[Federal Register Volume 62, Number 98 (Wednesday, May 21, 1997)]
[Rules and Regulations]
[Pages 27691-27692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 558


Animal Drugs, Feeds, and Related Products; Drug Labeler Code; 
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 amending the animal 
drug regulations to reflect the correct drug labeler code for the ADM 
Animal Health & Nutrition Division that is used in title 21 of the Code 
of Federal Regulations. This action is being taken to ensure the 
accuracy of the regulations.

EFFECTIVE DATE: May 21, 1997.

FOR FURTHER INFORMATION CONTACT: David L. Gordon, Center for Veterinary 
Medicine (HFV-238), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1737.

SUPPLEMENTARY INFORMATION: Parts 510, 520, and 558 (21 CFR parts 510, 
520, and 558) contain references to the incorrect drug labeler code 
number for ADM Animal Health and Nutrition Division. FDA is correcting 
the regulations in Secs. 510.600, 520.445b, 558.128, 558.274, 558.485, 
558.625, and 558.630 by removing ``012286'' and adding in its place 
``017519''.

List of Subjects

21 CFR Part 510

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

21 CFR Part 520

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.
    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, 
520, 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: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).

Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) in the entry for ``ADM Animal Health & Nutrition Div.'' and in 
paragraph (c)(2) in the entry for ``012286'' by removing ``012286'' and 
adding in its place ``017519'', and in paragraph (c)(2) placing the 
entry in alphanumeric order.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 520.445b  [Amended]

    4. Section 520.445b Chlortetracycline powder (chlortetracycline 
hydrochloride or chlortetracycline bisulfate) is amended in paragraph 
(b) by removing ``012286'' and adding in its place ``017519''.

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

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


[[Page 27692]]


    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).


Sec. 558.128  [Amended]

    6. Section 558.128 Chlortetracycline is amended in paragraph (a)(4) 
and in the table in paragraph (d)(1) in the ``sponsor'' column by 
removing ``012286'' each time it appears and adding in its place 
``017519''.

Sec. 558.274  [Amended]

    7. Section 558.274 Hygromycin B is amended in paragraph (a)(7) and 
in the table in paragraph (c)(1), under the ``sponsor''column, by 
removing ``012286'' each time it appears and adding in its place, 
``017519''.

Sec. 558.485  [Amended]

    8. Section 558.485 Pyrantel tartrate is amended in paragraph 
(a)(11) by removing ``012286'' and adding in its place``017519''.

Sec. 558.625  [Amended]

    9. Section 558.625 Tylosin is amended in paragraphs (b)(10) and 
(b)(52) by removing ``012286'' and adding in its place ``017519''.

Sec. 558.630  [Amended]

    10. 558.630 Tylosin and sulfamethazine is amended in paragraphs 
(b)(3), (b)(8), and (b)(10) by removing ``012286'' and adding in its 
place ``017519''.


    Dated: May 7, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-13269 Filed 5-20-97; 8:45 am]
BILLING CODE 4160-01-F