[Federal Register Volume 75, Number 166 (Friday, August 27, 2010)]
[Rules and Regulations]
[Pages 52621-52622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21296]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 522
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Change of Sponsor; Withdrawal of Approval of
New Animal Drug Applications; Deslorelin Acetate; Dichlorophene and
Toluene Capsules; Pyrantel Pamoate Suspension
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for a new animal drug
application (NADA) from Peptech Animal Health Pty, Ltd. to Dechra, Ltd.
and for an abbreviated new animal drug application (ANADA) from Church
& Dwight Co., Inc., to Pegasus Laboratories, Inc. In addition, FDA is
removing those portions of the regulations that reflect approval of two
other NADAs transferred from Church & Dwight Co., Inc., to Pegasus
Laboratories, Inc., for which voluntary withdrawal of approval was
requested after the change of sponsorship. In a notice published
elsewhere in this issue of the Federal Register, FDA is withdrawing
approval of these two NADAs.
DATES: This rule is effective:
1. August 27, 2010 for 21 CFR 510.600(c), 520.2043, and 522.533.
2. September 7, 2010 for 21 CFR 520.580.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Church & Dwight Co., Inc., 469 North
Harrison St., Princeton, NJ 08543-5297, has informed FDA that it has
transferred ownership of, and all rights and interest in, NADA 101-497
and NADA 101-498 for oral capsules containing dichlorophene and
toluene, and ANADA 200-028 for an oral suspension of pyrantel pamoate
to Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.
Accordingly, the agency is amending the regulations in 21 CFR 520.2043
to reflect the transfer of ownership.
Peptech Animal Health Pty, Ltd., 19-25 Khartoum Rd., Macquarie
Park, New South Wales 2113, Australia, has informed FDA that it has
transferred ownership of, and all rights and interest in, NADA 141-044
for subcutaneous implants containing deslorelin acetate to Dechra,
Ltd., Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-
Trent, Staffordshire, ST7 1XW, United Kingdom. Accordingly, the agency
is amending the regulations in 21 CFR 522.533 to reflect the transfer
of ownership and a current format.
Following these changes of sponsorship, Pegasus Laboratories, Inc.,
has requested that FDA withdraw approval of the two NADAs for
dichlorophene and toluene capsules because they are no longer
manufactured or marketed. In a notice published elsewhere in this issue
of the Federal Register, FDA gave notice that approval of NADA 101-497
and 101-498, and all supplements and amendments thereto, is withdrawn,
effective September 7, 2010. As provided in the regulatory text of this
document, the agency is amending the regulations in 21 CFR 520.580 to
reflect these withdrawals of approval.
Also, following these changes of sponsorship, Church & Dwight Co.,
Inc., and Peptech Animal Health Pty, Ltd., are no longer sponsors of an
approved application. Accordingly, 21 CFR 510.600(c) is being amended
to remove the entries for these firms.
This rule 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
[[Page 52622]]
congressional review requirements in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 and 522
Animal drugs.
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Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, and 522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
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1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
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2. In Sec. 510.600, in the table in paragraph (c)(1), remove the
entries for ``Church & Dwight Co., Inc.'' and ``Peptech Animal Health
Pty, Ltd.''; and in the table in paragraph (c)(2), remove the entries
for ``010237'' and ``064288''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
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3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.580 [Amended].
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4. In paragraph (b)(1) of Sec. 520.580, remove ``010237,''.
Sec. 520.2043 [Amended]
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5. In paragraph (b)(2) of Sec. 520.2043, remove ``010237'' and in its
place add ``055246''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
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6. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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7. In Sec. 522.533, revise the section heading and paragraph (b), add
paragraph (c), and remove paragraph (d) to read as follows:
Sec. 522.533 Deslorelin.
* * * * *
(b) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses and ponies--(1) Amount. One implant
per mare subcutaneously in the neck.
(2) Indications for use. For inducing ovulation within 48 hours in
estrous mares with an ovarian follicle greater than 30 millimeters in
diameter.
(3) Limitations. Do not use in horses or ponies intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Dated: August 23, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-21296 Filed 8-26-10; 8:45 am]
BILLING CODE 4160-01-S