[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Rules and Regulations]
[Pages 17026-17027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7214]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 558
[Docket No. FDA-2011-N-0003]
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:
[email protected].
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 Sec. 558.60 (21 CFR 558.60). In the Federal
Register of December 18, 1986 (51 FR 45346), FDA proposed to remove
Sec. 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 Sec. 558.20 to Sec.
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 Sec. 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 Sec. 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
Sec. 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 Sec.
558.60. Conforming amendments are also being made in Sec. Sec. 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 (Sec. Sec. 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 Sec.
121.280 (21 CFR 121.280) (31 FR 2425 at 2426, February 5, 1966). In
1968, Sec. 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, Sec. 121.280 was redesignated as Sec. 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 Sec. 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.''
[[Page 17027]]
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
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.2240 revise paragraph (e)(3) to read as follows:
Sec. 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
Sec. Sec. 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
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.4 [Amended]
0
4. In Sec. 558.4, in paragraph (d), in the ``Category II'' table,
remove the entries for ``Arsanilate sodium'' and
``Sulfaethoxypyridazine''.
Sec. 558.55 [Amended]
0
5. In Sec. 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%)''.
Sec. 558.60 [Removed]
0
6. Remove Sec. 558.60.
Sec. 558.579 [Removed]
0
7. Remove Sec. 558.579.
Sec. 558.680 [Amended]
0
8. In Sec. 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.
[FR Doc. 2011-7214 Filed 3-25-11; 8:45 am]
BILLING CODE 4160-01-P