[Federal Register Volume 63, Number 245 (Tuesday, December 22, 1998)]
[Rules and Regulations]
[Page 70650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33830]



[[Page 70650]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization; Center for Veterinary 
Medicine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
delegations of authority with respect to animal drugs to incorporate 
provisions for feed mill licensing in accordance with the Animal Drug 
Availability Act (ADAA) of 1996. The ADAA amended some sections of the 
Federal Food, Drug, and Cosmetic Act (the act) to require a single 
facility license for the manufacturer of medicated feeds containing 
approved new animal drugs, rather than multiple medicated feed 
applications for each feed mill, as previously required by the act. 
This notice also updates position and component titles and associated 
delegations of authority within the Center for Veterinary Medicine 
(CVM) as a result of organizational restructuring.

EFFECTIVE DATE: December 22, 1998.

FOR FURTHER INFORMATION CONTACT:
    Richard L. Arkin, Center for Veterinary Medicine, Food and Drug 
Administration, 7600 Standish Pl., Rockville, MD 20855, 301-827-0141, 
or
    Loretta W. Davis, Division of Management Systems and Policy (HFA-
340), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-4809.

SUPPLEMENTARY INFORMATION: FDA is amending the delegations of authority 
in subpart B of part 5 (21 CFR part 5) in order to revise Secs. 5.83 
and 5.84 to include additional authorities with regard to the approval 
of the medicated feed mill license applications. The ADAA (Pub. L. 104-
250) amended section 512(a) and (m) of the act (21 U.S.C. 360b(a) and 
(m)). Moreover, this final rule reflects specific organizational, 
position, and title revisions within CVM due to organizational 
restructuring of specific components.
    Further redelegation of the authorities delegated is not authorized 
at this time. Authority delegated to a position may be exercised by a 
person officially designated to serve in such position in an acting 
capacity or on a temporary basis.

 List of Subjects in 21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
5 is amended as follows:

PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION

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

    Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15 
U.S.C. 638, 1261-1282, 3701-3711a; 15 U.S.C. 1451-1461; 21 U.S.C. 
41-50, 61-63, 141-149, 321-394, 467f, 679(b), 801-886, 1031-1309; 35 
U.S.C. 156; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 
264, 265, 300u-300u-5, 300aa-1; 1395y, 3246b, 4332, 4831(a), 10007-
10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O. 
12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223.

    2. Section 5.83 is amended by revising the section heading, 
paragraphs (c)(1) and (c)(2), and paragraph (d) to read as follows:


Sec.  5.83  Approval of new animal drug applications, medicated feed 
mill license applications and their supplements.

* * * * *
    (c) * * *
    (1) The Director, Division of Human Food Safety, Office of New 
Animal Drug Evaluation, CVM.
    (2) The Director, Division of Epidemiology and Surveillance, Office 
of Surveillance and Compliance, CVM.
    (d) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs with regard to the 
approval of medicated feed mill license applications for the 
manufacture of animal feeds containing new animal drugs pursuant to 
section 512(m) of the act, as amended by the Animal Drug Availability 
Act of 1996 (Pub. L. 104-250):
    (1) The Director and Deputy Director, CVM.
    (2) The Director, Division of Animal Feeds, Office of Surveillance 
and Compliance, CVM.
    (3) The Leader, Medicated Feeds Team, Division of Animal Feeds, 
Office of Surveillance and Compliance, CVM.
    (4) The Medicated Feeds Specialist, Medicated Feeds Team, Division 
of Animal Feeds, Office of Surveillance and Compliance, CVM.
    3. Section 5.84 is amended by revising the section heading and 
paragraphs (a)(1) and (a)(3) to read as follows:


Sec. 5.84  Issuance of notices, proposals, and orders relating to new 
animal drugs and medicated feed mill license applications.

    (a) * * *
    (1) Issue notices of opportunity for a hearing on proposals to 
refuse approval or to withdraw approval of new animal drug 
applications, and supplements thereto, for drugs for animal use and 
proposals to refuse approval or to revoke approval of medicated feed 
mill license applications, and supplements thereto, submitted pursuant 
to section 512(m) of the Federal Food, Drug, and Cosmetic Act, as 
amended by the Animal Drug Availability Act of 1996 (Pub. L. 104-250).
* * * * *
    (3) Issue proposals and orders to revoke and amend regulations for 
new animal drugs for animal use and medicated feed mill licenses, 
corresponding to said act on such applications.
* * * * *

    Dated: December 14, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 98-33830 Filed 12-21-98; 8:45 am]
BILLING CODE 4160-01-F