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intramammary dosage forms (21 CFR § 526.1696a Penicillin G procaine. DEPARTMENT OF THE TREASURY
526.1696a) are also amended to correct (a) Specifications. Each 10-milliliter
several errors and to reflect a current single-dose syringe contains penicillin Internal Revenue Service
format. G procaine equivalent to 100,000 units
This rule does not meet the definition of penicillin G. 26 CFR Part 301
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because (b) Related tolerances. See § 556.510 [TD 8697]
it is a rule of ‘‘particular applicability.’’ of this chapter.
Therefore, it is not subject to the RIN 1545–AT91
(c) Sponsors. See Nos. 010515 and
congressional review requirements in 5
050604 in § 510.600(c) of this chapter. Simplification of Entity Classification
U.S.C. 801–808.
(d) Conditions of use in lactating Rules; Correction
List of Subjects cows—(1) Amount. Infuse one 10-
milliliter dose into each infected AGENCY: Internal Revenue Service (IRS),
21 CFR Part 510 Treasury.
quarter. Treatment may be repeated at
Administrative practice and 12-hour intervals for not more than ACTION: Correcting amendment.
procedure, Animal drugs, Labeling, three doses, as indicated by clinical SUMMARY: This document contains a
Reporting and recordkeeping response.
requirements. correction to final regulations (TD
(2) Indications for use. For the 8697), that were published in the
21 CFR Parts 520 and 526 treatment of mastitis caused by Federal Register on Wednesday,
Streptococcus agalactiae, S. December 18, 1996 (61 FR 66584). The
Animal drugs. dysgalactiae, and S. uberus in lactating final regulations classify certain
21 CFR Part 558 cows. business organizations under an elective
Animal drugs, Animal feeds. (3) Limitations. Milk that has been regime.
taken from animals during treatment DATES: This correction is effective on
■ Therefore, under the Federal Food, and for 60 hours after the latest
Drug, and Cosmetic Act and under April 4, 2008 and is applicable on
treatment must not be used for food. January 1, 1997.
authority delegated to the Commissioner Animals must not be slaughtered for
of Food and Drugs and redelegated to FOR FURTHER INFORMATION CONTACT:
food during treatment or within 3 days
the Center for Veterinary Medicine, 21 Stephen J. Hawes, (202) 622–3860 (not
after the latest treatment.
CFR parts 510, 520, 526, and 558 are a toll-free number).
(e) Conditions of use in dry cows—(1)
amended as follows: SUPPLEMENTARY INFORMATION:
Amount. Infuse one 10-milliliter dose
PART 510—NEW ANIMAL DRUGS into each infected quarter at time of Background
drying-off.
The final regulations (TD 8697) that is
■ 1. The authority citation for 21 CFR (2) Indications of use. For the the subject of this correction is under
part 510 continues to read as follows: treatment of mastitis caused by section 7701 of the Internal Revenue
Authority: 21 U.S.C. 321, 331, 351, 352, Streptococcus agalactiae in dry cows. Code.
353, 360b, 371, 379e. (3) Limitations. Discard all milk for 72
hours (6 milkings) following calving, or Need for Correction
§ 510.600 [Amended] later as indicated by the marketable As published, TD 8697 contains an
■ 2. In § 510.600, in the table in quality of the milk. Animals must not be error that may prove to be misleading
paragraph (c)(1), remove the entry for slaughtered for food within 14 days and is in need of clarification.
‘‘Eon Labs Manufacturing, Inc.’’; and in postinfusion.
the table in paragraph (c)(2) remove the List of Subjects 26 CFR Part 301
entry for ‘‘000185’’. PART 558—NEW ANIMAL DRUGS FOR Employment taxes, Estate taxes,
USE IN ANIMAL FEEDS Excise taxes, Gift taxes, Income taxes,
PART 520—ORAL DOSAGE FORM Penalties, Reporting and recordkeeping
NEW ANIMAL DRUGS ■ 8. The authority citation for 21 CFR requirements.
part 558 continues to read as follows:
■ 3. The authority citation for 21 CFR Correction of Publication
Authority: 21 U.S.C. 360b, 371.
part 520 continues to read as follows: ■ Accordingly, 26 CFR part 301 is
Authority: 21 U.S.C. 360b. § 558.274 [Amended]
corrected by making the following
■ 9. In § 558.274, amend paragraph correcting amendment:
§ 520.390b [Amended]
(a)(2) by removing ‘‘Nos. 043733 and’’
■ 4. In § 520.390b, in paragraph (b)(1), and adding in its place ‘‘No.’’. PART 301—PROCEDURE AND
remove ‘‘, 000185,’’. ADMINISTATION
§ 558.625 [Amended]
§ 520.2345a [Amended] ■ Paragraph 1. The authority citation
■ 10. In § 558.625, remove and reserve for part 301 continues to read in part as
■ 5. In § 520.2345a, remove paragraph paragraph (b)(3). follows:
(b)(3).
§ 558.630 [Amended] Authority: 26 U.S.C. 7805 * * *
PART 526—INTRAMAMMARY DOSAGE
FORMS ■ 11. In § 558.630, amend paragraph ■ Par. 2. Section 301.7701–2(b)(8)(i) is
(b)(10) by removing ‘‘043733,’’. amended by revising the entry for
■ 6. The authority citation for 21 CFR Dated: March 26, 2008. ‘‘Romania, Societe pe Actiuni’’ to read
ebenthall on PRODPC61 with RULES
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Federal Register / Vol. 73, No. 66 / Friday, April 4, 2008 / Rules and Regulations 18443
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