represented that
FINRA will work expeditiously to consolidate the rules that apply to
its member firms. See Notice, supra note 4. The Incorporated NYSE
Rules will apply solely to Dual Members until such time as FINRA
adopts, subject to Commission approval, consolidated rules
applicable to all of its members.
    \7\ NASD is not proposing to incorporate NYSE's MRVP (NYSE Rule
476A), because NYSE Rule 476A contains procedures that would
conflict with the finding of a minor rule violation by FINRA. For
example, NYSE Rule 476A permits a person against whom a fine is
imposed to contest the NYSE's fine determination by, among other
things, appealing to the NYSE board of directors.
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    The proposed amendments to IM-9216 also would specify the
applicability of the rules listed therein to various members of FINRA.
Specifically, any Dual Member (including any persons affiliated with
such member) may be subject to a fine under Rule 9216(b) with respect
to any rule listed in IM-9216 that applies to such member or person;
provided, however, that any Dual Member that was not also a member of
NASD as of the date of closing of the Transaction and that does not
engage in any activities that would have required it to be an NASD
member (and its affiliated persons that are not otherwise subject to
NASD rules) would only be subject to a fine under Rule 9216(b) with
respect to the following rules listed in IM-9216: any NYSE rule,
Exchange Act rule, NASD By-Law or Schedule to By-Laws, or the NASD Rule
8000 Series. In addition, any member of FINRA that is not also a member
of the NYSE (and its associated persons that are not otherwise subject
to NYSE rules) may be subject to a fine under Rule 9216(b) with respect
to any rule listed in IM-9216, with the exception of the NYSE rules.
    NASD is not proposing to adopt the provision in NYSE's MRVP that
establishes a $5,000 maximum fine that may be imposed under NYSE's MRVP
for minor violations of NYSE rules. Rather, FINRA would continue to
apply the $2,500 maximum fine level under NASD's MRVP in determining
fine levels for minor violations of either an NASD or NYSE rule
included in NASD's MRVP. \8\
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    \8\ Rule 19d-1(c)(2) under the Exchange Act, 17 CFR 240.19d-
1(c)(2), provides that any disciplinary action taken by a self-
regulatory organization (``SRO'') against any person of a rule of
the SRO that has been designated as a minor rule violation pursuant
to a plan is not considered ``final'' for purposes of Rule 19d-
1(c)(1) under the Exchange Act, 17 CFR 240.19d-1(c)(2), if the
sanction imposed consists of a fine not exceeding $2,500 and the
sanctioned person has not sought an adjudication, including a
hearing, or otherwise exhausted his administrative remedies at the
SRO with respect to the matter. SROs are permitted to report such
minor rule violations (where the fine does not exceed $2,500) to the
Commission on a periodic, rather than immediate, basis. In addition,
members are not required to report ``minor rule violations'' on the
Forms BD, U4 or U5 (as such term is defined on the forms). These
forms provide that a rule violation may be designated as ``minor''
under a plan approved by the Commission if, among other things, the
sanction imposed consists of a fine of $2,500 or less. See also
Securities Exchange Act Release No. 40193 (July 10, 1998), 63 FR
39338 (July 22, 1998) (Order Granting Approval to Proposed Rule
Change Relating to Fines for Disruptive Action on the Options Floor)
(SR-PCX-98-21) (stating in the context of amendments to the MRVP of
the Pacific Exchange, Inc's (``PCX'') (now NYSE Arca, Inc.) that, as
noted in PCX's MRVP, pursuant to Securities Exchange Act Release No.
30958, any person or organization found in violation of a minor rule
under an MRVP is not required to report such violation on Form BD,
provided that, among other things, the sanction imposed consists of
a fine not exceeding $2,500).
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    The proposed rule change also would delete from IM-9216 references
to NASD rules that have been rescinded.

III. Discussion

    After careful review, the Commission finds that the proposed rule
change is consistent with the Exchange Act and the rules and
regulations thereunder applicable to a national securities
association.\9\ Specifically, the Commission finds that the proposed
rule change is consistent with Section 15A(b)(2) of the Exchange Act
\10\ in that it will permit FINRA to be so organized to carry out the
purposes of the Exchange Act and to enforce compliance by FINRA members
and persons associated with its members with the Exchange Act, the
rules and regulations thereunder, and FINRA rules. The Commission also
finds that the proposed rule change is consistent with Section
15A(b)(6) of the Exchange Act \11\ in that it is designed, among other
things, to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest. Further, the Commission finds that the proposed rule change
is consistent with Section 15A(b)(7) of the Exchange Act \12\ in that
it will provide that FINRA members and persons associated with its
members will be appropriately disciplined for violations of the
Exchange Act, the rules and regulations thereunder, and FINRA rules.
The Commission also finds the proposed rule change consistent with
Section 15A(b)(8) of the Exchange Act \13\ in that it furthers the
statutory goals of providing a fair procedure for the disciplining of
members and persons associated with members.
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    \9\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \10\ 15 U.S.C. 78o-3(b)(2).
    \11\ 15 U.S.C. 78o-3(b)(6).
    \12\ 15 U.S.C. 78o-3(b)(7).
    \13\ 15 U.S.C. 78o-3(b)(8).
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    As a result of the proposed rule change, FINRA would be able to
impose a fine for minor rule violations with respect to the
Incorporated NYSE Rules that currently are enumerated in NYSE's MRVP.
The proposed rule change is designed to ensure that Dual Members will
have substantially the same set of regulatory obligations immediately
following the closing date of the Transaction that such members had
prior to the closing of the Transaction until the member conduct rules
of the NASD and NYSE are consolidated into a single set of FINRA rules.
The proposed rule change provides a reasonable means of addressing
violations of both NASD and NYSE rules that do not rise to the level of
requiring formal disciplining proceedings, while providing greater
flexibility in handling certain violations. The Commission expects that
FINRA will continue to conduct surveillance with due diligence and make
a determination based on its findings, on a case-by-case basis, whether
a fine under the MRVP is appropriate, or whether a violation requires
formal disciplinary action.

    The proposed rule change also provides that Dual Members will be
subject to FINRA's disciplinary procedures, including FINRA's current
$2,500 maximum fine level for minor rule violations of either an NASD
or NYSE rule included in FINRA's MRVP. While there are some
distinctions between NASD's and NYSE's rules, both sets of rules
applicable to the disciplinary process were previously approved by the
Commission as consistent with the Exchange Act, generally following
notice and comment.\14\ Accordingly, although Dual Members and their
associated persons no longer would be subject to NYSE's disciplinary
procedures with respect to the Incorporated NYSE Rules, but to FINRA's
instead, the Commission finds that the proposed rule change should help
ensure greater consistency in the administration of the disciplinary
process for FINRA and its members, as well as in the related reporting
obligations for minor violations of rules.
---------------------------------------------------------------------------

    \14\ See Securities Exchange Act Release Nos. 21688 (January 25,
1985), 50 FR 5025 (February 5, 1985) (order approving NYSE's Rule
476A--Imposition of Fines for Minor Violation(s) of Rules); and
32383 (May 28, 1993), 58 FR 31768 (June 4, 1993) (order approving
establishment of NASD's Minor Rule Violations Plan).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Exchange Act,\15\ that the proposed rule change (SR-NASD-2007-055), be,
and it hereby is, approved.
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    \15\ 15 U.S.C. 78s(b)(2).

For the Commission, by the Division of Market Regulation, pursuant
to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E7-19271 Filed 9-28-07; 8:45 am]

BILLING CODE 8011-01-P