[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Rules and Regulations]
[Pages 51820-51821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25904]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Oral Dosage Form New Animal Drugs; Streptomycin Oral Solution

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by Contemporary Products, Inc. The ANADA 
provides for the use of streptomycin oral solution in drinking water 
for the treatment of nonspecific infectious enteritis in chickens and 
for the treatment of bacterial enteritis in swine and calves.

EFFECTIVE DATE: September 29, 1998.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Contemporary Products, Inc., 3788 Elm 
Springs Rd., P.O. Box 6067, Springdale, AR 72766-6067, filed ANADA 200-
197 that provides for the use of streptomycin oral solution in drinking 
water for the treatment of nonspecific infectious enteritis in chickens 
and for the treatment of bacterial enteritis in swine and calves.
    Contemporary Products, Inc.'s ANADA 200-197 is approved as a 
generic copy of Veterinary Services, Inc.'s NADA 065-252. ANADA 200-197 
is approved as of August 3, 1998, and the regulations are amended in 21 
CFR 520.2158a to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
    Contemporary Products, Inc., is not currently listed in the animal 
drug regulations as the sponsor of an approved application. At this 
time, 21 CFR 510.600(c)(1) and (c)(2) are amended by adding a new 
listing for the sponsor.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this application 
may be seen in the Dockets Management Branch (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.
    The agency has determined under 21 CFR 25.33(a)(1) 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.

List of Subjects

21 CFR Part 510

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

[[Page 51821]]

21 CFR Part 520

    Animal drugs.
    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 and 
520 are amended as follows:

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.

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``Contemporary Products, Inc.'' 
and in the table in paragraph (c)(2) by numerically adding a new entry 
for ``055462'' 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
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
Contemporary Products, Inc., 3788 Elm Springs Rd.,
 Springdale, AR 72764-6067                                       055462
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
 Drug labeler code                  Firm name and address
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
055462............  Contemporary Products, Inc., 3788 Elm Springs Rd.,
                     Springdale, AR 72764-6067
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

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.

Sec. 520.2158a  [Amended]

    4. Section 520.2158a Streptomycin sulfate oral solution is amended 
in paragraph (b) by removing the phrase ``No. 033008'' and adding in 
its place `` Nos. 033008 and 055462''.

    Dated: August 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-25904 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F