2011-7214. New Animal Drugs; Arsanilate Sodium; Sulfaethoxypyridazine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correcting amendments.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to remove sections pertaining to use of arsanilate sodium and sulfaethoxypyridazine in medicated feed because there are no currently approved new animal drug applications (NADAs) for such uses. Conforming amendments are also being made. This action is being taken to improve the accuracy of the regulations.

DATES:

This rule is effective March 28, 2011.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

FDA has determined the animal drug regulations describe conditions of use for arsanilate sodium and sulfaethoxypyridazine in medicated feed for which no NADA is currently approved.

1. Arsanilate sodium § 558.60 (21 CFR 558.60). In the Federal Register of December 18, 1986 (51 FR 45346), FDA proposed to remove § 558.20 Drugs used in medicated feeds in use before January 1, 1958, which are not otherwise listed; interim listing (21 CFR 558.20) because this section in part 558 subpart A—General Provisions did not provide an appropriate basis upon which to approve medicated feed applications and because several of the drugs listed were not the subject of approved NADAs. Among other exceptions, FDA proposed to transfer the arsanilate sodium provisions of § 558.20 to § 558.60 in subpart B—Specific New Animal Drugs for Use in Animal Feeds (subpart B) to reflect their status as approved conditions of use.

In 1991, FDA issued a final rule removing most of § 558.20 (56 FR 19263, April 26, 1991) and codifying approved uses in subpart B. Elsewhere in the same issue of the Federal Register, FDA reproposed the removal of the remaining portions of § 558.20 that pertained to certain uses of arsanilate sodium (56 FR 19332, April 26, 1991). FDA reproposed those portions of the rule because it recognized that some of the uses it had proposed to codify in subpart B did not appear to be the subject of approved NADAs, as previously stated. In the discussion of the reproposed changes, FDA tentatively concluded that NADA 8-966 for arsanilate sodium for use in swine feed was voluntarily withdrawn by a letter dated November 12, 1973. The Agency acknowledged this withdrawal by a letter dated January 16, 1974 (see 56 FR 19332 at 19333, Refs. 1 and 2).

In 1992, FDA issued a final rule removing the remaining portions of § 558.20 (57 FR 1641, January 15, 1992) and noted that no evidence or comments were received on the 1991 reproposed rule, which had requested that anyone claiming to hold an approved NADA for arsanilate sodium in swine feed submit evidence to substantiate the approval. FDA concluded that NADA 8-966 providing for use of arsanilate sodium in medicated feeds for swine was voluntarily withdrawn at the request of the sponsor (see 56 FR 19332 and Refs. 1 and 2 of the reproposal).

After careful review of its NADA records, FDA has concluded that all uses of arsanilate sodium in medicated feeds in NADA 8-966 were voluntarily withdrawn by the sponsor in 1973 and that there is no currently approved NADA providing for the use of arsanilate sodium in medicated feed or in any dosage form. Accordingly, the animal drug regulations in part 558 (21 CFR part 558) are amended by removing § 558.60. Conforming amendments are also being made in §§ 558.55 and 558.680 by removing reference to use in combination with amprolium and zoalene, respectively. This action is being taken to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to improve the accuracy of the regulations.

2. Sulfaethoxypyridazine ( §§ 558.579). In 1966, FDA approved a food additive petition and codified the safe use of sulfaethoxypyridazine in feed and drinking water of swine at § 121.280 (21 CFR 121.280) (31 FR 2425 at 2426, February 5, 1966). In 1968, § 121.280 was amended to add use in cattle in feed and water, and by tablet and injection, and to make all uses, including use in feed restriction to “for sale by or on the order of a licensed veterinarian” (33 FR 627 at 628, January 18, 1968). A 1969 amendment revised that use restriction to read “for use by or on the order of a licensed veterinarian” (34 FR 20272, December 25, 1969).

In a 1976 reorganization of certain food additive regulations from 21 CFR part 121 to new part 558 New Animal Drugs For Use in Animal Feed, § 121.280 was redesignated as § 558.579 (41 FR 10983 at 11005, March 15, 1976). In the intervening 35 years there have been no required annual drug experience reports, or any product stability reports, submitted for any NADA for use of sulfaethoxypyridazine in medicated feed. At this time and after careful review of its NADA records, FDA has concluded that that there is no approved NADA for the use of sulfaethoxypyridazine in medicated feed for swine or cattle. Accordingly, the animal drug regulations in part 558 are amended by removing § 558.579. A conforming amendment is also being made in 21 CFR 522.2240 to remove a provision for administration of sulfaethoxypyridazine injectable solution followed by use of sulfaethoxypyridazine medicated cattle feed. This action is being taken to comply with the FD&C Act and to improve the accuracy of the regulations.

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 congressional review requirements in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 522

• Animal drugs

21 CFR Part 558

• Animal drugs
• Animal feeds

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 522 and 558 are amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 522 continues to read as follows:

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

2. In § 522.2240 revise paragraph (e)(3) to read as follows:

§ 522.2240

Sulfaethoxypyridazine.

* * * * *

(e) * * *

(3) Limitations. Administer intravenously for not more than 4 days; or first treatment may be followed by 3 days of treatment with sulfaethoxypyridazine in drinking water or tablets in accordance with §§ 520.2240a(e) and 520.2240b(e) of this chapter; as sodium sulfaethoxypyridazine; do not treat within 16 days of slaughter; as sole source of sulfonamide; milk that has been taken from animals during treatment and for 72 hours (6 milkings) after the latest treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

3. The authority citation for 21 CFR part 558 continues to read as follows:

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

§ 558.4

[Amended]

4. In § 558.4, in paragraph (d), in the “Category II” table, remove the entries for “Arsanilate sodium” and “Sulfaethoxypyridazine”.

§ 558.55

[Amended]

5. In § 558.55, in the tables in paragraphs (d)(2)(i), (d)(2)(ii), and (d)(2)(iv), remove the entries for “Arsanilate sodium 90 (0.01%)”.

§ 558.60

[Removed]

6. Remove § 558.60.

§ 558.579

[Removed]

7. Remove § 558.579.

§ 558.680

[Amended]

8. In § 558.680, in the tables in paragraphs (d)(1)(i), (d)(1)(ii), and (d)(1)(iii), remove the entries for “Arsanilate sodium 90 (0.01%)”.

Dated: March 23, 2011.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.