# [Amended]
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Final rule; technical amendment.
**SUMMARY:**
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of seven new animal drug applications (NADAs) because FDA is withdrawing approval of the NADAs.
**DATES:**
This rule is effective April 4, 2008.
**FOR FURTHER INFORMATION CONTACT:**
Pamela K. Esposito, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9067; e-mail: *[email protected]* .
**SUPPLEMENTARY INFORMATION:**
The following sponsors have requested that FDA withdraw approval of the seven NADAs listed below because the products are no longer manufactured or marketed:
| Sponsor | NADA Number Product (Drug) | 21 CFR Cite Affected |
| --- | --- | --- |
| Eon Labs Manufacturing, Inc., | NADA 65-063, | 520.2345a (000185) |
| | NADA 65-345, | 520.390b (000185) |
| G.C. Hanford Manufacturing Co., | NADA 65-465, | 526.1696a (010515) |
| International Nutrition, Inc., | NADA 95-551, | 558.625 (043733) |
| | NADA 109-688, | 558.274 (043733) |
| | NADA 109-816, | 558.630 (043733) |
| Pfizer, Inc., | NADA 103-758, | Not codified |
Following the withdrawal of approval of these NADAs, Eon Labs Manufacturing, Inc., is no longer sponsor of an approved application. Therefore, 21 CFR 510.600(c) is amended to remove entries for this sponsor.
As provided below, the animal drug regulations are amended to reflect the withdrawal of approvals. The regulations for penicillin G procaine intramammary dosage forms (21 CFR 526.1696a) are also amended to correct several errors and to reflect a current format.
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**
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Animal drugs.
Animal drugs, Animal feeds.
**21 CFR Part 510, 520, 526, 558**
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 520, 526, and 558 are amended as follows:
**21 CFR Part 510**
**PART 510—NEW ANIMAL DRUGS**
1. The authority citation for 21 CFR part 510 continues to read as follows:
**Authority:**
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
**21 CFR Part 510**
§ 510.600
2. In § 510.600, in the table in paragraph (c)(1), remove the entry for “Eon Labs Manufacturing, Inc.”; and in the table in paragraph (c)(2) remove the entry for “000185”.
**21 CFR Part 520**
**PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS**
3. The authority citation for 21 CFR part 520 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 520**
§ 520.390b
4. In § 520.390b, in paragraph (b)(1), remove “, 000185,”.
**21 CFR Part 520**
§ 520.2345a
5. In § 520.2345a, remove paragraph (b)(3).
**21 CFR Part 526**
**PART 526—INTRAMAMMARY DOSAGE FORMS**
6. The authority citation for 21 CFR part 526 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 526**
7. Revise § 526.1696a to read as follows:
§ 526.1696a
(a) *Specifications* . Each 10-milliliter single-dose syringe contains penicillin G procaine equivalent to 100,000 units of penicillin G.
(b) *Related tolerances* . See § 556.510 of this chapter.
(c) *Sponsors* . See Nos. 010515 and 050604 in § 510.600(c) of this chapter.
(d) *Conditions of use in lactating cows* —(1) *Amount* . Infuse one 10-milliliter dose into each infected quarter. Treatment may be repeated at 12-hour intervals for not more than three doses, as indicated by clinical response.
(2) *Indications for use* . For the treatment of mastitis caused by *Streptococcus agalactiae* , *S. dysgalactiae* , and *S. uberus* in lactating cows.
(3) *Limitations* . Milk that has been taken from animals during treatment and for 60 hours after the latest treatment must not be used for food. Animals must not be slaughtered for food during treatment or within 3 days after the latest treatment.
(e) *Conditions of use in dry cows* —(1) *Amount* . Infuse one 10-milliliter dose into each infected quarter at time of drying-off.
(2) *Indications of use* . For the treatment of mastitis caused by *Streptococcus agalactiae* in dry cows.
(3) *Limitations* . Discard all milk for 72 hours (6 milkings) following calving, or later as indicated by the marketable quality of the milk. Animals must not be slaughtered for food within 14 days postinfusion.
**21 CFR Part 558**
**PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS**
8. The authority citation for 21 CFR part 558 continues to read as follows:
**Authority:**
21 U.S.C. 360b, 371.
**21 CFR Part 558**
§ 558.274
9. In § 558.274, amend paragraph (a)(2) by removing “Nos. 043733 and” and adding in its place “No.”.
**21 CFR Part 558**
§ 558.625
10. In § 558.625, remove and reserve paragraph (b)(3).
**21 CFR Part 558**
§ 558.630
11. In § 558.630, amend paragraph (b)(10) by removing “043733,”.
Dated: March 26, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.