[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