[Federal Register Volume 65, Number 174 (Thursday, September 7, 2000)]
[Rules and Regulations]
[Pages 54147-54148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22949]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558


Animal Drugs, Feeds, and Related Products; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is updating the animal 
drug regulations to add Triple ``F'', Inc., to the list of sponsors of 
approved animal drug applications, and to add the drug labeler code 
(DLC) number for ADM Animal Health & Nutrition Division (ADM) to the 
list of approvals for bambermycins. These corrections amend the animal 
drug regulations to reflect currently approved new animal drug 
applications (NADA's).

DATES: This rule is effective September 7, 2000.

FOR FURTHER INFORMATION CONTACT: Judith M. O'Haro, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-3664.

SUPPLEMENTARY INFORMATION: FDA has found that the April 1, 2000, 
edition of Title 21, Parts 500 to 599 of the Code of Federal 
Regulations (CFR) does not fully reflect several approved NADA's. 
Triple ``F'', Inc., is the holder of approved new animal drug 
applications (NADA's). The former DLC number for Triple ``F'', Inc., 
011490, is listed in the regulation for bambermycins in Sec. 558.95 (21 
CFR 558.95) and for pyrantel tartrate in 21 CFR 558.485, but the 
sponsor and DLC are not listed under sponsors of approved applications 
in Sec. 510.600(c) (21 CFR 510.600(c)). In a document published in the 
Federal Register of April 1, 1999 (64 FR 15683), the listing for Triple 
``F,'' Inc., was inadvertently deleted from Sec. 510.600(c). ADM is a 
holder of approved NADA 132-448 for the use of bambermycins, but is not 
listed in the bambermycins regulations (Sec. 558.95) by its current 
DLC. ADM is listed in Sec. 558.95(a)(4) by its former DLC, 012286. This 
DLC was changed to 017519 in the Federal Register of May 21, 1997 (62 
FR 27691), but the change was not reflected in Sec. 558.95. At this 
time, FDA is amending the regulations to correct these errors in 
Secs. 510.600(c) and 558.95(a).
    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 558

    Animal drugs, Animal feeds.

    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 
558 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 
adding alphabetically an entry for ``Triple `F','' Inc.'' and in the 
table in paragraph (c)(2) by adding numerically an entry for ``011490'' 
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
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  *                    *                    *                    *
                   *                    *                    *
Triple ``F'', Inc., 10104 Douglas     011490
 Ave., Des Moines, IA 50322
 
  *                    *                    *                    *
                   *                    *                    *
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    (2) * * *

 
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
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  *                    *                    *                    *
                   *                    *                    *
011490                               Triple ``F'', Inc., 10104 Douglas
                                      Ave., Des Moines, IA 50322
 
  *                    *                    *                    *
                   *                    *                    *
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[[Page 54148]]

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec. 558.95  [Amended]

    4. Section 558.95 Bambermycins is amended in paragraph (a)(4) by 
removing ``012286'' and by numerically adding ``017519,''.

    Dated: August 23, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-22949 Filed 9-6-00; 8:45 am]
BILLING CODE 4160-01-F