[Federal Register Volume 91, Number 106 (Wednesday, June 3, 2026)]
[Rules and Regulations]
[Pages 33071-33072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-11104]
[[Page 33071]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 558
[Docket No. FDA-2025-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Change of
Sponsor; Change of Sponsor Address; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment; correcting amendment.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
final rule that published in the Federal Register of April 16, 2026.
That final rule updated regulations to reflect application-related
actions for new animal drug applications and abbreviated new animal
drug applications during October, November, and December of 2025. The
final rule published with some inadvertent errors in the instructions
for technical amendments. This document corrects those errors.
DATES: This rule is effective June 3, 2026.
FOR FURTHER INFORMATION CONTACT: James Delaney, Center for Veterinary
Medicine, Food and Drug Administration, 5001 Campus Drive, College
Park, MD 20740, 240-402-5677, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of April 16, 2026
(91 FR 20337), FDA published the final rule ``New Animal Drugs;
Approval of New Animal Drug Applications; Withdrawal of Approval of New
Animal Drug Applications; Change of Sponsor; Change of Sponsor
Address'' with errors. On page 20340, amendatory language in
instruction 9 for Sec. 520.1263b Lincomycin hydrochloride soluble
powder, did not properly provide instructions to revise paragraphs
(d)(1), (d)(2) heading, (d)(2)(i), (d)(2)(iii), and (d)(3). On page
20343, amendatory language in instruction 30 for Sec. 558.305
Laidlomycin propionate potassium, did not properly provide instructions
to revise paragraphs (d)(1) introductory text, (d)(2), (d)(3)
introductory text, and (e) introductory text including table headings.
On page 20346, amendatory language in instruction 33 for Sec. 558.500
Ractopamine, did not include instructions to revise paragraph (d)(2)
introductory text. This document corrects these errors.
List of Subjects
21 CFR Part 520
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Accordingly, 21 CFR parts 520 and 558 are corrected by making the
following correcting amendments:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.1263b, revise paragraphs (d)(1), (d)(2) heading,
(d)(2)(i) and (iii), and (d)(3)(i) and (ii) to read as follows:
Sec. 520.1263b Lincomycin hydrochloride soluble powder.
* * * * *
(d) * * *
(1) Swine--(i) Amount. Administer at a dose rate of 250 milligrams
(mg) of lincomycin per gallon of drinking water. In clinical studies,
this dose rate provided an average of 3.8 mg of lincomycin per pound of
body weight per day. The drug should be administered for a minimum of 5
consecutive days beyond the disappearance of symptoms (bloody stools)
up to a maximum of 10 consecutive days. If water treatment is
discontinued prior to this time, a lincomycin treatment program may be
continued with lincomycin Type A medicated article at 100 grams
lincomycin per ton of complete feed as the sole ration according to
label directions. A dose of 3.8 mg lincomycin per pound of body weight
may be maintained by medicating the drinking water at a concentration
of 250 mg per gallon of drinking water when pigs are consuming 1.5
gallons per 100 lb of body weight per day. Under these circumstances
the concentration of lincomycin required in medicated water may be
adjusted to compensate for variations in age and weight of animals, the
nature and severity of disease symptoms, environmental temperature and
humidity, each of which affects water consumption. For use in automatic
water proportioner to deliver 1 ounce of stock solution per gallon of
drinking water. After a treatment program is discontinued, a control
program for swine dysentery may be followed by feeding lincomycin Type
A medicated article at 40 grams lincomycin per ton of complete feed as
the sole ration.
(ii) Indications for use. For the treatment of swine dysentery
(bloody scours) in swine. Not for use in pregnant swine or swine
intended for breeding.
(iii) Limitations. Discard medicated drinking water if not used
within 2 days. Fresh stock should be prepared daily. Do not use the
water treatment and the feed treatment simultaneously. Do not allow
rabbits, hamsters, guinea pigs, horses, or ruminants access to water
containing lincomycin. Ingestion by these species may result in severe
gastrointestinal effects. If clinical signs of bloody scours (watery,
mucoid, or bloody stools) have not improved during the first 6 days of
medication, discontinue treatment and redetermine the diagnosis. On
rare occasions, some pigs may show reddening of the skin, swelling of
the anus, and irritable behavior. These conditions have been self-
correcting within five to seven days without discontinuing the
lincomycin treatment. The safety of lincomycin has not been
demonstrated for pregnant swine or swine intended for breeding. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) Broiler chickens--(i) Amount. Administer at a dose rate of 64
mg of lincomycin per gallon of drinking water. Start medication as soon
as the diagnosis of necrotic enteritis is determined. The drug should
be administered for 7 consecutive days. After water medication is
discontinued, a control program for necrotic enteritis may be followed
by feeding lincomycin Type A medicated article at 2 grams lincomycin
per ton of complete feed.
* * * * *
(iii) Limitations. Not for use in laying hens or breeder chickens.
Discard medicated drinking water if not used within 2 days. Fresh stock
should be prepared daily. Do not use the water treatment and the feed
treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs,
horses, or ruminants access to water containing lincomycin. Ingestion
by these species may result in severe gastrointestinal effects. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
(3) * * *
(i) Amount. Administer 100 mg lincomycin per hive once weekly for 3
weeks. Mix 250 mg LINCOMIX Soluble Powder (100 mg lincomycin) with 20 g
confectioners'/powder sugar and dust over the top bars of the brood
chamber.
[[Page 33072]]
(ii) Indications for use. For the control of American foulbrood
(Paenibacillus larvae) in honey bees.
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
4. In Sec. 558.305, revise paragraphs (d)(1) introductory text,
(d)(2), (d)(3) introductory text, (e) introductory text, and the column
headings for the table in paragraph (e) to read as follows:
Sec. 558.305 Laidlomycin propionate potassium.
* * * * *
(d) * * *
(1) Laidlomycin propionate potassium Type B liquid medicated feeds
may be manufactured from dry laidlomycin propionate potassium Type A
medicated articles. The Type B liquid medicated feeds must have a pH of
6.0 to 8.0, dry matter of 62 to 75 percent, and bear appropriate mixing
directions as follows:
* * * * *
(2) The expiration date of the Type B liquid medicated feed is 21
days after date of manufacture. The expiration date for the dry Type C
medicated feed made from the Type B liquid medicated feed is 7 days
after date of manufacture.
(3) Labeling for all Type B medicated feeds (liquid and dry) and
Type C medicated feeds containing laidlomycin propionate potassium
shall bear the following statements:
* * * * *
(e) Conditions of use. It is used in growing beef steers and
heifers fed in confinement for slaughter as follows:
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Laidlomycin propionate potassium Combination in Indications for
in grams per ton grams/ton use Limitations Sponsor
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* * * * * * *
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* * * * *
0
5. In Sec. 558.500, revise paragraph (d)(2) introductory text to read
as follows:
Sec. 558.500 Ractopamine.
* * * * *
(d) * * *
(2) Labeling of Type A medicated articles and Type B and Type C
medicated feeds intended for swine shall bear the following:
* * * * *
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11104 Filed 6-2-26; 8:45 am]
BILLING CODE 4164-01-P