[Federal Register Volume 60, Number 123 (Tuesday, June 27, 1995)]
[Rules and Regulations]
[Pages 33109-33110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15594]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 522
Animal Drugs, Feeds, and Related Products; Xylazine Injection
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 approval of an abbreviated new animal drug
application (ANADA) filed by Chanelle Pharmaceuticals Manufacturing
Ltd. The ANADA provides for intravenous and intramuscular use of
xylazine injection in horses and intramuscular use in Cervidae spp. to
produce sedation accompanied by a shorter period of analgesia.
EFFECTIVE DATE: June 27, 1995.
FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center For Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1617.
SUPPLEMENTARY INFORMATION: Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, County Galway, Ireland, filed ANADA 200-139 which provides
for intravenous and intramuscular use of Chanazine (100
milligrams/milliliter (mg/mL)) Injectable (xylazine hydrochloride
equivalent to 100 mg xylazine per mL) in horses and intramuscular use
in Cervidae spp. (fallow deer, mule deer, Sika deer, white-tailed deer,
and elk) to produce sedation accompanied by a shorter period of
analgesia. The drug is limited to use by or on the order of a licensed
veterinarian.
-Approval of ANADA 200-139 for Chanelle's Chanazine
(xylazine 100 mg/mL) Injectable is as a generic copy of Miles' NADA
047-956 for Rompun (xylazine 100 mg/mL) Injectable. The ANADA
is approved as of May 16, 1995, and the regulations are amended by
revising 21 CFR 522.2662(b) to reflect the approval. The basis of
approval is discussed in the freedom of information summary.
-In addition, Chanelle Pharmaceuticals Manufacturing Ltd. has not
previously been listed in the animal drug regulations as the sponsor of
an approved application. At this time, 21 CFR 510.600(c) is amended to
add entries for the firm. [[Page 33110]]
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a
summary of safety and effectiveness data and information submitted to
support approval of this application may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects
21 CFR Part 510
-Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 522
-Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and
522 are amended as follows:
-PART 510--NEW ANIMAL DRUGS-
1. The authority citation for 21 CFR part 510 continues to read as
follows:
-Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e).
- 2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding a new entry for ``Chanelle Pharmaceuticals
Manufacturing Ltd.,'' and in the table in paragraph (c)(2) by
numerically adding a new entry for ``061651'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of -
approved applications.
* * * * *
(c) * * *
(1) * * *
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Firm name and address Drug labeler code
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* * * * *
Chanelle Pharmaceuticals 061651
Manufacturing Ltd., Loughrea,
County Galway, Ireland.
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
061651............................. Chanelle Pharmaceuticals
Manufacturing Ltd., Loughrea,
County Galway, Ireland
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS-
3. The authority citation for 21 CFR part 522 continues to read as
follows:
-Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
-4. Section 522.2662 is amended by revising the first sentence in
paragraph (b) to read as follows:
Sec. 522.2662 Xylazine hydrochloride injection.
* * * * *
(b) Sponsor. See 000856 and 061651 in Sec. 510.600(c) of this
chapter for use as horses, wild deer, and elk. * * *
-* * * * *
Dated: June 15, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-15594 Filed 6-26-95; 8:45 am]
BILLING CODE 4160-01-F
