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Federal Register / Vol. 73, No.

66 / Friday, April 4, 2008 / Rules and Regulations 18441

direct final rule that published in the Drug Administration, 7500 Standish Final rule; technical
ACTION:
Federal Register of December 4, 2007 Pl., Rockville, MD 20855, 240–276– amendment.
(72 FR 68064), to amend certain 8268, or
regulations as the first phase of an Brian Hasselbalch, Center for Drug SUMMARY: The Food and Drug
incremental approach to modernize or Evaluation and Research (HFD– Administration (FDA) is amending the
clarify some of the current good 320), Food and Drug animal drug regulations by removing
manufacturing practice (CGMP) Administration, 10903 New those portions that reflect approval of
regulations for finished Hampshire Ave., Silver Spring, MD
seven new animal drug applications
pharmaceuticals, as well as harmonize 20993, 301–796–3279.
(NADAs) because FDA is withdrawing
some of the CGMP requirements with Authority: Therefore, under the approval of the NADAs.
those of other foreign regulators and Federal Food, Drug, and Cosmetic Act,
other FDA regulations. The comment and under authority delegated to the DATES: This rule is effective April 4,
period closed February 19, 2008. FDA is Commissioner of Food and Drugs, the 2008.
withdrawing the direct final rule direct final rule published on December
because the agency received significant 4, 2007 (72 FR 68064) is withdrawn. FOR FURTHER INFORMATION CONTACT:
adverse comments. FDA will consider Pamela K. Esposito, Center for
Dated: March 24, 2008.
the comments received under our usual Veterinary Medicine (HFV–212), Food
Jeffrey Shuren,
procedures for notice and comment in and Drug Administration, 7519 Standish
Associate Commissioner for Policy and
connection with the notice of proposed Planning.
Pl., Rockville, MD 20855, 240–276–
rulemaking that was published in the 9067; e-mail:
[FR Doc. E8–7107 Filed 4–3–08; 8:45 am]
Federal Register of December 4, 2007, pamela.esposito@fda.hhs.gov.
BILLING CODE 4160–01–S
as a companion to the direct final rule
(72 FR 68113). SUPPLEMENTARY INFORMATION: The
following sponsors have requested that
DATES: The direct final rule published at DEPARTMENT OF HEALTH AND
72 FR 68064 on December 4, 2007, is FDA withdraw approval of the seven
HUMAN SERVICES
withdrawn as of April 4, 2008. NADAs listed below because the
Food and Drug Administration products are no longer manufactured or
FOR FURTHER INFORMATION CONTACT:
marketed:
Mary Malarkey, Center for Biologics
Evaluation and Research (HFM– 21 CFR Parts 510, 520, 526, and 558
600), Food and Drug
Animal Drugs, Feeds, and Related
Administration, 1401 Rockville
Products; Withdrawal of Approval of
Pike, Rockville, MD 20852–1448,
NADAs; Technical Amendment
301–827–6190, or
Dennis Bensley, Center for Veterinary AGENCY: Food and Drug Administration,
Medicine (HFV–140), Food and HHS.

21 CFR Cite Affected


Sponsor NADA Number Product (Drug) (Sponsor Drug Labeler Code)

Eon Labs Manufacturing, Inc., NADA 65–063, 520.2345a (000185)


227–15 North Conduit Ave., Tetracycline capsules
Laurelton, NY 11413
NADA 65–345, 520.390b (000185)
Chloramphenicol capsules

G.C. Hanford Manufacturing Co., NADA 65–465, 526.1696a (010515)


P.O. Box 1017, AQUA-MAST
Syracuse, NY 13201 (penicillin G procaine)

International Nutrition, Inc., NADA 95–551, 558.625 (043733)


7706 ‘‘I’’ Plaza, TYLAN 5 Premix
Omaha, NE 68127 (tylosin phosphate)

NADA 109–688, 558.274 (043733)


HYGROMIX 2.4 Premix
(hygromycin B)

NADA 109–816, 558.630 (043733)


TYLAN 10 SULFA-G Premix
(tylosin phosphate and sulfamethazine)

Pfizer, Inc., NADA 103–758, Not codified


235 East 42d St., TERAMIX–10 Premix
New York, NY 10017 (oxytetracycline)
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Following the withdrawal of approval Therefore, 21 CFR 510.600(c) is As provided below, the animal drug
of these NADAs, Eon Labs amended to remove entries for this regulations are amended to reflect the
Manufacturing, Inc., is no longer sponsor. withdrawal of approvals. The
sponsor of an approved application. regulations for penicillin G procaine

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18442 Federal Register / Vol. 73, No. 66 / Friday, April 4, 2008 / Rules and Regulations

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

part 526 continues to read as follows: Bernadette Dunham,


as follows:
Authority: 21 U.S.C. 360b. Director, Center for Veterinary Medicine. § 301.7701–2 Business entities;
■ 7. Revise § 526.1696a to read as [FR Doc. E8–7103 Filed 4–3–08; 8:45 am] definitions.
follows: BILLING CODE 4160–01–S * * * * *

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