[Federal Register Volume 68, Number 160 (Tuesday, August 19, 2003)]
[Rules and Regulations]
[Pages 49703-49704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522


Injectable or Implantable Dosage Form New Animal Drugs; Estradiol 
Benzoate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of two new animal drug 
applications (NADAs) filed by PR Pharmaceuticals, Inc. The NADAs 
provide for subcutaneous injection, in the ear only, of a suspension 
implant of estradiol benzoate microspheres for increased rate of weight 
gain in suckling beef calves, and for increased rate of weight gain and 
improved feed efficiency in steers and heifers fed in confinement for 
slaughter.

DATES: This rule is effective August 19, 2003.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: PR Pharmaceuticals, Inc., 1716 Heath Pkwy., 
Fort Collins, CO 80524, filed NADA 141-040 that provides for use of 
CELERIN (estradiol benzoate), microspheres for constitution into a 
suspension, by subcutaneous injection in the ear only for increased 
rate of weight gain and improved feed efficiency in steers and heifers 
fed in confinement for slaughter. PR Pharmaceuticals, Inc., also filed 
NADA 141-041 that provides for use of CELERIN C (estradiol benzoate), 
also microspheres for constitution, by subcutaneous injection in the 
ear only for increased rate of weight gain in suckling beef calves. The 
NADAs are approved as of June 25, 2003, and the regulations are amended 
in 21 CFR part 522 by adding new Sec.  522.841 to reflect the 
approvals. The basis of approval is discussed in the freedom of 
information summaries.
    In addition, PR Pharmaceuticals, Inc., has not been previously 
listed in the animal drug regulations as a sponsor of an approved 
application. At this time, 21 CFR 510.600(c) is being amended to add 
entries for the firm.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii),

[[Page 49704]]

summaries of safety and effectiveness data and information submitted to 
support approval of these applications may be seen in the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., 
Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(ii)), these approvals 
qualify for 3 years of marketing exclusivity beginning June 25, 2003.
    The agency has determined under 21 CFR 25.33(c) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522

    Animal drugs.

0
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 510 and 
522 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
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.

0
2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding an entry for ``PR Pharmaceuticals, Inc.'' and in 
the table in paragraph (c)(2) by numerically adding an entry for 
``067210'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
PR Pharmaceuticals, Inc., 1716 Heath Pkwy.,   067210
 Fort Collins, CO 80524.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
067210                       PR Pharmaceuticals, Inc., 1716 Heath Pkwy.,
                              Fort Collins, CO 80524.
                                * * * * *
------------------------------------------------------------------------

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
4. Section 522.841 is added to read as follows:


Sec.  522.841  Estradiol benzoate.

    (a) Specifications. The product consists of a vial of estradiol 
benzoate microspheres and a vial of diluent.
    (1) Each milliliter (mL) of constituted suspension contains 10 
milligrams (mg) estradiol benzoate.
    (2) Each mL of constituted suspension contains 20 mg estradiol 
benzoate.
    (b) Sponsor. See No. 067210 in Sec.  510.600(c) of this chapter.
    (c) Tolerances. See Sec.  556.240 of this chapter.
    (d) Conditions of use. It is used by subcutaneous injection as 
follows:
    (1) Suckling beef calves--(i) Amount. 10 mg; 1 mL of the product 
described in paragraph (a)(1) of this section.
    (ii) Indications for use. For increased rate of weight gain.
    (iii) Limitations. For subcutaneous injection in the ear only. Do 
not use in calves intended for reproduction or calves less than 30 days 
old. A withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.
    (2) Steers fed in confinement for slaughter--(i) Amount--(A) 20 mg; 
1 mL of the product described in paragraph (a)(2) of this section for 
use in paragraph (d)(2)(ii)(A) of this section.
    (B) 10 mg; 0.5 mL of the product described in paragraph (a)(2) of 
this section for use in paragraph (d)(2)(ii)(B) of this section.
    (ii) Indications for use--(A) For improved feed efficiency.
    (B) For increased rate of weight gain.
    (iii) Limitations. For subcutaneous injection in the ear only. The 
use of 20 mg (1 mL) in steers does not provide additional rate of gain 
improvement over 10 mg (0.5 mL). Do not use in calves intended for 
reproduction or calves less than 30 days old. A withdrawal period has 
not been established for this product in preruminating calves. Do not 
use in calves to be processed for veal.
    (3) Heifers fed in confinement for slaughter--(i) Amount. One mL 
(20 mg) of product described in paragraph (a)(2) of this section.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (iii) Limitations. For subcutaneous injection in the ear only. Do 
not use in calves intended for reproduction or calves less than 30 days 
old. A withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.

    Dated: July 25, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-21113 Filed 8-18-03; 8:45 am]
BILLING CODE 4160-01-S