Beruflich Dokumente
Kultur Dokumente
available to each date handler in Dated: March 2, 2005. Accordingly, the agency is amending
Riverside County. Kenneth C. Clayton, the regulations in 21 CFR 510.600(c) to
(e) Each approved manufacturer of Acting Administrator, Agricultural Marketing reflect the change.
date products is required to renew their Service. This rule does not meet the definition
approved manufacturer status with the [FR Doc. 05–4448 Filed 3–7–05; 8:45 am] of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
BILLING CODE 3410–02–P it is a rule of ‘‘particular applicability.’’
committee by submitting an updated
Therefore, it is not subject to the
CDAC Form No. 3 at the end of a crop
congressional review requirements in 5
year, but no later than October 10 of the
DEPARTMENT OF HEALTH AND U.S.C. 801–808.
new crop year. In addition, the
approved manufacturer must continue HUMAN SERVICES List of Subjects in 21 CFR Part 510
to meet the other approved Food and Drug Administration Administrative practice and
manufacturer qualification procedure, Animal drugs, Labeling,
requirements. 21 CFR Part 510 Reporting and recordkeeping
(f) In the event an approved date requirements.
product manufacturer who is also a New Animal Drugs; Change of ■ Therefore, under the Federal Food,
regulated date handler within the area Sponsor’s Address Drug, and Cosmetic Act and under
of production does not remain in AGENCY: Food and Drug Administration, authority delegated to the Commissioner
compliance with the order, or fails or HHS. of Food and Drugs and redelegated to the
refuses to submit reports or to pay ACTION: Final rule. Center for Veterinary Medicine, 21 CFR
assessments required by the committee, part 510 is amended as follows:
such date product manufacturer shall SUMMARY: The Food and Drug
become ineligible to continue as an Administration (FDA) is amending the PART 510—NEW ANIMAL DRUGS
approved date product manufacturer. animal drug regulations to reflect a
change of sponsor’s address for ■ 1. The authority citation for 21 CFR
Prior to making a determination to part 510 continues to read as follows:
Wellmark International.
remove a date product manufacturer
DATES: This rule is effective March 8, Authority: 21 U.S.C. 321, 331, 351, 352,
from the approved date product 353, 360b, 371, 379e.
2005.
manufacturer list, the committee shall ■ 2. Section 510.600 is amended in the
notify such manufacturer in writing of FOR FURTHER INFORMATION CONTACT:
table in paragraph (c)(1) by revising the
its intention and the reasons for David R. Newkirk, Center for Veterinary
entry for ‘‘Wellmark International’’; and
removal. The committee shall allow the Medicine (HFV–100), Food and Drug
in the table in paragraph (c)(2) by
date product manufacturer an Administration, 7500 Standish Pl.,
revising the entry for ‘‘011536’’ to read
opportunity to respond. In the event Rockville, MD 20855, 301–827–6967, e-
as follows:
that a date product manufacturer’s name mail: david.newkirk@fda.gov.
has been removed from the list of SUPPLEMENTARY INFORMATION: Wellmark § 510.600 Names, addresses, and drug
International, 1100 East Woodfield Rd., labeler codes of sponsors of approved
approved date product manufacturers, a applications.
new application must be submitted to suite 500, Schaumburg, IL 60173 has
the committee and the applicant must informed FDA of a change of address to * * * * *
1501 East Woodfield Rd., suite 200 (c) * * *
await approval.
West, Schaumburg, IL 60173. (1) * * *
Drug labeler
Firm name and address code
* * * * *
* * * * *
(2) * * *
* * * * *
* * * * *
VerDate jul<14>2003 11:16 Mar 07, 2005 Jkt 205001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\08MRR1.SGM 08MRR1
Federal Register / Vol. 70, No. 44 / Tuesday, March 8, 2005 / Rules and Regulations 11121
26 CFR Part 1
VerDate jul<14>2003 11:16 Mar 07, 2005 Jkt 205001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\08MRR1.SGM 08MRR1